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Study · Randomized controlled trial · 2024

10 results

Gastrointestinal adverse events and weight reduction in people with type 2 diabetes treated with tirzepatide in the SURPASS clinical trials.

Patel H, Khunti K, Rodbard HW, Bajaj HS, Bray R, Kindracki Z, Rodríguez Á

Diabetes, obesity & metabolism18 Oct 2023Cited by 34 (Europe PMC)

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 study10

10 results from studies that gave the peptide. 10 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In adults with type 2 diabetes, nausea occurred in 12% to 24% of participants given tirzepatide across the SURPASS-1 to -5 trials.

    In plain wordsIn adults with type 2 diabetes, nausea affected 12% to 24% of people on tirzepatide.

    Outcome
    Not applicableNausea incidence
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    5, 10 or 15 mg once weeklyAs given in this study (human).

    Measurements

    Nausea incidence
    12 to 24%
    tirzepatide

    Source sentences

    Summary
    Across the SURPASS-1 to -5 trials (N = 6263), nausea (12%-24%), diarrhoea (12%-22%), and vomiting (2%-13%) were the most common GI AEs reported with tirzepatide; these were transient and of mild-to-moderate severity.
    1 context sentence
    Summary · context
    Participants with type 2 diabetes were randomized to receive once-weekly tirzepatide (5, 10 or 15 mg) or comparator (placebo, semaglutide 1 mg once weekly, or titrated daily basal insulins) as monotherapy or added on to background antihyperglycaemic medication(s).
  2. 02HumanRandomized controlled trialSafety outcome

    In adults with type 2 diabetes, diarrhoea occurred in 12% to 22% of participants given tirzepatide across the SURPASS-1 to -5 trials.

    In plain wordsIn adults with type 2 diabetes, diarrhoea affected 12% to 22% of people on tirzepatide.

    Outcome
    Not applicableDiarrhoea incidence
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    5, 10 or 15 mg once weeklyAs given in this study (human).

    Measurements

    Diarrhoea incidence
    12 to 22%
    tirzepatide

    Source sentences

    Summary
    Across the SURPASS-1 to -5 trials (N = 6263), nausea (12%-24%), diarrhoea (12%-22%), and vomiting (2%-13%) were the most common GI AEs reported with tirzepatide; these were transient and of mild-to-moderate severity.
    1 context sentence
    Summary · context
    Participants with type 2 diabetes were randomized to receive once-weekly tirzepatide (5, 10 or 15 mg) or comparator (placebo, semaglutide 1 mg once weekly, or titrated daily basal insulins) as monotherapy or added on to background antihyperglycaemic medication(s).
  3. 03HumanRandomized controlled trialSafety outcome

    In adults with type 2 diabetes, vomiting occurred in 2% to 13% of participants given tirzepatide across the SURPASS-1 to -5 trials.

    In plain wordsIn adults with type 2 diabetes, vomiting affected 2% to 13% of people on tirzepatide.

    Outcome
    Not applicableVomiting incidence
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    5, 10 or 15 mg once weeklyAs given in this study (human).

    Measurements

    Vomiting incidence
    2 to 13%
    tirzepatide

    Source sentences

    Summary
    Across the SURPASS-1 to -5 trials (N = 6263), nausea (12%-24%), diarrhoea (12%-22%), and vomiting (2%-13%) were the most common GI AEs reported with tirzepatide; these were transient and of mild-to-moderate severity.
    1 context sentence
    Summary · context
    Participants with type 2 diabetes were randomized to receive once-weekly tirzepatide (5, 10 or 15 mg) or comparator (placebo, semaglutide 1 mg once weekly, or titrated daily basal insulins) as monotherapy or added on to background antihyperglycaemic medication(s).
  4. 04HumanRandomized controlled trialSafety outcome

    In adults with type 2 diabetes, the gastrointestinal adverse events with tirzepatide were transient and of mild-to-moderate severity.

    In plain wordsIn adults with type 2 diabetes, stomach and bowel side effects of tirzepatide were short-lived and mild to moderate.

    Outcome
    Not applicableSeverity and duration of gastrointestinal adverse events
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    5, 10 or 15 mg once weeklyAs given in this study (human).

    Source sentences

    Summary
    these were transient and of mild-to-moderate severity.
    2 context sentences
    Summary · context
    Across the SURPASS-1 to -5 trials (N = 6263), nausea (12%-24%), diarrhoea (12%-22%), and vomiting (2%-13%) were the most common GI AEs reported with tirzepatide; these were transient and of mild-to-moderate severity.
    Summary · context
    Participants with type 2 diabetes were randomized to receive once-weekly tirzepatide (5, 10 or 15 mg) or comparator (placebo, semaglutide 1 mg once weekly, or titrated daily basal insulins) as monotherapy or added on to background antihyperglycaemic medication(s).
  5. 05HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes who reported nausea, vomiting or diarrhoea, tirzepatide reduced mean body weight by 6.2 to 14.9 kg at the primary timepoint.

    In plain wordsIn adults with type 2 diabetes who had nausea, vomiting or diarrhoea, tirzepatide still lowered body weight by 6.2 to 14.9 kg.

    Outcome
    DecreaseWeight change in participants with nausea, vomiting or diarrhoea
    Study

    n: not reported in source

    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    5, 10 or 15 mg once weeklyAs given in this study (human).

    Measurements

    Weight reduction
    6.2 to 14.9 kg
    reported N/V/D

    Source sentences

    Summary
    Mean weight reduction at the primary timepoint with tirzepatide was consistent between participants who reported N/V/D (-6.2 to -14.9 kg) and those who did not report N/V/D (-6.2 to -13.3 kg).
    1 context sentence
    Summary · context
    Participants with type 2 diabetes were randomized to receive once-weekly tirzepatide (5, 10 or 15 mg) or comparator (placebo, semaglutide 1 mg once weekly, or titrated daily basal insulins) as monotherapy or added on to background antihyperglycaemic medication(s).
  6. 06HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes who did not report nausea, vomiting or diarrhoea, tirzepatide reduced mean body weight by 6.2 to 13.3 kg at the primary timepoint.

    In plain wordsIn adults with type 2 diabetes who had no nausea, vomiting or diarrhoea, tirzepatide lowered body weight by 6.2 to 13.3 kg.

    Outcome
    DecreaseWeight change in participants without nausea, vomiting or diarrhoea
    Study

    n: not reported in source

    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    5, 10 or 15 mg once weeklyAs given in this study (human).

    Measurements

    Weight reduction
    6.2 to 13.3 kg
    no N/V/D

    Source sentences

    Summary
    Mean weight reduction at the primary timepoint with tirzepatide was consistent between participants who reported N/V/D (-6.2 to -14.9 kg) and those who did not report N/V/D (-6.2 to -13.3 kg).
    1 context sentence
    Summary · context
    Participants with type 2 diabetes were randomized to receive once-weekly tirzepatide (5, 10 or 15 mg) or comparator (placebo, semaglutide 1 mg once weekly, or titrated daily basal insulins) as monotherapy or added on to background antihyperglycaemic medication(s).
  7. 07HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes, tirzepatide reduced weight significantly more than placebo within the nausea, vomiting or diarrhoea and GI adverse event subgroups.

    In plain wordsIn adults with type 2 diabetes who had stomach or bowel side effects, tirzepatide lowered weight more than placebo.

    Outcome
    DecreaseWeight reduction versus placebo in participants with gastrointestinal adverse events
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    5, 10 or 15 mg once weeklyAs given in this study (human).

    Source sentences

    Summary
    Mean weight reduction was significantly (P < 0.01) greater with tirzepatide compared with placebo, semaglutide 1 mg, and basal insulins within the N/V/D and GI AEs subgroups.
    1 context sentence
    Summary · context
    Participants with type 2 diabetes were randomized to receive once-weekly tirzepatide (5, 10 or 15 mg) or comparator (placebo, semaglutide 1 mg once weekly, or titrated daily basal insulins) as monotherapy or added on to background antihyperglycaemic medication(s).
  8. 08HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes, tirzepatide reduced weight significantly more than semaglutide 1 mg within the nausea, vomiting or diarrhoea and GI adverse event subgroups.

    In plain wordsIn adults with type 2 diabetes who had stomach or bowel side effects, tirzepatide lowered weight more than semaglutide 1 mg.

    Outcome
    DecreaseWeight reduction versus semaglutide 1 mg in participants with gastrointestinal adverse events
    Study

    n: not reported in source

    Comparator
    Semaglutide 1 mg
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    5, 10 or 15 mg once weeklyAs given in this study (human).

    Source sentences

    Summary
    Mean weight reduction was significantly (P < 0.01) greater with tirzepatide compared with placebo, semaglutide 1 mg, and basal insulins within the N/V/D and GI AEs subgroups.
    1 context sentence
    Summary · context
    Participants with type 2 diabetes were randomized to receive once-weekly tirzepatide (5, 10 or 15 mg) or comparator (placebo, semaglutide 1 mg once weekly, or titrated daily basal insulins) as monotherapy or added on to background antihyperglycaemic medication(s).
  9. 09HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes, tirzepatide reduced weight significantly more than basal insulins within the nausea, vomiting or diarrhoea and GI adverse event subgroups.

    In plain wordsIn adults with type 2 diabetes who had stomach or bowel side effects, tirzepatide lowered weight more than basal insulins.

    Outcome
    DecreaseWeight reduction versus basal insulins in participants with gastrointestinal adverse events
    Study

    n: not reported in source

    Comparator
    Titrated daily basal insulins
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    5, 10 or 15 mg once weeklyAs given in this study (human).

    Source sentences

    Summary
    Mean weight reduction was significantly (P < 0.01) greater with tirzepatide compared with placebo, semaglutide 1 mg, and basal insulins within the N/V/D and GI AEs subgroups.
    1 context sentence
    Summary · context
    Participants with type 2 diabetes were randomized to receive once-weekly tirzepatide (5, 10 or 15 mg) or comparator (placebo, semaglutide 1 mg once weekly, or titrated daily basal insulins) as monotherapy or added on to background antihyperglycaemic medication(s).
  10. 10HumanRandomized controlled trialMechanism

    In adults with type 2 diabetes, nausea, vomiting, diarrhoea and GI adverse events mediated less than 6% of the weight difference between tirzepatide and comparators.

    In plain wordsIn adults with type 2 diabetes, stomach side effects explained under 6% of the extra weight loss with tirzepatide versus other treatments.

    Outcome
    No significant changeMediation of weight change by gastrointestinal adverse events
    Study

    n: not reported in source

    Comparator
    Comparators pooled
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    5, 10 or 15 mg once weeklyAs given in this study (human).

    Measurements

    Mediated proportion
    < 6%
    N/V/D and GI AEs

    Source sentences

    Summary
    Mediation analyses suggested minimal contribution (<6%) of N/V/D and GI AEs to the overall difference in weight change between tirzepatide and comparators.
    1 context sentence
    Summary · context
    Participants with type 2 diabetes were randomized to receive once-weekly tirzepatide (5, 10 or 15 mg) or comparator (placebo, semaglutide 1 mg once weekly, or titrated daily basal insulins) as monotherapy or added on to background antihyperglycaemic medication(s).

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 3Current

    11 Oct 2026, 00:04 UTC

    Study results updated

  2. Version 2

    9 Oct 2026, 03:07 UTC

    Study data updated · source update from Europe PMC

  3. Version 1

    9 Oct 2026, 03:06 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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