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Study · Randomized controlled trial · 2025

6 results

Gastrointestinal tolerability and weight reduction associated with tirzepatide in adults with obesity or overweight with and without type 2 diabetes in the SURMOUNT-1 to -4 trials.

Rubino DM, Pedersen SD, Connery L, Cao D, Chigutsa F, Stefanski A, Fraseur Brumm J, Griffin R, Gerber C

Diabetes, obesity & metabolism9 Jan 2025Cited by 15 (Europe PMC)

PMID39789843 (opens in a new tab)PMCIDPMC11885085 (opens in a new tab)DOI10.1111/dom.16176 (opens in a new tab)PepBankPUB-39789843
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In adults with obesity or overweight, more participants reported gastrointestinal adverse events with tirzepatide than with placebo.

    In plain wordsIn adults with obesity or overweight, more people on tirzepatide than on placebo reported stomach and bowel side effects.

    Peptide
    Tirzepatide
    Outcome
    IncreaseParticipants reporting gastrointestinal adverse events
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Measurements

    Participants with GI AEs
    27.8 to 72.8%
    tirzepatide arms
    Participants with GI AEs
    12.2 to 32.5%
    placebo

    Source sentences

    Summary
    More participants reported GI AEs in the tirzepatide treatment arms (27.8%-72.8%) than with placebo (12.2%-32.5%).
    2 context sentences
    Summary · context
    SURMOUNT-1 to -4 were global Phase 3 clinical trials evaluating the safety and efficacy of tirzepatide among participants with obesity or overweight with or without type 2 diabetes (T2D).
    Summary · context
    Participants were randomly assigned to receive once weekly subcutaneous tirzepatide or placebo.
  2. 02HumanRandomized controlled trialSafety outcome

    In adults with obesity or overweight, most gastrointestinal adverse events with tirzepatide were non-serious and occurred during dose escalation.

    In plain wordsIn adults with obesity or overweight, most stomach and bowel side effects on tirzepatide were not serious and happened while the dose was rising.

    Peptide
    Tirzepatide
    Outcome
    Not applicableSeriousness and timing of gastrointestinal adverse events
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Most GI AEs were non-serious and occurred during dose escalation.
    2 context sentences
    Summary · context
    SURMOUNT-1 to -4 were global Phase 3 clinical trials evaluating the safety and efficacy of tirzepatide among participants with obesity or overweight with or without type 2 diabetes (T2D).
    Summary · context
    Participants were randomly assigned to receive once weekly subcutaneous tirzepatide or placebo.
  3. 03HumanRandomized controlled trialSafety outcome

    In adults with obesity or overweight, between 1.0% and 10.5% of tirzepatide-treated participants stopped treatment because of gastrointestinal adverse events.

    In plain wordsIn adults with obesity or overweight, 1.0% to 10.5% of people on tirzepatide stopped treatment because of stomach and bowel side effects.

    Peptide
    Tirzepatide
    Outcome
    Not applicableDiscontinuation due to gastrointestinal adverse events
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Measurements

    Discontinuation due to GI AEs
    1 to 10.5%
    tirzepatide-treated participants

    Source sentences

    Summary
    Between 1.0% and 10.5% of tirzepatide-treated participants discontinued treatment due to GI AEs.
    2 context sentences
    Summary · context
    SURMOUNT-1 to -4 were global Phase 3 clinical trials evaluating the safety and efficacy of tirzepatide among participants with obesity or overweight with or without type 2 diabetes (T2D).
    Summary · context
    Participants were randomly assigned to receive once weekly subcutaneous tirzepatide or placebo.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In adults with obesity or overweight, weight reduction with tirzepatide was similar among participants reporting no nausea, nausea alone, or any nausea, vomiting or diarrhoea.

    In plain wordsIn adults with obesity or overweight, weight loss on tirzepatide was similar whether or not people had nausea, vomiting or diarrhoea.

    Peptide
    Tirzepatide
    Outcome
    No significant changeWeight reduction by presence of nausea, vomiting or diarrhoea
    Study

    n: not reported in source

    Comparator
    Participants reporting no nausea, nausea alone or any N/V/D
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Weight reduction with tirzepatide was similar among participants reporting no nausea, nausea alone, or any N/V/D.
    2 context sentences
    Summary · context
    SURMOUNT-1 to -4 were global Phase 3 clinical trials evaluating the safety and efficacy of tirzepatide among participants with obesity or overweight with or without type 2 diabetes (T2D).
    Summary · context
    Participants were randomly assigned to receive once weekly subcutaneous tirzepatide or placebo.
  5. 05HumanRandomized controlled trialMechanism

    In adults with obesity or overweight, mediation analyses suggested that nausea, vomiting, diarrhoea and dyspepsia were associated with up to 3.1% of total weight reduction on tirzepatide.

    In plain wordsIn adults with obesity or overweight, stomach side effects were linked to only a small part, up to 3.1%, of the weight loss on tirzepatide.

    Peptide
    Tirzepatide
    Outcome
    Not applicableContribution of nausea, vomiting, diarrhoea and dyspepsia to weight reduction (mediation)
    Study

    n: not reported in source

    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Measurements

    Weight reduction associated with N/V/D and dyspepsia
    ≤ 3.1%
    mediation analysis

    Source sentences

    Summary
    Mediation analyses suggested that N/V/D and dyspepsia were associated with up to 3.1% of total weight reduction.
    2 context sentences
    Summary · context
    SURMOUNT-1 to -4 were global Phase 3 clinical trials evaluating the safety and efficacy of tirzepatide among participants with obesity or overweight with or without type 2 diabetes (T2D).
    Summary · context
    Participants were randomly assigned to receive once weekly subcutaneous tirzepatide or placebo.
  6. 06HumanRandomized controlled trialSafety outcome

    In adults with obesity or overweight, first use of antidiarrheal and antiemetic medication was most commonly reported during dose escalation of tirzepatide.

    In plain wordsIn adults with obesity or overweight, medicines for diarrhoea or vomiting were most often first used while the tirzepatide dose was rising.

    Peptide
    Tirzepatide
    Outcome
    Not applicableTiming of first antidiarrheal and antiemetic medication use
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    When required, first use of antidiarrheal and antiemetic medication was most commonly reported during dose escalation.
    2 context sentences
    Summary · context
    SURMOUNT-1 to -4 were global Phase 3 clinical trials evaluating the safety and efficacy of tirzepatide among participants with obesity or overweight with or without type 2 diabetes (T2D).
    Summary · context
    Participants were randomly assigned to receive once weekly subcutaneous tirzepatide or placebo.

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

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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