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Study · Randomized controlled trial · n = 670 · 2025

4 results

Tirzepatide Associated With Improved Health-Related Quality of Life in Adults With Obesity or Overweight in SURMOUNT-4.

Gibble TH, Cao D, Murphy M, Jouravskaya I, Liao B, Bays HE

Obesity (Silver Spring, Md.)3 Sept 2025Cited by 4 (Europe PMC)

Summary

ObjectiveIn SURMOUNT-4, participants with obesity or overweight regained substantial weight after tirzepatide withdrawal, whereas continued treatment resulted in additional weight reduction. We evaluated the effect of continued tirzepatide treatment on health-related quality of life (HRQoL) in SURMOUNT-4.MethodsParticipants who achieved tirzepatide maximum tolerated dose (MTD; 10 or 15 mg; N = 670) during a 36-week (W) lead-in period were randomized (1:1) to continue receiving tirzepatide MTD or switch to placebo through W88. HRQoL was assessed using patient-reported outcomes (PROs: SF-36v2, IWQOL-Lite-CT, EQ-5D-5L). Post hoc analysis included changes in PROs by weight reduction categories and baseline Patient Global Impression of Status for physical activity response categories among tirzepatide-treated participants and by weight regain categories in the placebo group.ResultsTirzepatide treatment was associated with improved PROs from W0 to W36, and these improvements were maintained from W36 to W88 with continued tirzepatide treatment versus placebo. Tirzepatide-treated participants with greater weight reduction and those with physical function limitations at baseline showed numerically greater improvements in PROs. Greater weight regain among participants who switched to placebo was associated with worsening of PROs.ConclusionsIn participants with overweight or obesity, continued tirzepatide treatment was associated with maintaining HRQoL improvement, while treatment withdrawal resulted in worsening of HRQoL.Trial registrationClinicalTrials.gov identifier NCT04660643.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with obesity or overweight, tirzepatide treatment was associated with improved patient-reported health-related quality of life from week 0 to week 36.

    In plain wordsIn adults with obesity or overweight, quality-of-life scores improved during the first 36 weeks of tirzepatide.

    Outcome
    IncreasePatient-reported outcomes change from week 0 to week 36
    Study

    n = 670

    Outcome group
    Quality of life · Whole body
    Studied dose
    maximum tolerated dose (10 or 15 mg) · 36 weeksAs given in this study (human).

    Source sentences

    Summary
    Tirzepatide treatment was associated with improved PROs from W0 to W36, and these improvements were maintained from W36 to W88 with continued tirzepatide treatment versus placebo.
    2 context sentences
    Summary · context
    HRQoL was assessed using patient-reported outcomes (PROs: SF-36v2, IWQOL-Lite-CT, EQ-5D-5L).
    Summary · context
    Participants who achieved tirzepatide maximum tolerated dose (MTD; 10 or 15 mg; N = 670) during a 36-week (W) lead-in period were randomized (1:1) to continue receiving tirzepatide MTD or switch to placebo through W88.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with obesity or overweight, continued tirzepatide maintained the quality-of-life improvements from week 36 to week 88 compared with switching to placebo.

    In plain wordsIn adults with obesity or overweight, continuing tirzepatide kept quality-of-life gains up to week 88, compared with switching to placebo.

    Outcome
    IncreasePatient-reported outcomes maintained from week 36 to week 88
    Study

    n = 670

    Comparator
    Placebo
    Outcome group
    Quality of life · Whole body
    Studied dose
    maximum tolerated dose (10 or 15 mg) · 88 weeksAs given in this study (human).

    Source sentences

    Summary
    these improvements were maintained from W36 to W88 with continued tirzepatide treatment versus placebo.
    2 context sentences
    Summary · context
    HRQoL was assessed using patient-reported outcomes (PROs: SF-36v2, IWQOL-Lite-CT, EQ-5D-5L).
    Summary · context
    Participants who achieved tirzepatide maximum tolerated dose (MTD; 10 or 15 mg; N = 670) during a 36-week (W) lead-in period were randomized (1:1) to continue receiving tirzepatide MTD or switch to placebo through W88.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In tirzepatide-treated adults, greater weight reduction and baseline physical function limitations were linked to numerically greater improvements in patient-reported outcomes (post hoc analysis).

    In plain wordsIn people taking tirzepatide, more weight loss and more physical limits at the start were linked to larger quality-of-life gains.

    Outcome
    IncreasePatient-reported outcomes by weight reduction and baseline physical function limitation
    Study

    n: not reported in source

    Outcome group
    Quality of life · Whole body
    Studied dose
    maximum tolerated dose (10 or 15 mg)As given in this study (human).

    Source sentences

    Summary
    Tirzepatide-treated participants with greater weight reduction and those with physical function limitations at baseline showed numerically greater improvements in PROs.
    2 context sentences
    Summary · context
    Post hoc analysis included changes in PROs by weight reduction categories and baseline Patient Global Impression of Status for physical activity response categories among tirzepatide-treated participants and by weight regain categories in the placebo group.
    Summary · context
    Participants who achieved tirzepatide maximum tolerated dose (MTD; 10 or 15 mg; N = 670) during a 36-week (W) lead-in period were randomized (1:1) to continue receiving tirzepatide MTD or switch to placebo through W88.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In adults who switched from tirzepatide to placebo, greater weight regain was associated with worsening of patient-reported outcomes (post hoc analysis).

    In plain wordsIn people who stopped tirzepatide and took placebo, more weight regain was linked to worse quality-of-life scores.

    Outcome
    DecreasePatient-reported outcomes with weight regain after switch to placebo
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Quality of life · Whole body
    Studied dose
    maximum tolerated dose (10 or 15 mg)As given in this study (human).

    Source sentences

    Summary
    Greater weight regain among participants who switched to placebo was associated with worsening of PROs.
    2 context sentences
    Summary · context
    Post hoc analysis included changes in PROs by weight reduction categories and baseline Patient Global Impression of Status for physical activity response categories among tirzepatide-treated participants and by weight regain categories in the placebo group.
    Summary · context
    Participants who achieved tirzepatide maximum tolerated dose (MTD; 10 or 15 mg; N = 670) during a 36-week (W) lead-in period were randomized (1:1) to continue receiving tirzepatide MTD or switch to placebo through W88.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT04660643

A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss

Eli Lilly and Companyn = 78329 Mar 2021 to 18 May 2023

Obesity · Overweight

Trial pageClinicalTrials.govUpdated 22 May 2024

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    12 Oct 2026, 12:58 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:07 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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