A phase 2 randomised controlled trial of mazdutide in Chinese overweight adults or adults with obesity.

Ji L, Jiang H, Cheng Z, Qiu W, Liao L, Zhang Y, Li X, Pang S, Zhang L, Chen L, Yang T, Li Y and 9 more

Show all authors

Qu S, Wen J, Gu J, Deng H, Wang Y, Li L, Han-Zhang H, Ma Q, Qian L

Nature communications14 Dec 2023Cited by 86 (Europe PMC)

PMID38092790PMCIDPMC10719339DOI10.1038/s41467-023-44067-4PepBankPUB-38092790

Download PDF PubMedAsk about this study

Jump to 6 results

Summary

Mazdutide is a once-weekly glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist. We evaluated the efficacy and safety of 24-week treatment of mazdutide up to 6 mg in Chinese overweight adults or adults with obesity, as an interim analysis of a randomised, two-part (low doses up to 6 mg and high dose of 9 mg), double-blind, placebo-controlled phase 2 trial (ClinicalTrials.gov, NCT04904913). Overweight adults (body-mass index [BMI] ≥24 kg/m²) accompanied by hyperphagia and/or at least one obesity-related comorbidity or adults with obesity (BMI ≥ 28 kg/m²) were randomly assigned (3:1:3:1:3:1) to once-weekly mazdutide 3 mg, 4.5 mg, 6 mg or matching placebo at 20 hospitals in China. The primary endpoint was the percentage change from baseline to week 24 in body weight. A total of 248 participants were randomised to mazdutide 3 mg (n = 62), 4.5 mg (n = 63), 6 mg (n = 61) or placebo (n = 62). The mean percentage changes from baseline to week 24 in body weight were -6.7% (SE 0.7) with mazdutide 3 mg, -10.4% (0.7) with 4.5 mg, -11.3% (0.7) with 6 mg and 1.0% (0.7) with placebo, with treatment difference versus placebo ranging from -7.7% to -12.3% (all p < 0.0001). All mazdutide doses were well tolerated and the most common adverse events included diarrhoea, nausea and upper respiratory tract infection. In summary, in Chinese overweight adults or adults with obesity, 24-week treatment with mazdutide up to 6 mg was safe and led to robust and clinically meaningful body weight reduction.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

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

01HumanRandomized controlled trialEfficacy outcome
In Chinese overweight adults or adults with obesity, mazdutide 4.5 mg reduced body weight by 10.4% at week 24, compared with a 1.0% increase with placebo.
In plain wordsIn Chinese adults with overweight or obesity, mazdutide 4.5 mg lowered body weight, while weight rose slightly with placebo.
Peptide
Mazdutide
Outcome
DecreaseBody weight percentage change at week 24, 4.5 mg
Study
n = 63
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
4.5 mg · 24 weeksAs given in this study (human).
Measurements
Body weight change
−10.4%
mazdutide 4.5 mg
Body weight change
1%
placebo
Source sentences
Summary
The mean percentage changes from baseline to week 24 in body weight were -6.7% (SE 0.7) with mazdutide 3 mg, -10.4% (0.7) with 4.5 mg, -11.3% (0.7) with 6 mg and 1.0% (0.7) with placebo, with treatment difference versus placebo ranging from -7.7% to -12.3% (all p < 0.0001).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint was the percentage change from baseline to week 24 in body weight.
Summary · context
Overweight adults (body-mass index [BMI] ≥24 kg/m²) accompanied by hyperphagia and/or at least one obesity-related comorbidity or adults with obesity (BMI ≥ 28 kg/m²) were randomly assigned (3:1:3:1:3:1) to once-weekly mazdutide 3 mg, 4.5 mg, 6 mg or matching placebo at 20 hospitals in China.
Summary · context
A total of 248 participants were randomised to mazdutide 3 mg (n = 62), 4.5 mg (n = 63), 6 mg (n = 61) or placebo (n = 62).
Show in the study text Report a problemFND-3809279002
02HumanRandomized controlled trialEfficacy outcome
In Chinese overweight adults or adults with obesity, mazdutide 3 mg reduced body weight by 6.7% at week 24, compared with a 1.0% increase with placebo.
In plain wordsIn Chinese adults with overweight or obesity, mazdutide 3 mg lowered body weight, while weight rose slightly with placebo.
Peptide
Mazdutide
Outcome
DecreaseBody weight percentage change at week 24, 3 mg
Study
n = 62
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
3 mg · 24 weeksAs given in this study (human).
Measurements
Body weight change
−6.7%
mazdutide 3 mg
Body weight change
1%
placebo
Source sentences
Summary
The mean percentage changes from baseline to week 24 in body weight were -6.7% (SE 0.7) with mazdutide 3 mg, -10.4% (0.7) with 4.5 mg, -11.3% (0.7) with 6 mg and 1.0% (0.7) with placebo, with treatment difference versus placebo ranging from -7.7% to -12.3% (all p < 0.0001).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint was the percentage change from baseline to week 24 in body weight.
Summary · context
Overweight adults (body-mass index [BMI] ≥24 kg/m²) accompanied by hyperphagia and/or at least one obesity-related comorbidity or adults with obesity (BMI ≥ 28 kg/m²) were randomly assigned (3:1:3:1:3:1) to once-weekly mazdutide 3 mg, 4.5 mg, 6 mg or matching placebo at 20 hospitals in China.
Summary · context
A total of 248 participants were randomised to mazdutide 3 mg (n = 62), 4.5 mg (n = 63), 6 mg (n = 61) or placebo (n = 62).
Show in the study text Report a problemFND-3809279001
03HumanRandomized controlled trialEfficacy outcome
In Chinese overweight adults or adults with obesity, mazdutide 6 mg reduced body weight by 11.3% at week 24, compared with a 1.0% increase with placebo.
In plain wordsIn Chinese adults with overweight or obesity, mazdutide 6 mg lowered body weight, while weight rose slightly with placebo.
Peptide
Mazdutide
Outcome
DecreaseBody weight percentage change at week 24, 6 mg
Study
n = 61
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
6 mg · 24 weeksAs given in this study (human).
Measurements
Body weight change
−11.3%
mazdutide 6 mg
Body weight change
1%
placebo
Source sentences
Summary
The mean percentage changes from baseline to week 24 in body weight were -6.7% (SE 0.7) with mazdutide 3 mg, -10.4% (0.7) with 4.5 mg, -11.3% (0.7) with 6 mg and 1.0% (0.7) with placebo, with treatment difference versus placebo ranging from -7.7% to -12.3% (all p < 0.0001).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint was the percentage change from baseline to week 24 in body weight.
Summary · context
Overweight adults (body-mass index [BMI] ≥24 kg/m²) accompanied by hyperphagia and/or at least one obesity-related comorbidity or adults with obesity (BMI ≥ 28 kg/m²) were randomly assigned (3:1:3:1:3:1) to once-weekly mazdutide 3 mg, 4.5 mg, 6 mg or matching placebo at 20 hospitals in China.
Summary · context
A total of 248 participants were randomised to mazdutide 3 mg (n = 62), 4.5 mg (n = 63), 6 mg (n = 61) or placebo (n = 62).
Show in the study text Report a problemFND-3809279003
04HumanRandomized controlled trialSafety outcome
In Chinese overweight adults or adults with obesity, diarrhoea was among the most common adverse events with mazdutide, which was well tolerated at all doses.
In plain wordsIn Chinese adults with overweight or obesity, diarrhoea was a common side effect of mazdutide, which was well tolerated.
Peptide
Mazdutide
Outcome
Not applicableDiarrhoea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3 mg, 4.5 mg or 6 mg · 24 weeksAs given in this study (human).
Source sentences
Summary
All mazdutide doses were well tolerated and the most common adverse events included diarrhoea, nausea and upper respiratory tract infection.
2 context sentences(design, population, supporting numbers)
Summary · context
Overweight adults (body-mass index [BMI] ≥24 kg/m²) accompanied by hyperphagia and/or at least one obesity-related comorbidity or adults with obesity (BMI ≥ 28 kg/m²) were randomly assigned (3:1:3:1:3:1) to once-weekly mazdutide 3 mg, 4.5 mg, 6 mg or matching placebo at 20 hospitals in China.
Summary · context
A total of 248 participants were randomised to mazdutide 3 mg (n = 62), 4.5 mg (n = 63), 6 mg (n = 61) or placebo (n = 62).
Show in the study text Report a problemFND-3809279004
05HumanRandomized controlled trialSafety outcome
In Chinese overweight adults or adults with obesity, nausea was among the most common adverse events with mazdutide, which was well tolerated at all doses.
In plain wordsIn Chinese adults with overweight or obesity, nausea was a common side effect of mazdutide, which was well tolerated.
Peptide
Mazdutide
Outcome
Not applicableNausea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3 mg, 4.5 mg or 6 mg · 24 weeksAs given in this study (human).
Source sentences
Summary
All mazdutide doses were well tolerated and the most common adverse events included diarrhoea, nausea and upper respiratory tract infection.
2 context sentences(design, population, supporting numbers)
Summary · context
Overweight adults (body-mass index [BMI] ≥24 kg/m²) accompanied by hyperphagia and/or at least one obesity-related comorbidity or adults with obesity (BMI ≥ 28 kg/m²) were randomly assigned (3:1:3:1:3:1) to once-weekly mazdutide 3 mg, 4.5 mg, 6 mg or matching placebo at 20 hospitals in China.
Summary · context
A total of 248 participants were randomised to mazdutide 3 mg (n = 62), 4.5 mg (n = 63), 6 mg (n = 61) or placebo (n = 62).
Show in the study text Report a problemFND-3809279005
06HumanRandomized controlled trialSafety outcome
In Chinese overweight adults or adults with obesity, upper respiratory tract infection was among the most common adverse events with mazdutide.
In plain wordsIn Chinese adults with overweight or obesity, upper respiratory tract infection was a common adverse event in people on mazdutide.
Peptide
Mazdutide
Outcome
Not applicableUpper respiratory tract infection
Study
n: not reported in source
Outcome group
Adverse events · Respiratory
Studied dose
3 mg, 4.5 mg or 6 mg · 24 weeksAs given in this study (human).
Source sentences
Summary
All mazdutide doses were well tolerated and the most common adverse events included diarrhoea, nausea and upper respiratory tract infection.
2 context sentences(design, population, supporting numbers)
Summary · context
Overweight adults (body-mass index [BMI] ≥24 kg/m²) accompanied by hyperphagia and/or at least one obesity-related comorbidity or adults with obesity (BMI ≥ 28 kg/m²) were randomly assigned (3:1:3:1:3:1) to once-weekly mazdutide 3 mg, 4.5 mg, 6 mg or matching placebo at 20 hospitals in China.
Summary · context
A total of 248 participants were randomised to mazdutide 3 mg (n = 62), 4.5 mg (n = 63), 6 mg (n = 61) or placebo (n = 62).
Show in the study text Report a problemFND-3809279006

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

Registered trials2

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

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

Not yet recruitingPhase 4NCT07654062

Mazdutide for Adults With Prediabetes: A Randomized, Double-Blind, Placebo-Controlled Trial (DREAM-PRE)

Shandong Provincial Hospitaln = 150est. Jul 2026 to est. Jul 2029

Prediabetes · Impaired Fasting Glucose · Impaired Glucose Tolerance (Prediabetes)

Trial page ClinicalTrials.govUpdated 17 Jun 2026

CompletedPhase 2NCT04904913

A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects

Innovent Biologics (Suzhou) Co. Ltd.n = 3288 Jun 2021 to 6 Dec 2023

Overweight/ Obesity

Trial page ClinicalTrials.govUpdated 17 Nov 2025

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

MeSH terms

PepBank is a research reference. Talk to a doctor before you use any peptide.