ODP014 Safety and Efficacy of IBI362 (LY3305677) 9 mg and 10 mg in Chinese Adults with Overweight or Obesity

The source lists no authors.

Journal of the Endocrine Society1 Nov 2022

PMCIDPMC9624873PepBankPUB-95172054

Read at source Source pageAsk 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: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study13

13 results from studies that gave the peptide. 13 results from people.

01HumanRandomized controlled trialSafety outcome
In Chinese adults with overweight or obesity, no serious adverse event was reported with IBI362 at 9 mg and 10 mg.
In plain wordsIn Chinese adults with overweight or obesity, no serious side effects were reported with IBI362 (mazdutide) at these doses.
Peptide
Mazdutide
Outcome
No significant changeSerious adverse events
Study
n = 24
Comparator
Placebo
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
9 mg and 10 mg cohorts · subcutaneous · 12 to 16 weeksAs given in this study (human).
Source sentences
Summary
No serious adverse event (AE) was reported
2 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoints were safety and tolerability of IBI362.
Summary · context
Two high-dose cohorts from a randomized, placebo-controlled, multiple ascending dose study (NCT04440345) enrolled adults with overweight (body mass index [BMI] ≥24 kg/m 2) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m 2) from five study centers in China.
Report a problemFND-9517205407
02HumanRandomized controlled trialSafety outcome
In Chinese adults with overweight or obesity, all adverse events with IBI362 were mild or moderate in severity.
In plain wordsIn Chinese adults with overweight or obesity, all side effects during IBI362 (mazdutide) treatment were mild or moderate.
Peptide
Mazdutide
Outcome
Not applicableSeverity of adverse events
Study
n = 24
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
9 mg and 10 mg cohorts · subcutaneous · 12 to 16 weeksAs given in this study (human).
Source sentences
Summary
all AEs were mild or moderate in severity.
2 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoints were safety and tolerability of IBI362.
Summary · context
Two high-dose cohorts from a randomized, placebo-controlled, multiple ascending dose study (NCT04440345) enrolled adults with overweight (body mass index [BMI] ≥24 kg/m 2) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m 2) from five study centers in China.
Report a problemFND-9517205408
03HumanRandomized controlled trialEfficacy outcome
In Chinese adults with overweight or obesity, waist circumference was markedly decreased in participants receiving IBI362.
In plain wordsIn Chinese adults with overweight or obesity, waist size decreased markedly in people receiving IBI362 (mazdutide).
Peptide
Mazdutide
Outcome
DecreaseWaist circumference change
Study
n = 24
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
9 mg and 10 mg cohorts · subcutaneous · 12 to 16 weeksAs given in this study (human).
Source sentences
Summary
In addition, waist circumference and BMI were markedly decreased in participants receiving IBI362.
2 context sentences(design, population, supporting numbers)
Summary · context
The secondary endpoints included changes from baseline in body weight, waist circumference and BMI.
Summary · context
Two high-dose cohorts from a randomized, placebo-controlled, multiple ascending dose study (NCT04440345) enrolled adults with overweight (body mass index [BMI] ≥24 kg/m 2) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m 2) from five study centers in China.
Report a problemFND-9517205405
04HumanRandomized controlled trialEfficacy outcome
In Chinese adults with overweight or obesity, BMI was markedly decreased in participants receiving IBI362.
In plain wordsIn Chinese adults with overweight or obesity, BMI decreased markedly in people receiving IBI362 (mazdutide).
Peptide
Mazdutide
Outcome
DecreaseBody mass index change
Study
n = 24
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
9 mg and 10 mg cohorts · subcutaneous · 12 to 16 weeksAs given in this study (human).
Source sentences
Summary
In addition, waist circumference and BMI were markedly decreased in participants receiving IBI362.
2 context sentences(design, population, supporting numbers)
Summary · context
The secondary endpoints included changes from baseline in body weight, waist circumference and BMI.
Summary · context
Two high-dose cohorts from a randomized, placebo-controlled, multiple ascending dose study (NCT04440345) enrolled adults with overweight (body mass index [BMI] ≥24 kg/m 2) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m 2) from five study centers in China.
Report a problemFND-9517205406
05HumanRandomized controlled trialEfficacy outcome
In Chinese adults with overweight or obesity, IBI362 in the 9 mg cohort reduced body weight by 11.7% at week 12, compared with 1.8% with placebo.
In plain wordsIn Chinese adults with overweight or obesity, IBI362 (mazdutide) up to 9 mg lowered body weight more than placebo after 12 weeks.
Peptide
Mazdutide
Outcome
DecreaseBody weight percentage change at week 12, 9 mg cohort
Study
n = 12
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
9 mg (escalation 3 mg, 6 mg, 9 mg) · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Body weight change
−11.7%
IBI362 9 mg cohort
Body weight change
−1.8%
placebo
Estimated treatment difference
−9.8%
IBI362 9 mg vs placebo
Source sentences
Summary
Mean percent changes from baseline to week 12 in body weight were−11.7% for participants receiving IBI362 in the 9 mg cohort and−1.8% for participants receiving placebo (estimated treatment difference [ETD]: −9.8%; 95% confidence interval (CI): −14.4,−5.3; P = 0. 0002).
2 context sentences(design, population, supporting numbers)
Summary · context
The secondary endpoints included changes from baseline in body weight, waist circumference and BMI.
Summary · context
Two high-dose cohorts from a randomized, placebo-controlled, multiple ascending dose study (NCT04440345) enrolled adults with overweight (body mass index [BMI] ≥24 kg/m 2) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m 2) from five study centers in China.
Report a problemFND-9517205401
06HumanRandomized controlled trialEfficacy outcome
In Chinese adults with overweight or obesity, IBI362 in the 10 mg cohort reduced body weight by 9.5% at week 16, compared with 3.3% with placebo.
In plain wordsIn Chinese adults with overweight or obesity, IBI362 (mazdutide) up to 10 mg lowered body weight more than placebo after 16 weeks.
Peptide
Mazdutide
Outcome
DecreaseBody weight percentage change at week 16, 10 mg cohort
Study
n = 12
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
10 mg (escalation 2.5 mg, 5 mg, 7.5 mg, 10 mg) · subcutaneous · 16 weeksAs given in this study (human).
Measurements
Body weight change
−9.5%
IBI362 10 mg cohort
Body weight change
−3.3%
placebo
Estimated treatment difference
−6.2%
IBI362 10 mg vs placebo
Source sentences
Summary
Mean percent changes from baseline to week 16 in body weight were−9.5% for participants receiving IBI362 in the 10 mg cohort and−3.3% for participants receiving placebo (ETD: −6.2%; 95% CI: −11.5,−0.9; P = 0. 0243).
2 context sentences(design, population, supporting numbers)
Summary · context
The secondary endpoints included changes from baseline in body weight, waist circumference and BMI.
Summary · context
Two high-dose cohorts from a randomized, placebo-controlled, multiple ascending dose study (NCT04440345) enrolled adults with overweight (body mass index [BMI] ≥24 kg/m 2) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m 2) from five study centers in China.
Report a problemFND-9517205402
07HumanRandomized controlled trialEfficacy outcome
In Chinese adults with overweight or obesity, 4 participants (50%) on IBI362 in each cohort achieved weight loss of 10% or more.
In plain wordsIn Chinese adults with overweight or obesity, half of the people on IBI362 (mazdutide) in each group lost at least 10% of body weight.
Peptide
Mazdutide
Outcome
IncreaseShare with weight loss of 10% or more
Study
n = 16
Outcome group
Body weight · Metabolic and weight
Studied dose
9 mg and 10 mg cohorts · subcutaneous · 12 to 16 weeksAs given in this study (human).
Measurements
Participants with weight loss of 10% or more
50%
IBI362 each cohort
Source sentences
Summary
Four participants (50%) receiving IBI362 in each cohort achieved≥10% weight loss
1 context sentence(design, population, supporting numbers)
Summary · context
Two high-dose cohorts from a randomized, placebo-controlled, multiple ascending dose study (NCT04440345) enrolled adults with overweight (body mass index [BMI] ≥24 kg/m 2) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m 2) from five study centers in China.
Report a problemFND-9517205403
08HumanRandomized controlled trialEfficacy outcome
In Chinese adults with overweight or obesity, 2 participants (25%) on IBI362 in each cohort achieved weight loss of 15% or more.
In plain wordsIn Chinese adults with overweight or obesity, one quarter of the people on IBI362 (mazdutide) in each group lost at least 15% of body weight.
Peptide
Mazdutide
Outcome
IncreaseShare with weight loss of 15% or more
Study
n = 16
Outcome group
Body weight · Metabolic and weight
Studied dose
9 mg and 10 mg cohorts · subcutaneous · 12 to 16 weeksAs given in this study (human).
Measurements
Participants with weight loss of 15% or more
25%
IBI362 each cohort
Source sentences
Summary
two (25%) receiving IBI362 in each cohort achieved≥15% weight loss
1 context sentence(design, population, supporting numbers)
Summary · context
Two high-dose cohorts from a randomized, placebo-controlled, multiple ascending dose study (NCT04440345) enrolled adults with overweight (body mass index [BMI] ≥24 kg/m 2) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m 2) from five study centers in China.
Report a problemFND-9517205404
09HumanRandomized controlled trialSafety outcome
In Chinese adults with overweight or obesity, diarrhea was reported in six participants (37.5%) receiving IBI362.
In plain wordsIn Chinese adults with overweight or obesity, diarrhea was reported by 37.5% of people receiving IBI362 (mazdutide).
Peptide
Mazdutide
Outcome
Not applicableDiarrhea
Study
n = 16
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
9 mg and 10 mg cohorts · subcutaneous · 12 to 16 weeksAs given in this study (human).
Measurements
Incidence
37.5%
IBI362
Source sentences
Summary
The most commonly-reported AEs included diarrhea, nausea, vomiting and decreased appetite (each reported in six participants [37.5%] receiving IBI362).
1 context sentence(design, population, supporting numbers)
Summary · context
Two high-dose cohorts from a randomized, placebo-controlled, multiple ascending dose study (NCT04440345) enrolled adults with overweight (body mass index [BMI] ≥24 kg/m 2) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m 2) from five study centers in China.
Report a problemFND-9517205409
10HumanRandomized controlled trialSafety outcome
In Chinese adults with overweight or obesity, nausea was reported in six participants (37.5%) receiving IBI362.
In plain wordsIn Chinese adults with overweight or obesity, nausea was reported by 37.5% of people receiving IBI362 (mazdutide).
Peptide
Mazdutide
Outcome
Not applicableNausea
Study
n = 16
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
9 mg and 10 mg cohorts · subcutaneous · 12 to 16 weeksAs given in this study (human).
Measurements
Incidence
37.5%
IBI362
Source sentences
Summary
The most commonly-reported AEs included diarrhea, nausea, vomiting and decreased appetite (each reported in six participants [37.5%] receiving IBI362).
1 context sentence(design, population, supporting numbers)
Summary · context
Two high-dose cohorts from a randomized, placebo-controlled, multiple ascending dose study (NCT04440345) enrolled adults with overweight (body mass index [BMI] ≥24 kg/m 2) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m 2) from five study centers in China.
Report a problemFND-9517205410
11HumanRandomized controlled trialSafety outcome
In Chinese adults with overweight or obesity, vomiting was reported in six participants (37.5%) receiving IBI362.
In plain wordsIn Chinese adults with overweight or obesity, vomiting was reported by 37.5% of people receiving IBI362 (mazdutide).
Peptide
Mazdutide
Outcome
Not applicableVomiting
Study
n = 16
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
9 mg and 10 mg cohorts · subcutaneous · 12 to 16 weeksAs given in this study (human).
Measurements
Incidence
37.5%
IBI362
Source sentences
Summary
The most commonly-reported AEs included diarrhea, nausea, vomiting and decreased appetite (each reported in six participants [37.5%] receiving IBI362).
1 context sentence(design, population, supporting numbers)
Summary · context
Two high-dose cohorts from a randomized, placebo-controlled, multiple ascending dose study (NCT04440345) enrolled adults with overweight (body mass index [BMI] ≥24 kg/m 2) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m 2) from five study centers in China.
Report a problemFND-9517205411
12HumanRandomized controlled trialSafety outcome
In Chinese adults with overweight or obesity, decreased appetite was reported in six participants (37.5%) receiving IBI362.
In plain wordsIn Chinese adults with overweight or obesity, decreased appetite was reported by 37.5% of people receiving IBI362 (mazdutide).
Peptide
Mazdutide
Outcome
Not applicableDecreased appetite
Study
n = 16
Outcome group
Adverse events · Whole body
Studied dose
9 mg and 10 mg cohorts · subcutaneous · 12 to 16 weeksAs given in this study (human).
Measurements
Incidence
37.5%
IBI362
Source sentences
Summary
The most commonly-reported AEs included diarrhea, nausea, vomiting and decreased appetite (each reported in six participants [37.5%] receiving IBI362).
1 context sentence(design, population, supporting numbers)
Summary · context
Two high-dose cohorts from a randomized, placebo-controlled, multiple ascending dose study (NCT04440345) enrolled adults with overweight (body mass index [BMI] ≥24 kg/m 2) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m 2) from five study centers in China.
Report a problemFND-9517205412
13HumanRandomized controlled trialSafety outcome
In the 10 mg cohort, one participant receiving IBI362 and two receiving placebo withdrew consent and left the study.
In plain wordsIn the 10 mg group, one person on IBI362 (mazdutide) and two on placebo withdrew consent and left the study.
Peptide
Mazdutide
Outcome
Not applicableWithdrawal of consent
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
10 mg cohort · subcutaneous · 16 weeksAs given in this study (human).
Source sentences
Summary
One participant receiving IBI362 and two receiving placebo in the 10 mg cohort withdrew consent and quitted the study.
1 context sentence(design, population, supporting numbers)
Summary · context
Two high-dose cohorts from a randomized, placebo-controlled, multiple ascending dose study (NCT04440345) enrolled adults with overweight (body mass index [BMI] ≥24 kg/m 2) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m 2) from five study centers in China.
Report a problemFND-9517205413

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.

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

Abstract

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