Efficacy and safety of mazdutide in adults with obesity or overweight: a US-based, multicentre, phase 2, randomised, placebo-controlled clinical trial.

Hsia SH, Bays HE, Billings LK, Weideman AMK, Mather KJ, Coskun T, Haupt A, Thomas MK, Tham LS, Calderon B, Ni W, De Araujo OFG

The lancet. Diabetes & endocrinology21 Aug 2026

PMID42628555DOI10.1016/s2213-8587(26)00160-9PepBankPUB-42628555

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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: Publisher copyright. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In US adults with obesity or overweight without type 2 diabetes, estimated treatment differences versus placebo in body weight ranged from -6.5% to -17.2% across mazdutide doses (p<0.0001 for all).
In plain wordsIn US adults with obesity or overweight and no type 2 diabetes, every mazdutide dose lowered body weight significantly more than placebo.
Peptide
Mazdutide
Outcome
DecreaseEstimated treatment difference versus placebo in body weight at week 32
Study
n = 179
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
3-6 mg, 10 mg and 16 mg · subcutaneous · 32 weeksAs given in this study (human).
Source sentences
Summary
Estimated treatment differences versus placebo ranged from -6·5% to -17·2% (p<0·0001, all comparisons).
2 context sentences(design, population, supporting numbers)
Summary · context
We aimed to evaluate the efficacy, safety, and tolerability of once-weekly mazdutide across a dose range up to 16 mg in adults with obesity or overweight without type 2 diabetes in the USA.
Summary · context
Between Nov 17, 2023, and July 9, 2025, 179 participants were randomly allocated to receive mazdutide (32 participants to 3-6 mg, 48 to 10 mg, and 51 to 16 mg) or placebo (48 participants).
Report a problemFND-4262855504
02HumanRandomized controlled trialEfficacy outcome
In US adults with obesity or overweight without type 2 diabetes, mazdutide 3-6 mg reduced body weight more than placebo at week 32 (-7.3% versus -0.9%).
In plain wordsIn US adults with obesity or overweight and no type 2 diabetes, mazdutide 3-6 mg lowered body weight more than placebo after 32 weeks.
Peptide
Mazdutide
Outcome
DecreasePercent body weight change at week 32 (3-6 mg)
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
3-6 mg · subcutaneous · 32 weeksAs given in this study (human).
Measurements
Body weight change
−7.3%
mazdutide 3-6 mg
Body weight change
−0.9%
placebo
Source sentences
Summary
At 32 weeks, the least-squares mean percentage change from baseline in bodyweight was -7·3% (SE 0·9) with mazdutide 3-6 mg, -15·6% (0·7) with 10 mg, and -18·1% (1·0) with 16 mg, versus -0·9% (0·8) with placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
We aimed to evaluate the efficacy, safety, and tolerability of once-weekly mazdutide across a dose range up to 16 mg in adults with obesity or overweight without type 2 diabetes in the USA.
Summary · context
Between Nov 17, 2023, and July 9, 2025, 179 participants were randomly allocated to receive mazdutide (32 participants to 3-6 mg, 48 to 10 mg, and 51 to 16 mg) or placebo (48 participants).
Report a problemFND-4262855501
03HumanRandomized controlled trialEfficacy outcome
In US adults with obesity or overweight without type 2 diabetes, mazdutide 10 mg reduced body weight more than placebo at week 32 (-15.6% versus -0.9%).
In plain wordsIn US adults with obesity or overweight and no type 2 diabetes, mazdutide 10 mg lowered body weight more than placebo after 32 weeks.
Peptide
Mazdutide
Outcome
DecreasePercent body weight change at week 32 (10 mg)
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
10 mg · subcutaneous · 32 weeksAs given in this study (human).
Measurements
Body weight change
−15.6%
mazdutide 10 mg
Body weight change
−0.9%
placebo
Source sentences
Summary
At 32 weeks, the least-squares mean percentage change from baseline in bodyweight was -7·3% (SE 0·9) with mazdutide 3-6 mg, -15·6% (0·7) with 10 mg, and -18·1% (1·0) with 16 mg, versus -0·9% (0·8) with placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
We aimed to evaluate the efficacy, safety, and tolerability of once-weekly mazdutide across a dose range up to 16 mg in adults with obesity or overweight without type 2 diabetes in the USA.
Summary · context
Between Nov 17, 2023, and July 9, 2025, 179 participants were randomly allocated to receive mazdutide (32 participants to 3-6 mg, 48 to 10 mg, and 51 to 16 mg) or placebo (48 participants).
Report a problemFND-4262855502
04HumanRandomized controlled trialEfficacy outcome
In US adults with obesity or overweight without type 2 diabetes, mazdutide 16 mg reduced body weight more than placebo at week 32 (-18.1% versus -0.9%).
In plain wordsIn US adults with obesity or overweight and no type 2 diabetes, mazdutide 16 mg lowered body weight more than placebo after 32 weeks.
Peptide
Mazdutide
Outcome
DecreasePercent body weight change at week 32 (16 mg)
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
16 mg · subcutaneous · 32 weeksAs given in this study (human).
Measurements
Body weight change
−18.1%
mazdutide 16 mg
Body weight change
−0.9%
placebo
Source sentences
Summary
At 32 weeks, the least-squares mean percentage change from baseline in bodyweight was -7·3% (SE 0·9) with mazdutide 3-6 mg, -15·6% (0·7) with 10 mg, and -18·1% (1·0) with 16 mg, versus -0·9% (0·8) with placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
We aimed to evaluate the efficacy, safety, and tolerability of once-weekly mazdutide across a dose range up to 16 mg in adults with obesity or overweight without type 2 diabetes in the USA.
Summary · context
Between Nov 17, 2023, and July 9, 2025, 179 participants were randomly allocated to receive mazdutide (32 participants to 3-6 mg, 48 to 10 mg, and 51 to 16 mg) or placebo (48 participants).
Report a problemFND-4262855503
05HumanRandomized controlled trialEfficacy outcome
In US adults with obesity or overweight without type 2 diabetes, additional body weight reductions with mazdutide were observed at 48 weeks.
In plain wordsIn US adults with obesity or overweight and no type 2 diabetes, people on mazdutide lost further weight by 48 weeks.
Peptide
Mazdutide
Outcome
DecreaseBody weight reduction at week 48
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Studied dose
3-6 mg, 10 mg and 16 mg · subcutaneous · 48 weeksAs given in this study (human).
Source sentences
Summary
Additional bodyweight reductions were observed at 48 weeks.
2 context sentences(design, population, supporting numbers)
Summary · context
We aimed to evaluate the efficacy, safety, and tolerability of once-weekly mazdutide across a dose range up to 16 mg in adults with obesity or overweight without type 2 diabetes in the USA.
Summary · context
Between Nov 17, 2023, and July 9, 2025, 179 participants were randomly allocated to receive mazdutide (32 participants to 3-6 mg, 48 to 10 mg, and 51 to 16 mg) or placebo (48 participants).
Report a problemFND-4262855505
06HumanRandomized controlled trialSafety outcome
In US adults with obesity or overweight, the most common adverse events with mazdutide were gastrointestinal and mostly mild to moderate.
In plain wordsIn US adults with obesity or overweight, the most common side effects of mazdutide were stomach and gut problems, mostly mild to moderate.
Peptide
Mazdutide
Outcome
Direction not reportedGastrointestinal adverse events
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3-6 mg, 10 mg and 16 mg · subcutaneous · 48 weeksAs given in this study (human).
Source sentences
Summary
The most common adverse events with mazdutide were gastrointestinal-related and mostly mild to moderate in severity
2 context sentences(design, population, supporting numbers)
Summary · context
We aimed to evaluate the efficacy, safety, and tolerability of once-weekly mazdutide across a dose range up to 16 mg in adults with obesity or overweight without type 2 diabetes in the USA.
Summary · context
Between Nov 17, 2023, and July 9, 2025, 179 participants were randomly allocated to receive mazdutide (32 participants to 3-6 mg, 48 to 10 mg, and 51 to 16 mg) or placebo (48 participants).
Report a problemFND-4262855506
07HumanRandomized controlled trialSafety outcome
In US adults with obesity or overweight, discontinuation due to adverse events occurred most often with mazdutide 16 mg (20%), mainly from gastrointestinal disorders.
In plain wordsIn US adults with obesity or overweight, stopping treatment for side effects was most common with mazdutide 16 mg, mainly stomach and gut problems.
Peptide
Mazdutide
Outcome
Direction not reportedDiscontinuation due to adverse events (16 mg)
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
16 mg · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Discontinuation due to adverse events
20%
mazdutide 16 mg
Source sentences
Summary
discontinuation of study treatment due to adverse events occurred most frequently with 16 mg (20%), associated primarily with gastrointestinal disorders.
2 context sentences(design, population, supporting numbers)
Summary · context
We aimed to evaluate the efficacy, safety, and tolerability of once-weekly mazdutide across a dose range up to 16 mg in adults with obesity or overweight without type 2 diabetes in the USA.
Summary · context
Between Nov 17, 2023, and July 9, 2025, 179 participants were randomly allocated to receive mazdutide (32 participants to 3-6 mg, 48 to 10 mg, and 51 to 16 mg) or placebo (48 participants).
Report a problemFND-4262855507

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 2Results postedNCT06124807

A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight

Eli Lilly and Companyn = 17917 Nov 2023 to 9 Jul 2025

Obesity · Overweight and Obesity

Trial page ClinicalTrials.govUpdated 21 Apr 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, 02:47 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

Journal Article

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