Efficacy and safety of retatrutide, a GIP, GLP-1, and glucagon receptor agonist, in people with type 2 diabetes and inadequate glycaemic control with diet and exercise (TRANSCEND-T2D-1): a double-blind, randomised, phase 3 trial.

Bajaj HS, Welch M, Shah P, Luna E, Jaouimaa FZ, Liu B, Liu R, Chen Y, Patel H, Bartee A

Lancet (London, England)6 Jun 2026Cited by 12 (Europe PMC)

PMID42250575DOI10.1016/s0140-6736(26)00967-0PepBankPUB-42250575

Publisher page PubMedAsk about this study

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: Publisher copyright. Results still quote short attributed sentences.

Results from this study10

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

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, retatrutide 4 mg lowered HbA1c more than placebo at week 40.
In plain wordsIn adults with type 2 diabetes, retatrutide 4 mg lowered HbA1c more than placebo.
Peptide
Retatrutide
Outcome
DecreaseHbA1c change from baseline to week 40
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
4 mg once weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
HbA1c change
−1.69%
retatrutide 4 mg
HbA1c difference vs placebo
−0.88%
retatrutide 4 mg
Source sentences
Summary
the mean change from baseline in HbA_1c concentration was -1·69% (SE 0·11) with retatrutide 4 mg
Summary
resulting in estimated treatment differences versus placebo of -0·88% (95% CI -1·18 to -0·59) with retatrutide 4 mg
2 context sentences(design, population, supporting numbers)
Summary · context
In this 40-week, phase 3, randomised, double-blind, placebo-controlled trial at 48 sites in the USA, Mexico, and India, we recruited adults (aged ≥18 years) with type 2 diabetes that is inadequately controlled by diet and exercise alone, glycated haemoglobin (HbA_1c) between 7·0% and 9·5%…
Summary · context
Participants were randomly assigned (1:1:1:1) to receive retatrutide (4 mg, 9 mg, or 12 mg) or placebo by once-weekly subcutaneous injection.
Report a problemFND-4225057501
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, retatrutide 9 mg lowered HbA1c more than placebo at week 40.
In plain wordsIn adults with type 2 diabetes, retatrutide 9 mg lowered HbA1c more than placebo.
Peptide
Retatrutide
Outcome
DecreaseHbA1c change from baseline to week 40
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
9 mg once weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
HbA1c change
−1.86%
retatrutide 9 mg
HbA1c difference vs placebo
−1.04%
retatrutide 9 mg
Source sentences
Summary
-1·86% (0·10) with 9 mg
3 context sentences(design, population, supporting numbers)
Summary · context
-1·04% (-1·32 to -0·76) with 9 mg
Summary · context
In this 40-week, phase 3, randomised, double-blind, placebo-controlled trial at 48 sites in the USA, Mexico, and India, we recruited adults (aged ≥18 years) with type 2 diabetes that is inadequately controlled by diet and exercise alone, glycated haemoglobin (HbA_1c) between 7·0% and 9·5%…
Summary · context
Participants were randomly assigned (1:1:1:1) to receive retatrutide (4 mg, 9 mg, or 12 mg) or placebo by once-weekly subcutaneous injection.
Report a problemFND-4225057502
03HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, retatrutide 12 mg lowered HbA1c more than placebo at week 40.
In plain wordsIn adults with type 2 diabetes, retatrutide 12 mg lowered HbA1c more than placebo.
Peptide
Retatrutide
Outcome
DecreaseHbA1c change from baseline to week 40
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
12 mg once weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
HbA1c change
−1.94%
retatrutide 12 mg
HbA1c difference vs placebo
−1.12%
retatrutide 12 mg
Source sentences
Summary
-1·94% (0·08) with 12 mg
3 context sentences(design, population, supporting numbers)
Summary · context
-1·12% (-1·39 to -0·85) with 12 mg (all p<0·0001)
Summary · context
In this 40-week, phase 3, randomised, double-blind, placebo-controlled trial at 48 sites in the USA, Mexico, and India, we recruited adults (aged ≥18 years) with type 2 diabetes that is inadequately controlled by diet and exercise alone, glycated haemoglobin (HbA_1c) between 7·0% and 9·5%…
Summary · context
Participants were randomly assigned (1:1:1:1) to receive retatrutide (4 mg, 9 mg, or 12 mg) or placebo by once-weekly subcutaneous injection.
Report a problemFND-4225057503
04HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, retatrutide 4 mg reduced bodyweight more than placebo at week 40.
In plain wordsIn adults with type 2 diabetes, retatrutide 4 mg reduced body weight more than placebo.
Peptide
Retatrutide
Outcome
DecreasePercentage change in bodyweight from baseline to week 40
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
4 mg once weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
Bodyweight change
−11.5%
retatrutide 4 mg
Bodyweight change
−2.6%
placebo
Source sentences
Summary
The mean percentage change from baseline in bodyweight was -11·5% (SE 0·7) with retatrutide 4 mg
3 context sentences(design, population, supporting numbers)
Summary · context
versus -2·6% (0·5) with placebo.
Summary · context
In this 40-week, phase 3, randomised, double-blind, placebo-controlled trial at 48 sites in the USA, Mexico, and India, we recruited adults (aged ≥18 years) with type 2 diabetes that is inadequately controlled by diet and exercise alone, glycated haemoglobin (HbA_1c) between 7·0% and 9·5%…
Summary · context
Participants were randomly assigned (1:1:1:1) to receive retatrutide (4 mg, 9 mg, or 12 mg) or placebo by once-weekly subcutaneous injection.
Report a problemFND-4225057504
05HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, retatrutide 9 mg reduced bodyweight more than placebo at week 40.
In plain wordsIn adults with type 2 diabetes, retatrutide 9 mg reduced body weight more than placebo.
Peptide
Retatrutide
Outcome
DecreasePercentage change in bodyweight from baseline to week 40
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
9 mg once weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
Bodyweight change
−13.9%
retatrutide 9 mg
Bodyweight change
−2.6%
placebo
Source sentences
Summary
-13·9% (0·8) with 9 mg
3 context sentences(design, population, supporting numbers)
Summary · context
versus -2·6% (0·5) with placebo.
Summary · context
In this 40-week, phase 3, randomised, double-blind, placebo-controlled trial at 48 sites in the USA, Mexico, and India, we recruited adults (aged ≥18 years) with type 2 diabetes that is inadequately controlled by diet and exercise alone, glycated haemoglobin (HbA_1c) between 7·0% and 9·5%…
Summary · context
Participants were randomly assigned (1:1:1:1) to receive retatrutide (4 mg, 9 mg, or 12 mg) or placebo by once-weekly subcutaneous injection.
Report a problemFND-4225057505
06HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, retatrutide 12 mg reduced bodyweight more than placebo at week 40.
In plain wordsIn adults with type 2 diabetes, retatrutide 12 mg reduced body weight more than placebo.
Peptide
Retatrutide
Outcome
DecreasePercentage change in bodyweight from baseline to week 40
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
12 mg once weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
Bodyweight change
−15.3%
retatrutide 12 mg
Bodyweight change
−2.6%
placebo
Source sentences
Summary
-15·3% (0·8) with 12 mg
3 context sentences(design, population, supporting numbers)
Summary · context
versus -2·6% (0·5) with placebo.
Summary · context
In this 40-week, phase 3, randomised, double-blind, placebo-controlled trial at 48 sites in the USA, Mexico, and India, we recruited adults (aged ≥18 years) with type 2 diabetes that is inadequately controlled by diet and exercise alone, glycated haemoglobin (HbA_1c) between 7·0% and 9·5%…
Summary · context
Participants were randomly assigned (1:1:1:1) to receive retatrutide (4 mg, 9 mg, or 12 mg) or placebo by once-weekly subcutaneous injection.
Report a problemFND-4225057506
07HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, the most frequent adverse events with retatrutide were generally mild to moderate gastrointestinal events that subsided over time.
In plain wordsIn adults with type 2 diabetes, retatrutide most often caused mild to moderate stomach and gut side effects that eased over time.
Peptide
Retatrutide
Outcome
Not applicableGastrointestinal adverse events
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
4 to 12 mg once weekly · subcutaneous · 40 weeksAs given in this study (human).
Source sentences
Summary
The most frequent adverse events with retatrutide were generally mild to moderate gastrointestinal events, which subsided over time.
2 context sentences(design, population, supporting numbers)
Summary · context
In this 40-week, phase 3, randomised, double-blind, placebo-controlled trial at 48 sites in the USA, Mexico, and India, we recruited adults (aged ≥18 years) with type 2 diabetes that is inadequately controlled by diet and exercise alone, glycated haemoglobin (HbA_1c) between 7·0% and 9·5%…
Summary · context
Participants were randomly assigned (1:1:1:1) to receive retatrutide (4 mg, 9 mg, or 12 mg) or placebo by once-weekly subcutaneous injection.
Report a problemFND-4225057507
08HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, discontinuations due to adverse events were higher with retatrutide than with placebo.
In plain wordsIn adults with type 2 diabetes, more people stopped retatrutide because of side effects than stopped placebo.
Peptide
Retatrutide
Outcome
IncreaseDiscontinuation due to adverse events
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
4 to 12 mg once weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
Discontinuation due to AEs
2 to 5%
retatrutide
Discontinuation due to AEs
0%
placebo
Source sentences
Summary
Study intervention discontinuations due to adverse events were 2-5% with retatrutide and 0% with placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
In this 40-week, phase 3, randomised, double-blind, placebo-controlled trial at 48 sites in the USA, Mexico, and India, we recruited adults (aged ≥18 years) with type 2 diabetes that is inadequately controlled by diet and exercise alone, glycated haemoglobin (HbA_1c) between 7·0% and 9·5%…
Summary · context
Participants were randomly assigned (1:1:1:1) to receive retatrutide (4 mg, 9 mg, or 12 mg) or placebo by once-weekly subcutaneous injection.
Report a problemFND-4225057508
09HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, no severe hypoglycaemia was reported in the trial.
In plain wordsIn adults with type 2 diabetes, no severe low blood sugar was reported in the trial.
Peptide
Retatrutide
Outcome
No significant changeSevere hypoglycaemia
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Studied dose
4 to 12 mg once weekly · subcutaneous · 40 weeksAs given in this study (human).
Source sentences
Summary
No severe hypoglycaemia was reported.
2 context sentences(design, population, supporting numbers)
Summary · context
In this 40-week, phase 3, randomised, double-blind, placebo-controlled trial at 48 sites in the USA, Mexico, and India, we recruited adults (aged ≥18 years) with type 2 diabetes that is inadequately controlled by diet and exercise alone, glycated haemoglobin (HbA_1c) between 7·0% and 9·5%…
Summary · context
Participants were randomly assigned (1:1:1:1) to receive retatrutide (4 mg, 9 mg, or 12 mg) or placebo by once-weekly subcutaneous injection.
Report a problemFND-4225057509
10HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, two deaths occurred in the retatrutide 4 mg group and were unrelated to the study drug.
In plain wordsIn adults with type 2 diabetes, two people died in the retatrutide 4 mg group; the deaths were unrelated to the study drug.
Peptide
Retatrutide
Outcome
Not applicableDeaths
Study
n: not reported in source
Outcome group
Mortality · Whole body
Studied dose
4 mg once weekly · subcutaneous · 40 weeksAs given in this study (human).
Source sentences
Summary
Two deaths occurred during the study, both in the retatrutide 4 mg group and unrelated to the study drug.
2 context sentences(design, population, supporting numbers)
Summary · context
In this 40-week, phase 3, randomised, double-blind, placebo-controlled trial at 48 sites in the USA, Mexico, and India, we recruited adults (aged ≥18 years) with type 2 diabetes that is inadequately controlled by diet and exercise alone, glycated haemoglobin (HbA_1c) between 7·0% and 9·5%…
Summary · context
Participants were randomly assigned (1:1:1:1) to receive retatrutide (4 mg, 9 mg, or 12 mg) or placebo by once-weekly subcutaneous injection.
Report a problemFND-4225057510

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 · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT06354660

Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)

Eli Lilly and Companyn = 53710 Apr 2024 to 20 Feb 2026

Diabetes Type 2

Trial page ClinicalTrials.govUpdated 5 Mar 2026

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, 18:17 UTC
Study results updated
Version 1
9 Oct 2026, 03:04 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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