OVERVIEW + STUDY DETAILS

Follow the evidence.

Start with the finding and its limits.
Open the study details to look closer.

Controlled study

Acute stress, cortisol and intake: the Geliebter experiment

In Geliebter's experiment involving 20 women with obesity, comparing a cold pressor with warm water on counterbalanced days, no statistically significant relationship was found between the cortisol response and food intake.

Evidence design
Controlled, counterbalanced crossover experiment; order randomization unverified
Population
Twenty women with obesity, assessed while fasting and after an acute laboratory stressor.

Keep in view

  • Experiment in 20 women; counterbalanced days, with order randomization unverified in the consulted scope.
  • A statistically nonsignificant association does not establish the absence of any relationship.
  • Do not extrapolate the acute laboratory stressor to chronic stress or weight loss.
See study details — Cortisol and intake experiment

Study design and methods

Controlled, counterbalanced crossover experiment; order randomization unverified

Controlled crossover experiment on two counterbalanced days: a hand in ice-cold water for two minutes versus warm water. Random assignment of the order was not confirmed; do not label it a randomized trial.

Population

Twenty women with obesity, assessed while fasting and after an acute laboratory stressor.

Study design
Controlled crossover experiment on two counterbalanced days: a hand in ice-cold water for two minutes versus warm water. Random assignment of the order was not confirmed; do not label it a randomized trial.
Reported sample count
20
Role of the reported sample count
Reported study sample; not necessarily the denominator for each outcome
Included study count
1
Role of the study count
Single study
Research question
Does the cortisol response to an acute stressor predict appetite or intake at a subsequent meal?
Qualified findings
The ice-cold-water test increased cortisol and perceived stress but did not increase intake at the test meal. Hunger and desire to eat decreased in acute measurements; cortisol concentration did not show a significant relationship with subsequent intake in this experiment.
Estimand and analysis rules
Not reported or not verified
Reason the formal estimand is unavailable
A complete formal estimand was not extracted from the verified input.

What the curated evidence supports

  • In Geliebter's experiment involving 20 women with obesity, comparing a cold pressor with warm water on counterbalanced days, no statistically significant relationship was found between the cortisol response and food intake.

Limitations

  • Experiment in 20 women; counterbalanced days, with order randomization unverified in the consulted scope.
  • A statistically nonsignificant association does not establish the absence of any relationship.
  • Do not extrapolate the acute laboratory stressor to chronic stress or weight loss.

Verification scope

Verified through 2026-11-04 within the consulted scope.

Bibliographic metadata checked
Yes
Original article abstract consulted
Yes
Full-text consultation
Not consulted
full text verified fields
    Official trial registry consulted
    No
    Statistical analysis plan consulted
    No
    Verification boundary
    Verification is limited to the input's identified abstract/full-text fields. A trial identifier linked by an article does not imply a separate registry review.

    Source record

    Plasma cortisol levels in response to a cold pressor test did not predict appetite or ad libitum test meal intake in obese women (2012)

    Evidence review

    Stress and eating: average associations in the Hill review

    In Hill's review, stress showed small average associations with higher total intake (g=0.114), greater intake of foods the studies classified as less healthy (g=0.116), and lower intake of foods classified as healthy (g=−0.111).

    Evidence design
    Systematic review and meta-analysis
    Population
    Healthy adults; explicitly defined stress measures and varied eating behaviors.
    Assessment period
    Varying protocols and time points across the review
    Reported units
    Hedges’ g

    Keep in view

    • Small average effects and between-study heterogeneity; not everyone's response.
    • 119,820 is the review-wide total; each effect's denominator was not verified.
    • Food categories come from the studies; they do not morally characterize people who eat them.
    • It does not establish cortisol as a causal mediator.
    See study details — Stress and eating review

    Review design and extraction scope

    Systematic review and meta-analysis

    Systematic review and meta-analysis of 54 studies on stress and non-disordered eating.

    Population

    Healthy adults; explicitly defined stress measures and varied eating behaviors.

    Study design
    Systematic review and meta-analysis of 54 studies on stress and non-disordered eating.
    Reported sample count
    119820
    Role of the reported sample count
    Review-wide total; not an outcome-specific denominator
    Included study count
    54
    Role of the study count
    Review-wide total; not an outcome-specific denominator
    Research question
    What is the magnitude of the relationship between stress and total intake or food choices?
    Qualified findings
    Stress was associated with a small average increase in intake and in consumption of foods classified as less healthy, and with lower consumption of those classified as healthy. Significant heterogeneity was not explained by the moderators examined.
    Estimand and analysis rules
    Not reported or not verified
    Reason the formal estimand is unavailable
    A complete formal estimand was not extracted from the verified input.

    How to read this review

    Included studies may differ in population, design and outcomes. Review-wide counts describe coverage and cannot be used as the sample size of every estimate.

    Included studies: 54 — Review-wide total; not an outcome-specific denominator.

    Extracted review results and scope

    Study counts describe review scope. Review-wide participant totals are not outcome-specific denominators.

    Reported values, analysis populations and uncertainty, preserved from the curated extraction.
    Outcome and groupReported valueAssessment periodSample and denominatorsUncertainty
    Association with total intake

    Stress–eating association

    Effect estimate

    0.114 Hedges’ g

    standardized association

    Unit: Hedges’ g

    Varying protocols and time points across the review

    Reported N: 119820 — review-wide participants; not an outcome-specific denominator

    • 119820 — review total participants; scope: all review studies
    • 54 — review total studies; scope: all review studies
    • Not reported or not verified — outcome specific participants; scope: total intake association
    • Not reported or not verified — outcome specific studies; scope: total intake association

    Each effect's CI and denominator were not verified in the abstract.

    Association with foods classified as less healthy in the studies

    Stress–eating association

    Effect estimate

    0.116 Hedges’ g

    standardized association

    Unit: Hedges’ g

    Varying protocols and time points across the review

    Reported N: 119820 — review-wide participants; not an outcome-specific denominator

    • 119820 — review total participants; scope: all review studies
    • 54 — review total studies; scope: all review studies
    • Not reported or not verified — outcome specific participants; scope: study defined less healthy food intake
    • Not reported or not verified — outcome specific studies; scope: study defined less healthy food intake

    Each effect's CI and denominator were not verified in the abstract.

    Association with foods classified as healthy in the studies

    Stress–eating association

    Effect estimate

    -0.111 Hedges’ g

    standardized association

    Unit: Hedges’ g

    Varying protocols and time points across the review

    Reported N: 119820 — review-wide participants; not an outcome-specific denominator

    • 119820 — review total participants; scope: all review studies
    • 54 — review total studies; scope: all review studies
    • Not reported or not verified — outcome specific participants; scope: study defined healthier food intake
    • Not reported or not verified — outcome specific studies; scope: study defined healthier food intake

    Each effect's CI and denominator were not verified in the abstract.

    Association with total intake — Stress–eating association: extraction context
    Outcome role
    Not specified in the consulted scope
    Scale reference
    standardized_effect
    Extraction location
    Original systematic-review abstract
    • Synthesis of varied designs; do not interpret it as one causal trial.
    Association with foods classified as less healthy in the studies — Stress–eating association: extraction context
    Outcome role
    Not specified in the consulted scope
    Scale reference
    standardized_effect
    Extraction location
    Original systematic-review abstract
    • Synthesis of varied designs; do not interpret it as one causal trial.
    Association with foods classified as healthy in the studies — Stress–eating association: extraction context
    Outcome role
    Not specified in the consulted scope
    Scale reference
    standardized_effect
    Extraction location
    Original systematic-review abstract
    • Synthesis of varied designs; do not interpret it as one causal trial.

    What the curated evidence supports

    • In Hill's review, stress showed small average associations with higher total intake (g=0.114), greater intake of foods the studies classified as less healthy (g=0.116), and lower intake of foods classified as healthy (g=−0.111).

    Limitations

    • Small average effects and between-study heterogeneity; not everyone's response.
    • 119,820 is the review-wide total; each effect's denominator was not verified.
    • Food categories come from the studies; they do not morally characterize people who eat them.
    • It does not establish cortisol as a causal mediator.

    Verification scope

    Verified through 2026-11-04 within the consulted scope.

    Bibliographic metadata checked
    Yes
    Original article abstract consulted
    Yes
    Full-text consultation
    Not consulted
    full text verified fields
      Official trial registry consulted
      No
      Statistical analysis plan consulted
      No
      Verification boundary
      Verification is limited to the input's identified abstract/full-text fields. A trial identifier linked by an article does not imply a separate registry review.

      Source record

      Stress and eating behaviours in healthy adults: a systematic review and meta-analysis (2022)

      Evidence review

      Sleep duration, food intake and hormones: a trial review

      The review of 50 trials found indications of greater intake, hunger and appetite with sleep restriction, but not a consistent pattern of changes in leptin, ghrelin and cortisol.

      Evidence design
      Systematic review of randomized clinical trials
      Population
      Adults, children and adolescents; varied populations and experimental conditions.
      Assessment period
      Study count, with no single intervention duration
      Reported units
      trials

      Keep in view

      • Protocols and age groups varied; no single verified magnitude applies to all outcomes.
      • 50 counts trials, not participants or the denominator for each outcome.
      • Reviews may share trials; do not sum their samples as independent evidence.
      See study details — Sleep restriction review

      Review design and extraction scope

      Systematic review of randomized clinical trials

      Systematic review of randomized trials; search through July 2020.

      Population

      Adults, children and adolescents; varied populations and experimental conditions.

      Study design
      Systematic review of randomized trials; search through July 2020.
      Reported sample count
      Not reported or not verified
      Role of the reported sample count
      Review-wide total; not an outcome-specific denominator
      Included study count
      50
      Role of the study count
      Review-wide total; not an outcome-specific denominator
      Research question
      How does sleep duration affect intake, desire to eat, body measurements and hormones?
      Qualified findings
      The review suggests greater intake, hunger and appetite with sleep restriction. The synthesis did not identify a consistent influence on leptin, ghrelin and cortisol. This supports cautious wording about hormonal mechanisms.
      Estimand and analysis rules
      Not reported or not verified
      Reason the formal estimand is unavailable
      A complete formal estimand was not extracted from the verified input.

      How to read this review

      Included studies may differ in population, design and outcomes. Review-wide counts describe coverage and cannot be used as the sample size of every estimate.

      Included studies: 50 — Review-wide total; not an outcome-specific denominator.

      Extracted review results and scope

      Study counts describe review scope. Review-wide participant totals are not outcome-specific denominators.

      Reported values, analysis populations and uncertainty, preserved from the curated extraction.
      Outcome and groupReported valueAssessment periodSample and denominatorsUncertainty
      Trials included in the review

      Review scope

      Review scope count; not a clinical effect

      50 trials

      Included study count

      Unit: trials

      Study count, with no single intervention duration

      Participant N: not applicable to a study count

      • Not reported or not verified — review total participants not verified; scope: review

      Review-scope count, not an estimated effect; a CI is not applicable.

      Trials included in the review — Review scope: extraction context
      Outcome role
      Not specified in the consulted scope
      Extraction location
      Original systematic-review abstract
      • 43 adult trials and seven child/adolescent trials; do not use 50 as a participant denominator.

      What the curated evidence supports

      • The review of 50 trials found indications of greater intake, hunger and appetite with sleep restriction, but not a consistent pattern of changes in leptin, ghrelin and cortisol.

      Limitations

      • Protocols and age groups varied; no single verified magnitude applies to all outcomes.
      • 50 counts trials, not participants or the denominator for each outcome.
      • Reviews may share trials; do not sum their samples as independent evidence.

      Verification scope

      Verified through 2026-11-04 within the consulted scope.

      Bibliographic metadata checked
      Yes
      Original article abstract consulted
      Yes
      Full-text consultation
      Not consulted
      full text verified fields
        Official trial registry consulted
        No
        Statistical analysis plan consulted
        No
        Verification boundary
        Verification is limited to the input's identified abstract/full-text fields. A trial identifier linked by an article does not imply a separate registry review.

        Source record

        Effect of sleep duration on dietary intake, desire to eat, measures of food intake and metabolic hormones: A systematic review of clinical trials (2021)

        Controlled study

        Sleep extension and energy intake: the Tasali trial

        In Tasali's trial involving 80 adults with overweight and short sleep, two weeks of sleep extension produced a −270 kcal/day difference in the change in estimated energy intake relative to control (95% CI −393 to −147).

        In the same trial, the difference in sleep duration was 1.2 hours per night in favor of the intervention (95% CI 1.0–1.4).

        Weight results during 68 or 72 treatment weeks and a two-week sleep intervention answer different questions from a withdrawal comparison after initial treatment. SURMOUNT-4 provides that specific comparison for 52 weeks after randomization.

        Evidence design
        Randomized parallel clinical trial
        Population
        Adults aged 21–40 years, with BMI 25.0–29.9 kg/m² and habitual sleep shorter than 6.5 h/night.
        Assessment period
        Two intervention weeks following two baseline weeks
        Reported units
        kcal/day; hours/night

        Keep in view

        • 80 adults aged 21–40 with overweight and habitual sleep shorter than 6.5 hours; single center.
        • Two intervention weeks do not establish sustained weight-loss maintenance.
        • Intake was estimated from energy balance, not measured by directly counting food.
        See study details — Sleep extension trial

        Study design and methods

        Randomized parallel clinical trial

        Single-center randomized trial; two baseline weeks and two intervention weeks in the usual environment; intention-to-treat analysis.

        Population

        Adults aged 21–40 years, with BMI 25.0–29.9 kg/m² and habitual sleep shorter than 6.5 h/night.

        Study design
        Single-center randomized trial; two baseline weeks and two intervention weeks in the usual environment; intention-to-treat analysis.
        Reported sample count
        80
        Role of the reported sample count
        Reported study sample; not necessarily the denominator for each outcome
        Included study count
        1
        Role of the study count
        Single study
        Research question
        Does extending sleep reduce objectively estimated energy intake in adults with overweight and short sleep?
        Qualified findings
        Counseling to extend sleep increased sleep duration and reduced estimated intake compared with control. Total expenditure did not differ significantly. This is a two-week finding; it does not demonstrate weight-loss maintenance.
        Estimand and analysis rules
        Not reported or not verified
        Reason the formal estimand is unavailable
        A complete formal estimand was not extracted from the verified input.

        Extracted outcomes

        Reported values, analysis populations and uncertainty, preserved from the curated extraction.
        Outcome and groupReported valueAssessment periodSample and denominatorsUncertainty
        Sleep duration

        Sleep extension minus control

        Effect estimate

        1.2 hours/night

        reported between-group change difference

        Unit: hours/night

        Two intervention weeks following two baseline weeks

        Reported N: 80 — total randomized trial sample; not a group denominator

        • 80 — randomized total; scope: trial

        95% confidence interval: 1 to 1.4

        Reported p-value: <0.001 (Between-group comparison)

        Estimated energy intake

        Sleep extension minus control

        Effect estimate

        -270 kcal/day

        reported between-group change difference

        Unit: kcal/day

        Two intervention weeks following two baseline weeks

        Reported N: 80 — total randomized trial sample; not a group denominator

        • 80 — randomized total; scope: trial

        95% confidence interval: -393 to -147

        Reported p-value: <0.001 (Between-group comparison)

        Sleep duration — Sleep extension minus control: extraction context
        Outcome role
        Not specified in the consulted scope
        Scale reference
        intervention_vs_control_change
        Estimand and analysis rules
        Name
        Not reported or not verified
        Analysis population
        Intention-to-treat, as described in the verified input
        formal estimand not extracted
        Yes
        Extraction location
        Original article abstract; intervention duration checked in PMC full text
        • N=80 is the trial total; arm sizes and effect-specific N were not extracted.
        Estimated energy intake — Sleep extension minus control: extraction context
        Outcome role
        Not specified in the consulted scope
        Scale reference
        intervention_vs_control_change
        Estimand and analysis rules
        Name
        Not reported or not verified
        Analysis population
        Intention-to-treat, as described in the verified input
        formal estimand not extracted
        Yes
        Extraction location
        Original article abstract; intervention duration checked in PMC full text
        • N=80 is the trial total; arm sizes and effect-specific N were not extracted.

        What the curated evidence supports

        • In Tasali's trial involving 80 adults with overweight and short sleep, two weeks of sleep extension produced a −270 kcal/day difference in the change in estimated energy intake relative to control (95% CI −393 to −147).
        • In the same trial, the difference in sleep duration was 1.2 hours per night in favor of the intervention (95% CI 1.0–1.4).
        • Weight results during 68 or 72 treatment weeks and a two-week sleep intervention answer different questions from a withdrawal comparison after initial treatment. SURMOUNT-4 provides that specific comparison for 52 weeks after randomization.

        Limitations

        • 80 adults aged 21–40 with overweight and habitual sleep shorter than 6.5 hours; single center.
        • Two intervention weeks do not establish sustained weight-loss maintenance.
        • Intake was estimated from energy balance, not measured by directly counting food.

        Verification scope

        Verified through 2026-11-04 within the consulted scope.

        Bibliographic metadata checked
        Yes
        Original article abstract consulted
        Yes
        Full-text consultation
        selected_fields_only
        full text verified fields
        • intervention_duration
        • pmcid_linkage
        Official trial registry consulted
        No
        Statistical analysis plan consulted
        No
        Verification boundary
        Verification is limited to the input's identified abstract/full-text fields. A trial identifier linked by an article does not imply a separate registry review.

        Source record

        Effect of Sleep Extension on Objectively Assessed Energy Intake Among Adults With Overweight in Real-life Settings: A Randomized Clinical Trial (2022)

        Evidence review

        Sleep and emotional eating: a review of associations

        The Zeron-Rugerio review brings together studies of sleep and emotional eating and supports discussion of their association; the selected evidence does not establish that either causes the other.

        Evidence design
        Systematic review of observational and interventional studies
        Population
        Populations from studies on sleep, eating behavior and obesity; this does not represent a single clinical population.

        Keep in view

        • Association does not establish causal direction or an individual's response.
        • No pooled magnitude, CI or effect-specific denominator was verified for this card.
        See study details — Sleep and emotional eating review

        Review design and extraction scope

        Systematic review of observational and interventional studies

        Systematic review of cross-sectional, longitudinal and intervention studies; searches in Medline and Scopus, from January 2011 to December 2022.

        Population

        Populations from studies on sleep, eating behavior and obesity; this does not represent a single clinical population.

        Study design
        Systematic review of cross-sectional, longitudinal and intervention studies; searches in Medline and Scopus, from January 2011 to December 2022.
        Reported sample count
        Not reported or not verified
        Role of the reported sample count
        Review-wide total; not an outcome-specific denominator
        Included study count
        Not reported or not verified
        Role of the study count
        Review-wide total; not an outcome-specific denominator
        Research question
        Can emotional eating and disinhibition help explain the association between inadequate sleep and obesity?
        Qualified findings
        The review identifies associations of inadequate sleep with emotional eating and disinhibition, particularly among women. The authors propose these behaviors as possible links in the sleep–obesity relationship; the synthesis does not establish universal causal mediation or the efficacy of a specific intervention.
        Estimand and analysis rules
        Not reported or not verified
        Reason the formal estimand is unavailable
        A complete formal estimand was not extracted from the verified input.

        How to read this review

        Included studies may differ in population, design and outcomes. Review-wide counts describe coverage and cannot be used as the sample size of every estimate.

        What the curated evidence supports

        • The Zeron-Rugerio review brings together studies of sleep and emotional eating and supports discussion of their association; the selected evidence does not establish that either causes the other.

        Limitations

        • Association does not establish causal direction or an individual's response.
        • No pooled magnitude, CI or effect-specific denominator was verified for this card.

        Verification scope

        Verified through 2026-11-04 within the consulted scope.

        Bibliographic metadata checked
        Yes
        Original article abstract consulted
        Yes
        Full-text consultation
        Not consulted
        full text verified fields
          Official trial registry consulted
          No
          Statistical analysis plan consulted
          No
          Verification boundary
          Verification is limited to the input's identified abstract/full-text fields. A trial identifier linked by an article does not imply a separate registry review.

          Source record

          Are Emotional Eating and Other Eating Behaviors the Missing Link in the Relationship between Inadequate Sleep and Obesity? A Systematic Review (2023)

          THE RESEARCH LANDSCAPE

          Explore the research landscape

          See the scale of the consolidated catalog, the prioritized registry cohort, and the smaller set of evidence cards published in this release.

          46,042

          Consolidated research records

          112,151

          Mapped files

          16

          Scientific catalog areas

          Explore all 16 scientific areas
          Clinical obesity and overweight14,981
          GLP-1, GIP and incretin medicines2,081
          Insulin resistance and glycemic health6,298
          Calorie deficit and energy balance580
          Thermogenesis and energy expenditure461
          Fat oxidation and ketosis74
          Intermittent fasting and chrononutrition621
          Nutrition, eating and satiety5,932
          Muscle preservation and body composition3,735
          Gut microbiome and metabolomics607
          Physical activity and exercise3,696
          Sleep, stress and eating behavior1,358
          Weight maintenance and regain164
          Bariatric and metabolic surgery2,383
          Digital technologies and remote interventions585
          Cardiovascular, liver and inflammatory outcomes2,486

          Catalog identities consolidate DOI, NCT, PMID, PMCID and normalized titles; the count is not a certified count of independent peer-reviewed publications.

          Prioritized clinical registry records

          570 records
          Weight as a primary outcome
          342
          BMI as a primary outcome
          112
          Adiposity or waist as a primary outcome
          49
          Weight-related outcomes only as secondary outcomes
          29
          No direct weight-related outcome identified
          38

          Each record has one principal outcome class. This classification does not mean that a trial has only one outcome or that its findings have passed full scientific appraisal.

          PUBLISHED CURATED EVIDENCE

          13evidence cards

          Directed selection of sources and claims verified within the fields and sections actually consulted.

          60 result records23 reviewed claims
          Search covers these 13 published evidence cards.

          Catalog size and metadata completeness do not grade scientific certainty. The 570-record panorama describes a prioritized registry cohort, not 570 publicly reviewed evidence cards.

          THE INAUGURAL BRIEFING

          Video in preparation

          Muscle, Strength & Weight Loss: What Does DXA Measure?

          Planned inaugural nuViteo YouTube briefing on DXA lean mass, skeletal muscle, and strength, grounded in the SURMOUNT-1 substudy and EWGSOP2 evidence.

          Read the briefing outline

          OVERVIEW + STUDY DETAILS

          Sources supporting the briefing.

          Start with the finding and its limits.
          Open the study details to look closer.

          Conceptual consensus

          EWGSOP2: sarcopenia definition and assessment

          In this analysis, DXA lean mass is fat-free mass minus bone mineral content. It includes tissues other than muscle and, alone, does not describe strength or diagnose sarcopenia.

          Under EWGSOP2, low strength indicates probable sarcopenia; low muscle quantity or quality confirms the diagnosis, and low physical performance together with the other criteria identifies severe sarcopenia.

          Evidence design
          Diagnostic consensus concept

          Keep in view

          • Diagnostic consensus; it does not estimate a treatment effect or individual risk.
          • A decrease in total DXA lean mass alone does not diagnose sarcopenia.
          See study details — EWGSOP2

          Definitions and assessment framework

          Diagnostic consensus concept

          Expert consensus updating the European definition and diagnostic approach to sarcopenia; not an intervention trial.

          Diagnostic concepts
          • Diagnostic state
            Probable sarcopenia
            Definition
            Low muscle strength identifies probable sarcopenia.
          • Diagnostic state
            Confirmed sarcopenia
            Definition
            Low muscle quantity or quality confirms the diagnosis in the presence of low strength.
          • Diagnostic state
            Severe sarcopenia
            Definition
            Low strength, low muscle quantity/quality and low physical performance together identify severe sarcopenia.
          Assessment sequence
          • Find cases
          • Assess muscle strength
          • Confirm muscle quantity or quality
          • Determine severity with physical performance

          What the curated evidence supports

          • In this analysis, DXA lean mass is fat-free mass minus bone mineral content. It includes tissues other than muscle and, alone, does not describe strength or diagnose sarcopenia.
          • Under EWGSOP2, low strength indicates probable sarcopenia; low muscle quantity or quality confirms the diagnosis, and low physical performance together with the other criteria identifies severe sarcopenia.

          Limitations

          • Diagnostic consensus; it does not estimate a treatment effect or individual risk.
          • A decrease in total DXA lean mass alone does not diagnose sarcopenia.

          Verification scope

          Verified through 2026-11-04 within the consulted scope.

          Bibliographic metadata checked
          Yes
          Original article abstract consulted
          Yes
          Full-text consultation
          Consulted
          Official trial registry consulted
          No
          Statistical analysis plan consulted
          No
          Verification boundary
          Verification is limited to the specific fields and sources consulted; it is not a full systematic appraisal or GRADE rating.

          Source record

          Sarcopenia: revised European consensus on definition and diagnosis (2019). Age and ageing.

          Controlled study

          SURMOUNT-1 DXA: weight, fat and lean soft tissue at 72 weeks

          The DXA substudy analyzed 160 participants: 124 receiving pooled tirzepatide doses and 36 receiving placebo. At 72 weeks, changes in weight, fat and lean mass were −21.3%, −33.9% and −10.9% with tirzepatide, versus −5.3%, −8.2% and −2.6% with placebo.

          In this analysis, DXA lean mass is fat-free mass minus bone mineral content. It includes tissues other than muscle and, alone, does not describe strength or diagnose sarcopenia.

          The article describes roughly three quarters of combined fat and lean mass losses as fat. This sample-level composition does not justify saying that one quarter of lost weight was skeletal muscle.

          Evidence design
          Randomized trial substudy
          Population
          Subset of SURMOUNT-1 adults with obesity or overweight and a weight-related complication, without type 2 diabetes; 73.1% female; mean age 46.2 years, weight 102.5 kg and BMI 38.0 kg/m2.
          Assessment period
          Baseline to week 72
          Reported units
          percentage points; % change; % of combined fat and lean mass loss; kg

          Keep in view

          • 160 of 255 substudy enrollees were analyzed; 5, 10 and 15 mg doses were pooled.
          • DXA lean mass does not directly measure skeletal muscle or strength.
          • There was no multiplicity adjustment; missing data from three participants used last observation carried forward.
          See study details — SURMOUNT-1 DXA

          Study design and methods

          Randomized trial substudy

          Prespecified DXA body-composition substudy nested within randomized SURMOUNT-1; pooled tirzepatide doses; additional post hoc subgroup analyses.

          Population

          Subset of SURMOUNT-1 adults with obesity or overweight and a weight-related complication, without type 2 diabetes; 73.1% female; mean age 46.2 years, weight 102.5 kg and BMI 38.0 kg/m2.

          Assessment period
          Value
          72
          Unit
          weeks
          Parent trial randomized participants
          2539
          Substudy enrollees
          255
          Substudy analyzed participants
          160
          Analyzed participants by arm
          Tirzepatide, pooled doses
          124
          Placebo
          36
          Analysis denominator basis
          Participants in the substudy who were randomized, received >=1 dose and had nonmissing baseline and postbaseline DXA measurements. Of 255 enrolled, 160 completed baseline and week-72 or early-discontinuation scans and were included.
          Dose pooling
          5, 10 and 15 mg tirzepatide pooled; these results cannot be relabeled as a 15-mg-only effect.
          Measurement definition
          Measurement method
          Whole-body dual-energy X-ray absorptiometry (DXA)
          Measurement timing
          Baseline before first dose and end of treatment at week 72 (within 14 days) or early discontinuation.
          DXA lean mass definition
          DXA lean mass = fat-free mass minus total bone mineral content. It is lean soft tissue, not a direct skeletal-muscle measurement.
          Fat-free mass definition
          Includes nonfat tissues such as muscle, bone, organs, ligaments, tendons and water; fat-free mass itself was not the reported endpoint.
          Skeletal muscle measured directly
          No
          Direct strength or physical-performance outcome in this card
          No
          Statistical analysis
          Analysis population label in the figure
          Modified intention-to-treat population (efficacy analysis set)
          Statistical model
          ANCOVA for body weight, fat and lean measures: baseline response covariate and treatment factor; waist used MMRM.
          Missing-data handling
          Three missing week-72 observations imputed by last observation carried forward.
          Multiplicity adjustment
          No
          Formal estimand specification
          Efficacy analysis set; a separate, fully specified five-attribute estimand was not verified in the substudy full text.
          Parent-trial estimand must not be inherited without qualification
          Yes

          Extracted outcomes

          Reported values, analysis populations and uncertainty, preserved from the curated extraction.
          Outcome and groupReported valueAssessment periodSample and denominatorsUncertainty
          Percent change in body weight

          Tirzepatide pooled 5/10/15 mg

          Effect estimate

          -21.3 % change

          least-squares mean

          Unit: % change

          Baseline to week 72

          Study weeks 0–72

          Reported N: 124 — substudy analysis population

          • 2539 — parent trial randomized total; scope: parent trial
          • 255 — substudy enrolled; scope: DXA substudy
          • 160 — substudy analyzed; scope: DXA substudy
          • 124 — substudy analysis arm; scope: Tirzepatide, pooled doses

          Arm confidence interval not verified; no reconstruction was performed.

          Percent change in body weight

          Placebo

          Effect estimate

          -5.3 % change

          least-squares mean

          Unit: % change

          Baseline to week 72

          Study weeks 0–72

          Reported N: 36 — substudy analysis population

          • 2539 — parent trial randomized total; scope: parent trial
          • 255 — substudy enrolled; scope: DXA substudy
          • 160 — substudy analyzed; scope: DXA substudy
          • 36 — substudy analysis arm; scope: Placebo

          Arm confidence interval not verified; no reconstruction was performed.

          Percent change in body weight

          Pooled tirzepatide minus placebo

          Effect estimate

          -16 percentage points

          adjusted mean difference

          Unit: percentage points

          Baseline to week 72

          Study weeks 0–72

          Reported N: 160 — combined substudy analysis population

          • 2539 — parent trial randomized total; scope: parent trial
          • 255 — substudy enrolled; scope: DXA substudy
          • 160 — substudy analyzed; scope: DXA substudy

          95% confidence interval: -19.4 to -12.6

          Reported p-value: <0.001 (between group comparison no multiplicity adjustment)

          Percent change in fat mass

          Tirzepatide pooled 5/10/15 mg

          Effect estimate

          -33.9 % change

          least-squares mean

          Unit: % change

          Baseline to week 72

          Study weeks 0–72

          Reported N: 124 — substudy analysis population

          • 2539 — parent trial randomized total; scope: parent trial
          • 255 — substudy enrolled; scope: DXA substudy
          • 160 — substudy analyzed; scope: DXA substudy
          • 124 — substudy analysis arm; scope: Tirzepatide, pooled doses

          Arm confidence interval not verified; no reconstruction was performed.

          Percent change in fat mass

          Placebo

          Effect estimate

          -8.2 % change

          least-squares mean

          Unit: % change

          Baseline to week 72

          Study weeks 0–72

          Reported N: 36 — substudy analysis population

          • 2539 — parent trial randomized total; scope: parent trial
          • 255 — substudy enrolled; scope: DXA substudy
          • 160 — substudy analyzed; scope: DXA substudy
          • 36 — substudy analysis arm; scope: Placebo

          Arm confidence interval not verified; no reconstruction was performed.

          Percent change in fat mass

          Pooled tirzepatide minus placebo

          Effect estimate

          -25.7 percentage points

          adjusted mean difference

          Unit: percentage points

          Baseline to week 72

          Study weeks 0–72

          Reported N: 160 — combined substudy analysis population

          • 2539 — parent trial randomized total; scope: parent trial
          • 255 — substudy enrolled; scope: DXA substudy
          • 160 — substudy analyzed; scope: DXA substudy

          95% confidence interval: -31.4 to -20

          Reported p-value: <0.001 (between group comparison no multiplicity adjustment)

          Percent change in DXA lean soft tissue mass

          Tirzepatide pooled 5/10/15 mg

          Effect estimate

          -10.9 % change

          least-squares mean

          Unit: % change

          Baseline to week 72

          Study weeks 0–72

          Reported N: 124 — substudy analysis population

          • 2539 — parent trial randomized total; scope: parent trial
          • 255 — substudy enrolled; scope: DXA substudy
          • 160 — substudy analyzed; scope: DXA substudy
          • 124 — substudy analysis arm; scope: Tirzepatide, pooled doses

          Arm confidence interval not verified; no reconstruction was performed.

          Percent change in DXA lean soft tissue mass

          Placebo

          Effect estimate

          -2.6 % change

          least-squares mean

          Unit: % change

          Baseline to week 72

          Study weeks 0–72

          Reported N: 36 — substudy analysis population

          • 2539 — parent trial randomized total; scope: parent trial
          • 255 — substudy enrolled; scope: DXA substudy
          • 160 — substudy analyzed; scope: DXA substudy
          • 36 — substudy analysis arm; scope: Placebo

          Arm confidence interval not verified; no reconstruction was performed.

          Percent change in DXA lean soft tissue mass

          Pooled tirzepatide minus placebo

          Effect estimate

          -8.3 percentage points

          adjusted mean difference

          Unit: percentage points

          Baseline to week 72

          Study weeks 0–72

          Reported N: 160 — combined substudy analysis population

          • 2539 — parent trial randomized total; scope: parent trial
          • 255 — substudy enrolled; scope: DXA substudy
          • 160 — substudy analyzed; scope: DXA substudy

          95% confidence interval: -10.6 to -6.1

          Reported p-value: <0.001 (between group comparison no multiplicity adjustment)

          Absolute change in fat mass

          Tirzepatide pooled 5/10/15 mg

          Effect estimate

          -15.9 kg

          least-squares mean

          Unit: kg

          Baseline to week 72

          Study weeks 0–72

          Reported N: 124 — substudy analysis population

          • 2539 — parent trial randomized total; scope: parent trial
          • 255 — substudy enrolled; scope: DXA substudy
          • 160 — substudy analyzed; scope: DXA substudy
          • 124 — substudy analysis arm; scope: Tirzepatide, pooled doses

          Arm confidence interval not verified; no reconstruction was performed.

          Absolute change in fat mass

          Placebo

          Effect estimate

          -3.6 kg

          least-squares mean

          Unit: kg

          Baseline to week 72

          Study weeks 0–72

          Reported N: 36 — substudy analysis population

          • 2539 — parent trial randomized total; scope: parent trial
          • 255 — substudy enrolled; scope: DXA substudy
          • 160 — substudy analyzed; scope: DXA substudy
          • 36 — substudy analysis arm; scope: Placebo

          Arm confidence interval not verified; no reconstruction was performed.

          Absolute change in fat mass

          Pooled tirzepatide minus placebo

          Effect estimate

          -12.3 kg

          adjusted mean difference

          Unit: kg

          Baseline to week 72

          Study weeks 0–72

          Reported N: 160 — combined substudy analysis population

          • 2539 — parent trial randomized total; scope: parent trial
          • 255 — substudy enrolled; scope: DXA substudy
          • 160 — substudy analyzed; scope: DXA substudy

          95% confidence interval: -15.1 to -9.6

          Reported p-value: <0.001 (between group comparison no multiplicity adjustment)

          Absolute change in DXA lean soft tissue mass

          Tirzepatide pooled 5/10/15 mg

          Effect estimate

          -5.6 kg

          least-squares mean

          Unit: kg

          Baseline to week 72

          Study weeks 0–72

          Reported N: 124 — substudy analysis population

          • 2539 — parent trial randomized total; scope: parent trial
          • 255 — substudy enrolled; scope: DXA substudy
          • 160 — substudy analyzed; scope: DXA substudy
          • 124 — substudy analysis arm; scope: Tirzepatide, pooled doses

          Arm confidence interval not verified; no reconstruction was performed.

          Absolute change in DXA lean soft tissue mass

          Placebo

          Effect estimate

          -1.2 kg

          least-squares mean

          Unit: kg

          Baseline to week 72

          Study weeks 0–72

          Reported N: 36 — substudy analysis population

          • 2539 — parent trial randomized total; scope: parent trial
          • 255 — substudy enrolled; scope: DXA substudy
          • 160 — substudy analyzed; scope: DXA substudy
          • 36 — substudy analysis arm; scope: Placebo

          Arm confidence interval not verified; no reconstruction was performed.

          Absolute change in DXA lean soft tissue mass

          Pooled tirzepatide minus placebo

          Effect estimate

          -4.4 kg

          adjusted mean difference

          Unit: kg

          Baseline to week 72

          Study weeks 0–72

          Reported N: 160 — combined substudy analysis population

          • 2539 — parent trial randomized total; scope: parent trial
          • 255 — substudy enrolled; scope: DXA substudy
          • 160 — substudy analyzed; scope: DXA substudy

          95% confidence interval: -5.6 to -3.2

          Reported p-value: <0.001 (between group comparison no multiplicity adjustment)

          Fat fraction of combined fat and lean mass losses

          Pooled tirzepatide

          Descriptive result; not an effect estimate

          74 % of combined fat and lean mass loss

          reported proportion

          Unit: % of combined fat and lean mass loss

          Baseline to week 72

          Study weeks 0–72

          Reported N: 124 — substudy analysis population

          • 2539 — parent trial randomized total; scope: parent trial
          • 255 — substudy enrolled; scope: DXA substudy
          • 160 — substudy analyzed; scope: DXA substudy

          Confidence interval for the fraction not verified.

          Lean soft tissue fraction of combined fat and lean mass losses

          Pooled tirzepatide

          Descriptive result; not an effect estimate

          26 % of combined fat and lean mass loss

          reported proportion

          Unit: % of combined fat and lean mass loss

          Baseline to week 72

          Study weeks 0–72

          Reported N: 124 — substudy analysis population

          • 2539 — parent trial randomized total; scope: parent trial
          • 255 — substudy enrolled; scope: DXA substudy
          • 160 — substudy analyzed; scope: DXA substudy

          Confidence interval for the fraction not verified.

          Fat fraction of combined fat and lean mass losses

          Placebo

          Descriptive result; not an effect estimate

          75 % of combined fat and lean mass loss

          reported proportion

          Unit: % of combined fat and lean mass loss

          Baseline to week 72

          Study weeks 0–72

          Reported N: 36 — substudy analysis population

          • 2539 — parent trial randomized total; scope: parent trial
          • 255 — substudy enrolled; scope: DXA substudy
          • 160 — substudy analyzed; scope: DXA substudy

          Confidence interval for the fraction not verified.

          Lean soft tissue fraction of combined fat and lean mass losses

          Placebo

          Descriptive result; not an effect estimate

          25 % of combined fat and lean mass loss

          reported proportion

          Unit: % of combined fat and lean mass loss

          Baseline to week 72

          Study weeks 0–72

          Reported N: 36 — substudy analysis population

          • 2539 — parent trial randomized total; scope: parent trial
          • 255 — substudy enrolled; scope: DXA substudy
          • 160 — substudy analyzed; scope: DXA substudy

          Confidence interval for the fraction not verified.

          Percent change in body weight — Tirzepatide pooled 5/10/15 mg: extraction context
          Outcome role
          Exploratory, post hoc
          Scale reference
          Baseline value of the same tissue or weight
          Estimand and analysis rules
          Name
          Not reported or not verified
          Analysis set
          Modified intention-to-treat population (efficacy analysis set)
          Definition verification status
          Full formal estimand not verified; do not inherit the parent-trial treatment-regimen estimand.
          Statistical analysis
          Analysis population label in the figure
          Modified intention-to-treat population (efficacy analysis set)
          Statistical model
          ANCOVA for body weight, fat and lean measures: baseline response covariate and treatment factor; waist used MMRM.
          Missing-data handling
          Three missing week-72 observations imputed by last observation carried forward.
          Multiplicity adjustment
          No
          Formal estimand specification
          Efficacy analysis set; a separate, fully specified five-attribute estimand was not verified in the substudy full text.
          Parent-trial estimand must not be inherited without qualification
          Yes
          Extraction location
          Full text section 3.2; Figure 1 or supplementary Figure S2
          Percent change in body weight — Placebo: extraction context
          Outcome role
          Exploratory, post hoc
          Scale reference
          Baseline value of the same tissue or weight
          Estimand and analysis rules
          Name
          Not reported or not verified
          Analysis set
          Modified intention-to-treat population (efficacy analysis set)
          Definition verification status
          Full formal estimand not verified; do not inherit the parent-trial treatment-regimen estimand.
          Statistical analysis
          Analysis population label in the figure
          Modified intention-to-treat population (efficacy analysis set)
          Statistical model
          ANCOVA for body weight, fat and lean measures: baseline response covariate and treatment factor; waist used MMRM.
          Missing-data handling
          Three missing week-72 observations imputed by last observation carried forward.
          Multiplicity adjustment
          No
          Formal estimand specification
          Efficacy analysis set; a separate, fully specified five-attribute estimand was not verified in the substudy full text.
          Parent-trial estimand must not be inherited without qualification
          Yes
          Extraction location
          Full text section 3.2; Figure 1 or supplementary Figure S2
          Percent change in body weight — Pooled tirzepatide minus placebo: extraction context
          Outcome role
          Exploratory, post hoc
          Scale reference
          Difference in percent change
          Estimand and analysis rules
          Name
          Not reported or not verified
          Analysis set
          Modified intention-to-treat population (efficacy analysis set)
          Definition verification status
          Full formal estimand not verified; do not inherit the parent-trial treatment-regimen estimand.
          Statistical analysis
          Analysis population label in the figure
          Modified intention-to-treat population (efficacy analysis set)
          Statistical model
          ANCOVA for body weight, fat and lean measures: baseline response covariate and treatment factor; waist used MMRM.
          Missing-data handling
          Three missing week-72 observations imputed by last observation carried forward.
          Multiplicity adjustment
          No
          Formal estimand specification
          Efficacy analysis set; a separate, fully specified five-attribute estimand was not verified in the substudy full text.
          Parent-trial estimand must not be inherited without qualification
          Yes
          Extraction location
          Full text section 3.2
          • No multiplicity adjustment.
          Percent change in fat mass — Tirzepatide pooled 5/10/15 mg: extraction context
          Outcome role
          primary_substudy_objective
          Scale reference
          Baseline value of the same tissue or weight
          Estimand and analysis rules
          Name
          Not reported or not verified
          Analysis set
          Modified intention-to-treat population (efficacy analysis set)
          Definition verification status
          Full formal estimand not verified; do not inherit the parent-trial treatment-regimen estimand.
          Statistical analysis
          Analysis population label in the figure
          Modified intention-to-treat population (efficacy analysis set)
          Statistical model
          ANCOVA for body weight, fat and lean measures: baseline response covariate and treatment factor; waist used MMRM.
          Missing-data handling
          Three missing week-72 observations imputed by last observation carried forward.
          Multiplicity adjustment
          No
          Formal estimand specification
          Efficacy analysis set; a separate, fully specified five-attribute estimand was not verified in the substudy full text.
          Parent-trial estimand must not be inherited without qualification
          Yes
          Extraction location
          Full text section 3.2; Figure 1 or supplementary Figure S2
          Percent change in fat mass — Placebo: extraction context
          Outcome role
          primary_substudy_objective
          Scale reference
          Baseline value of the same tissue or weight
          Estimand and analysis rules
          Name
          Not reported or not verified
          Analysis set
          Modified intention-to-treat population (efficacy analysis set)
          Definition verification status
          Full formal estimand not verified; do not inherit the parent-trial treatment-regimen estimand.
          Statistical analysis
          Analysis population label in the figure
          Modified intention-to-treat population (efficacy analysis set)
          Statistical model
          ANCOVA for body weight, fat and lean measures: baseline response covariate and treatment factor; waist used MMRM.
          Missing-data handling
          Three missing week-72 observations imputed by last observation carried forward.
          Multiplicity adjustment
          No
          Formal estimand specification
          Efficacy analysis set; a separate, fully specified five-attribute estimand was not verified in the substudy full text.
          Parent-trial estimand must not be inherited without qualification
          Yes
          Extraction location
          Full text section 3.2; Figure 1 or supplementary Figure S2
          Percent change in fat mass — Pooled tirzepatide minus placebo: extraction context
          Outcome role
          primary_substudy_objective
          Scale reference
          Difference in percent change
          Estimand and analysis rules
          Name
          Not reported or not verified
          Analysis set
          Modified intention-to-treat population (efficacy analysis set)
          Definition verification status
          Full formal estimand not verified; do not inherit the parent-trial treatment-regimen estimand.
          Statistical analysis
          Analysis population label in the figure
          Modified intention-to-treat population (efficacy analysis set)
          Statistical model
          ANCOVA for body weight, fat and lean measures: baseline response covariate and treatment factor; waist used MMRM.
          Missing-data handling
          Three missing week-72 observations imputed by last observation carried forward.
          Multiplicity adjustment
          No
          Formal estimand specification
          Efficacy analysis set; a separate, fully specified five-attribute estimand was not verified in the substudy full text.
          Parent-trial estimand must not be inherited without qualification
          Yes
          Extraction location
          Full text section 3.2
          • No multiplicity adjustment.
          Percent change in DXA lean soft tissue mass — Tirzepatide pooled 5/10/15 mg: extraction context
          Outcome role
          secondary
          Scale reference
          Baseline value of the same tissue or weight
          Estimand and analysis rules
          Name
          Not reported or not verified
          Analysis set
          Modified intention-to-treat population (efficacy analysis set)
          Definition verification status
          Full formal estimand not verified; do not inherit the parent-trial treatment-regimen estimand.
          Statistical analysis
          Analysis population label in the figure
          Modified intention-to-treat population (efficacy analysis set)
          Statistical model
          ANCOVA for body weight, fat and lean measures: baseline response covariate and treatment factor; waist used MMRM.
          Missing-data handling
          Three missing week-72 observations imputed by last observation carried forward.
          Multiplicity adjustment
          No
          Formal estimand specification
          Efficacy analysis set; a separate, fully specified five-attribute estimand was not verified in the substudy full text.
          Parent-trial estimand must not be inherited without qualification
          Yes
          Extraction location
          Full text section 3.2; Figure 1 or supplementary Figure S2
          • Lean mass means lean soft tissue excluding bone mineral content; it is not skeletal muscle mass.
          Percent change in DXA lean soft tissue mass — Placebo: extraction context
          Outcome role
          secondary
          Scale reference
          Baseline value of the same tissue or weight
          Estimand and analysis rules
          Name
          Not reported or not verified
          Analysis set
          Modified intention-to-treat population (efficacy analysis set)
          Definition verification status
          Full formal estimand not verified; do not inherit the parent-trial treatment-regimen estimand.
          Statistical analysis
          Analysis population label in the figure
          Modified intention-to-treat population (efficacy analysis set)
          Statistical model
          ANCOVA for body weight, fat and lean measures: baseline response covariate and treatment factor; waist used MMRM.
          Missing-data handling
          Three missing week-72 observations imputed by last observation carried forward.
          Multiplicity adjustment
          No
          Formal estimand specification
          Efficacy analysis set; a separate, fully specified five-attribute estimand was not verified in the substudy full text.
          Parent-trial estimand must not be inherited without qualification
          Yes
          Extraction location
          Full text section 3.2; Figure 1 or supplementary Figure S2
          • Lean mass means lean soft tissue excluding bone mineral content; it is not skeletal muscle mass.
          Percent change in DXA lean soft tissue mass — Pooled tirzepatide minus placebo: extraction context
          Outcome role
          secondary
          Scale reference
          Difference in percent change
          Estimand and analysis rules
          Name
          Not reported or not verified
          Analysis set
          Modified intention-to-treat population (efficacy analysis set)
          Definition verification status
          Full formal estimand not verified; do not inherit the parent-trial treatment-regimen estimand.
          Statistical analysis
          Analysis population label in the figure
          Modified intention-to-treat population (efficacy analysis set)
          Statistical model
          ANCOVA for body weight, fat and lean measures: baseline response covariate and treatment factor; waist used MMRM.
          Missing-data handling
          Three missing week-72 observations imputed by last observation carried forward.
          Multiplicity adjustment
          No
          Formal estimand specification
          Efficacy analysis set; a separate, fully specified five-attribute estimand was not verified in the substudy full text.
          Parent-trial estimand must not be inherited without qualification
          Yes
          Extraction location
          Full text section 3.2
          • No multiplicity adjustment.
          Absolute change in fat mass — Tirzepatide pooled 5/10/15 mg: extraction context
          Outcome role
          secondary
          Scale reference
          absolute_change
          Estimand and analysis rules
          Name
          Not reported or not verified
          Analysis set
          Modified intention-to-treat population (efficacy analysis set)
          Definition verification status
          Full formal estimand not verified; do not inherit the parent-trial treatment-regimen estimand.
          Statistical analysis
          Analysis population label in the figure
          Modified intention-to-treat population (efficacy analysis set)
          Statistical model
          ANCOVA for body weight, fat and lean measures: baseline response covariate and treatment factor; waist used MMRM.
          Missing-data handling
          Three missing week-72 observations imputed by last observation carried forward.
          Multiplicity adjustment
          No
          Formal estimand specification
          Efficacy analysis set; a separate, fully specified five-attribute estimand was not verified in the substudy full text.
          Parent-trial estimand must not be inherited without qualification
          Yes
          Extraction location
          Full text section 3.2; Figure 1 or supplementary Figure S2
          Absolute change in fat mass — Placebo: extraction context
          Outcome role
          secondary
          Scale reference
          absolute_change
          Estimand and analysis rules
          Name
          Not reported or not verified
          Analysis set
          Modified intention-to-treat population (efficacy analysis set)
          Definition verification status
          Full formal estimand not verified; do not inherit the parent-trial treatment-regimen estimand.
          Statistical analysis
          Analysis population label in the figure
          Modified intention-to-treat population (efficacy analysis set)
          Statistical model
          ANCOVA for body weight, fat and lean measures: baseline response covariate and treatment factor; waist used MMRM.
          Missing-data handling
          Three missing week-72 observations imputed by last observation carried forward.
          Multiplicity adjustment
          No
          Formal estimand specification
          Efficacy analysis set; a separate, fully specified five-attribute estimand was not verified in the substudy full text.
          Parent-trial estimand must not be inherited without qualification
          Yes
          Extraction location
          Full text section 3.2; Figure 1 or supplementary Figure S2
          Absolute change in fat mass — Pooled tirzepatide minus placebo: extraction context
          Outcome role
          secondary
          Scale reference
          absolute_difference
          Estimand and analysis rules
          Name
          Not reported or not verified
          Analysis set
          Modified intention-to-treat population (efficacy analysis set)
          Definition verification status
          Full formal estimand not verified; do not inherit the parent-trial treatment-regimen estimand.
          Statistical analysis
          Analysis population label in the figure
          Modified intention-to-treat population (efficacy analysis set)
          Statistical model
          ANCOVA for body weight, fat and lean measures: baseline response covariate and treatment factor; waist used MMRM.
          Missing-data handling
          Three missing week-72 observations imputed by last observation carried forward.
          Multiplicity adjustment
          No
          Formal estimand specification
          Efficacy analysis set; a separate, fully specified five-attribute estimand was not verified in the substudy full text.
          Parent-trial estimand must not be inherited without qualification
          Yes
          Extraction location
          Full text section 3.2
          • No multiplicity adjustment.
          Absolute change in DXA lean soft tissue mass — Tirzepatide pooled 5/10/15 mg: extraction context
          Outcome role
          secondary
          Scale reference
          absolute_change
          Estimand and analysis rules
          Name
          Not reported or not verified
          Analysis set
          Modified intention-to-treat population (efficacy analysis set)
          Definition verification status
          Full formal estimand not verified; do not inherit the parent-trial treatment-regimen estimand.
          Statistical analysis
          Analysis population label in the figure
          Modified intention-to-treat population (efficacy analysis set)
          Statistical model
          ANCOVA for body weight, fat and lean measures: baseline response covariate and treatment factor; waist used MMRM.
          Missing-data handling
          Three missing week-72 observations imputed by last observation carried forward.
          Multiplicity adjustment
          No
          Formal estimand specification
          Efficacy analysis set; a separate, fully specified five-attribute estimand was not verified in the substudy full text.
          Parent-trial estimand must not be inherited without qualification
          Yes
          Extraction location
          Full text section 3.2; Figure 1 or supplementary Figure S2
          • Lean mass means lean soft tissue excluding bone mineral content; it is not skeletal muscle mass.
          Absolute change in DXA lean soft tissue mass — Placebo: extraction context
          Outcome role
          secondary
          Scale reference
          absolute_change
          Estimand and analysis rules
          Name
          Not reported or not verified
          Analysis set
          Modified intention-to-treat population (efficacy analysis set)
          Definition verification status
          Full formal estimand not verified; do not inherit the parent-trial treatment-regimen estimand.
          Statistical analysis
          Analysis population label in the figure
          Modified intention-to-treat population (efficacy analysis set)
          Statistical model
          ANCOVA for body weight, fat and lean measures: baseline response covariate and treatment factor; waist used MMRM.
          Missing-data handling
          Three missing week-72 observations imputed by last observation carried forward.
          Multiplicity adjustment
          No
          Formal estimand specification
          Efficacy analysis set; a separate, fully specified five-attribute estimand was not verified in the substudy full text.
          Parent-trial estimand must not be inherited without qualification
          Yes
          Extraction location
          Full text section 3.2; Figure 1 or supplementary Figure S2
          • Lean mass means lean soft tissue excluding bone mineral content; it is not skeletal muscle mass.
          Absolute change in DXA lean soft tissue mass — Pooled tirzepatide minus placebo: extraction context
          Outcome role
          secondary
          Scale reference
          absolute_difference
          Estimand and analysis rules
          Name
          Not reported or not verified
          Analysis set
          Modified intention-to-treat population (efficacy analysis set)
          Definition verification status
          Full formal estimand not verified; do not inherit the parent-trial treatment-regimen estimand.
          Statistical analysis
          Analysis population label in the figure
          Modified intention-to-treat population (efficacy analysis set)
          Statistical model
          ANCOVA for body weight, fat and lean measures: baseline response covariate and treatment factor; waist used MMRM.
          Missing-data handling
          Three missing week-72 observations imputed by last observation carried forward.
          Multiplicity adjustment
          No
          Formal estimand specification
          Efficacy analysis set; a separate, fully specified five-attribute estimand was not verified in the substudy full text.
          Parent-trial estimand must not be inherited without qualification
          Yes
          Extraction location
          Full text section 3.2
          • No multiplicity adjustment.
          Fat fraction of combined fat and lean mass losses — Pooled tirzepatide: extraction context
          Outcome role
          Exploratory, post hoc
          Scale reference
          fat_loss_plus_lean_mass_loss
          Extraction location
          Full text Table 1 formula and section 3.2
          • Fraction of combined fat and lean mass losses; not a skeletal-muscle fraction or an individual prediction.
          Lean soft tissue fraction of combined fat and lean mass losses — Pooled tirzepatide: extraction context
          Outcome role
          Exploratory, post hoc
          Scale reference
          fat_loss_plus_lean_mass_loss
          Extraction location
          Full text Table 1 formula and section 3.2
          • Fraction of combined fat and lean mass losses; not a skeletal-muscle fraction or an individual prediction.
          Fat fraction of combined fat and lean mass losses — Placebo: extraction context
          Outcome role
          Exploratory, post hoc
          Scale reference
          fat_loss_plus_lean_mass_loss
          Extraction location
          Full text Table 1 formula and section 3.2
          • Fraction of combined fat and lean mass losses; not a skeletal-muscle fraction or an individual prediction.
          Lean soft tissue fraction of combined fat and lean mass losses — Placebo: extraction context
          Outcome role
          Exploratory, post hoc
          Scale reference
          fat_loss_plus_lean_mass_loss
          Extraction location
          Full text Table 1 formula and section 3.2
          • Fraction of combined fat and lean mass losses; not a skeletal-muscle fraction or an individual prediction.

          What the curated evidence supports

          • The DXA substudy analyzed 160 participants: 124 receiving pooled tirzepatide doses and 36 receiving placebo. At 72 weeks, changes in weight, fat and lean mass were −21.3%, −33.9% and −10.9% with tirzepatide, versus −5.3%, −8.2% and −2.6% with placebo.
          • In this analysis, DXA lean mass is fat-free mass minus bone mineral content. It includes tissues other than muscle and, alone, does not describe strength or diagnose sarcopenia.
          • The article describes roughly three quarters of combined fat and lean mass losses as fat. This sample-level composition does not justify saying that one quarter of lost weight was skeletal muscle.

          Limitations

          • 160 of 255 substudy enrollees were analyzed; 5, 10 and 15 mg doses were pooled.
          • DXA lean mass does not directly measure skeletal muscle or strength.
          • There was no multiplicity adjustment; missing data from three participants used last observation carried forward.

          Verification scope

          Verified through 2026-11-04 within the consulted scope.

          Bibliographic metadata checked
          Yes
          Original article abstract consulted
          Yes
          Full-text consultation
          Consulted
          Official trial registry consulted
          Yes
          Statistical analysis plan consulted
          No
          Verification boundary
          Verification is limited to the specific fields and sources consulted; it is not a full systematic appraisal or GRADE rating.

          Source record

          Body composition changes during weight reduction with tirzepatide in the SURMOUNT-1 study of adults with obesity or overweight (2025). Diabetes, obesity & metabolism.