Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial.

Garvey WT, Frias JP, Jastreboff AM, le Roux CW, Sattar N, Aizenberg D, Mao H, Zhang S, Ahmad NN, Bunck MC, Benabbad I, Zhang XM

Lancet (London, England)26 Jun 2023Cited by 604 (Europe PMC)

PMID37385275DOI10.1016/s0140-6736(23)01200-xPepBankPUB-37385275

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Summary

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Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with obesity and type 2 diabetes, more participants on tirzepatide than on placebo reached a bodyweight reduction of 5% or more (79-83% versus 32%).
In plain wordsIn adults with obesity and type 2 diabetes, more people on tirzepatide than on placebo lost at least 5% of bodyweight.
Peptide
Tirzepatide
Outcome
IncreaseProportion with bodyweight reduction of 5% or more
Study
n = 938
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
10 mg and 15 mg · subcutaneous · 72 weeksAs given in this study (human).
Measurements
Proportion with 5% or more weight reduction
79 to 83%
tirzepatide
Proportion with 5% or more weight reduction
32%
placebo
Source sentences
Summary
More participants treated with tirzepatide versus placebo met bodyweight reduction thresholds of 5% or higher (79-83% vs 32%).
2 context sentences(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, randomised, placebo-controlled trial was conducted in seven countries.
Summary · context
Between March 29, 2021, and April 10, 2023, of 1514 adults assessed for eligibility, 938 (mean age 54·2 years [SD 10·6], 476 [51%] were female, 710 [76%] were White, and 561 [60%] were Hispanic or Latino) were randomly assigned and received at least one dose of tirzepatide 10 mg (n=312), tirzepatide…
Report a problemFND-3738527503
02HumanRandomized controlled trialEfficacy outcome
In adults with obesity and type 2 diabetes, tirzepatide 10 mg reduced bodyweight more than placebo at week 72 (treatment difference -9.6 percentage points).
In plain wordsIn adults with obesity and type 2 diabetes, tirzepatide 10 mg led to more weight loss than placebo after 72 weeks.
Peptide
Tirzepatide
Outcome
DecreasePercent change in bodyweight at week 72, 10 mg
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
10 mg · subcutaneous · 72 weeksAs given in this study (human).
Measurements
LS mean change in bodyweight
−12.8%
tirzepatide 10 mg
LS mean change in bodyweight
−3.2%
placebo
Estimated treatment difference
−9.6 percentage points
tirzepatide 10 mg vs placebo
Source sentences
Summary
Least-squares mean change in bodyweight at week 72 with tirzepatide 10 mg and 15 mg was -12·8% (SE 0·6) and -14·7% (0·5), respectively, and -3·2% (0·5) with placebo
3 context sentences(design, population, supporting numbers)
Summary · context
resulting in estimated treatment differences versus placebo of -9·6% percentage points (95% CI -11·1 to -8·1)
Summary · context
This phase 3, double-blind, randomised, placebo-controlled trial was conducted in seven countries.
Summary · context
Between March 29, 2021, and April 10, 2023, of 1514 adults assessed for eligibility, 938 (mean age 54·2 years [SD 10·6], 476 [51%] were female, 710 [76%] were White, and 561 [60%] were Hispanic or Latino) were randomly assigned and received at least one dose of tirzepatide 10 mg (n=312), tirzepatide…
Report a problemFND-3738527501
03HumanRandomized controlled trialEfficacy outcome
In adults with obesity and type 2 diabetes, tirzepatide 15 mg reduced bodyweight more than placebo at week 72 (treatment difference -11.6 percentage points).
In plain wordsIn adults with obesity and type 2 diabetes, tirzepatide 15 mg led to more weight loss than placebo after 72 weeks.
Peptide
Tirzepatide
Outcome
DecreasePercent change in bodyweight at week 72, 15 mg
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
15 mg · subcutaneous · 72 weeksAs given in this study (human).
Measurements
LS mean change in bodyweight
−14.7%
tirzepatide 15 mg
LS mean change in bodyweight
−3.2%
placebo
Estimated treatment difference
−11.6 percentage points
tirzepatide 15 mg vs placebo
Source sentences
Summary
Least-squares mean change in bodyweight at week 72 with tirzepatide 10 mg and 15 mg was -12·8% (SE 0·6) and -14·7% (0·5), respectively, and -3·2% (0·5) with placebo
3 context sentences(design, population, supporting numbers)
Summary · context
-11·6% percentage points (-13·0 to -10·1) with tirzepatide 15 mg (all p<0·0001).
Summary · context
This phase 3, double-blind, randomised, placebo-controlled trial was conducted in seven countries.
Summary · context
Between March 29, 2021, and April 10, 2023, of 1514 adults assessed for eligibility, 938 (mean age 54·2 years [SD 10·6], 476 [51%] were female, 710 [76%] were White, and 561 [60%] were Hispanic or Latino) were randomly assigned and received at least one dose of tirzepatide 10 mg (n=312), tirzepatide…
Report a problemFND-3738527502
04HumanRandomized controlled trialSafety outcome
In adults with obesity and type 2 diabetes, serious adverse events were reported by 68 participants (7%) overall in the trial.
In plain wordsIn adults with obesity and type 2 diabetes, 7% of all trial participants reported serious adverse events; the abstract gives no split by arm.
Peptide
Tirzepatide
Outcome
Direction not reportedSerious adverse events
Study
n = 938
Outcome group
Adverse events · Whole body
Studied dose
10 mg and 15 mg · subcutaneous · 72 weeksAs given in this study (human).
Measurements
Participants with serious adverse events
68 participants
overall
Participants with serious adverse events
7%
overall
Source sentences
Summary
Serious adverse events were reported by 68 (7%) participants overall
2 context sentences(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, randomised, placebo-controlled trial was conducted in seven countries.
Summary · context
Between March 29, 2021, and April 10, 2023, of 1514 adults assessed for eligibility, 938 (mean age 54·2 years [SD 10·6], 476 [51%] were female, 710 [76%] were White, and 561 [60%] were Hispanic or Latino) were randomly assigned and received at least one dose of tirzepatide 10 mg (n=312), tirzepatide…
Report a problemFND-3738527508
05HumanRandomized controlled trialSafety outcome
In adults with obesity and type 2 diabetes, two deaths occurred in the tirzepatide 10 mg group; the investigator did not consider them related to treatment.
In plain wordsIn adults with obesity and type 2 diabetes, two people in the tirzepatide 10 mg group died; the investigator judged the deaths unrelated to treatment.
Peptide
Tirzepatide
Outcome
Direction not reportedDeaths in the tirzepatide 10 mg group
Study
n = 312
Outcome group
Mortality · Whole body
Studied dose
10 mg · subcutaneous · 72 weeksAs given in this study (human).
Measurements
Deaths
2 participants
tirzepatide 10 mg
Source sentences
Summary
two deaths occurred in the tirzepatide 10 mg group, but deaths were not considered to be related to the study treatment by the investigator.
2 context sentences(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, randomised, placebo-controlled trial was conducted in seven countries.
Summary · context
Between March 29, 2021, and April 10, 2023, of 1514 adults assessed for eligibility, 938 (mean age 54·2 years [SD 10·6], 476 [51%] were female, 710 [76%] were White, and 561 [60%] were Hispanic or Latino) were randomly assigned and received at least one dose of tirzepatide 10 mg (n=312), tirzepatide…
Report a problemFND-3738527509
06HumanRandomized controlled trialSafety outcome
In adults with obesity and type 2 diabetes, nausea was among the most frequent adverse events with tirzepatide, mostly mild to moderate.
In plain wordsIn adults with obesity and type 2 diabetes, nausea was a common side effect of tirzepatide, mostly mild to moderate.
Peptide
Tirzepatide
Outcome
Direction not reportedNausea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
10 mg and 15 mg · subcutaneous · 72 weeksAs given in this study (human).
Source sentences
Summary
The most frequent adverse events with tirzepatide were gastrointestinal-related, including nausea, diarrhoea, and vomiting and were mostly mild to moderate in severity, with few events leading to treatment discontinuation (<5%).
2 context sentences(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, randomised, placebo-controlled trial was conducted in seven countries.
Summary · context
Between March 29, 2021, and April 10, 2023, of 1514 adults assessed for eligibility, 938 (mean age 54·2 years [SD 10·6], 476 [51%] were female, 710 [76%] were White, and 561 [60%] were Hispanic or Latino) were randomly assigned and received at least one dose of tirzepatide 10 mg (n=312), tirzepatide…
Report a problemFND-3738527504
07HumanRandomized controlled trialSafety outcome
In adults with obesity and type 2 diabetes, diarrhoea was among the most frequent adverse events with tirzepatide, mostly mild to moderate.
In plain wordsIn adults with obesity and type 2 diabetes, diarrhoea was a common side effect of tirzepatide, mostly mild to moderate.
Peptide
Tirzepatide
Outcome
Direction not reportedDiarrhoea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
10 mg and 15 mg · subcutaneous · 72 weeksAs given in this study (human).
Source sentences
Summary
The most frequent adverse events with tirzepatide were gastrointestinal-related, including nausea, diarrhoea, and vomiting and were mostly mild to moderate in severity, with few events leading to treatment discontinuation (<5%).
2 context sentences(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, randomised, placebo-controlled trial was conducted in seven countries.
Summary · context
Between March 29, 2021, and April 10, 2023, of 1514 adults assessed for eligibility, 938 (mean age 54·2 years [SD 10·6], 476 [51%] were female, 710 [76%] were White, and 561 [60%] were Hispanic or Latino) were randomly assigned and received at least one dose of tirzepatide 10 mg (n=312), tirzepatide…
Report a problemFND-3738527505
08HumanRandomized controlled trialSafety outcome
In adults with obesity and type 2 diabetes, vomiting was among the most frequent adverse events with tirzepatide, mostly mild to moderate.
In plain wordsIn adults with obesity and type 2 diabetes, vomiting was a common side effect of tirzepatide, mostly mild to moderate.
Peptide
Tirzepatide
Outcome
Direction not reportedVomiting
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
10 mg and 15 mg · subcutaneous · 72 weeksAs given in this study (human).
Source sentences
Summary
The most frequent adverse events with tirzepatide were gastrointestinal-related, including nausea, diarrhoea, and vomiting and were mostly mild to moderate in severity, with few events leading to treatment discontinuation (<5%).
2 context sentences(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, randomised, placebo-controlled trial was conducted in seven countries.
Summary · context
Between March 29, 2021, and April 10, 2023, of 1514 adults assessed for eligibility, 938 (mean age 54·2 years [SD 10·6], 476 [51%] were female, 710 [76%] were White, and 561 [60%] were Hispanic or Latino) were randomly assigned and received at least one dose of tirzepatide 10 mg (n=312), tirzepatide…
Report a problemFND-3738527506
09HumanRandomized controlled trialSafety outcome
In adults with obesity and type 2 diabetes, few adverse events with tirzepatide led to treatment discontinuation (<5%).
In plain wordsIn adults with obesity and type 2 diabetes, few side effects of tirzepatide led people to stop treatment (under 5%).
Peptide
Tirzepatide
Outcome
Direction not reportedTreatment discontinuation due to adverse events
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
10 mg and 15 mg · subcutaneous · 72 weeksAs given in this study (human).
Measurements
Events leading to discontinuation
< 5%
tirzepatide
Source sentences
Summary
with few events leading to treatment discontinuation (<5%).
2 context sentences(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, randomised, placebo-controlled trial was conducted in seven countries.
Summary · context
Between March 29, 2021, and April 10, 2023, of 1514 adults assessed for eligibility, 938 (mean age 54·2 years [SD 10·6], 476 [51%] were female, 710 [76%] were White, and 561 [60%] were Hispanic or Latino) were randomly assigned and received at least one dose of tirzepatide 10 mg (n=312), tirzepatide…
Report a problemFND-3738527507

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

Registered trials3

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

3 trials · 2 not yet recruiting · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

Not yet recruitingPhase 2NCT07731256

Semaglutide for Low Back Pain

Washington University School of Medicinen = 250est. 1 Feb 2027 to est. 1 Sept 2031

Lower Back Pain · Obesity (BMI>30) · Chronic Lower Back Pain · glp1 Agonist

Trial page ClinicalTrials.govUpdated 28 Jul 2026

Not yet recruitingPhase 4NCT07756359

Tirzepatide for Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)

University of North Carolina, Chapel Hilln = 20est. Sept 2026 to est. Sept 2027

Pouch, Ileal · Pouches, Ileoanal · Bowel Diseases, Inflammatory

Trial page ClinicalTrials.govUpdated 10 Aug 2026

CompletedPhase 3Results postedNCT04657003

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight

Eli Lilly and Companyn = 93829 Mar 2021 to 10 Apr 2023

Type 2 Diabetes · Overweight · Obesity

Trial page ClinicalTrials.govUpdated 8 Apr 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.

Version 2Current
9 Oct 2026, 19:08 UTC
Study results updated
Version 1
9 Oct 2026, 03:07 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

MeSH terms

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