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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT04904913 (opens ClinicalTrials.gov in a new tab)Other idCIBI362B201
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
328 participants (actual)
Sponsor
Innovent Biologics (Suzhou) Co. Ltd. · Industry
Design
Randomized · Double masking
Countries
1 country

China

Start
8 Jun 2021
Primary completion
29 Mar 2023
Completion
6 Dec 2023
First posted
27 May 2021
Last update posted
17 Nov 2025
Conditions
Overweight/ Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2021202220232024
  1. Ph 2

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

    NCT04904913

    8 Jun 2021 to 6 Dec 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a multicenter, double-blind, randomized, placebo-controlled study conducted in overweight or obese subjects. This study is divided into the first stage and the second stage. The participant enrollment and data analysis in the two stage are independent and do not influence each other. In the first stage of this study, about 240 subjects will be enrolled. Qualified subjects will receive placebo in a 2-week introduction period, after that, they will be randomized to IBI362 low dose, IBI362 moderate dose, IBI362 high dose groups, in every group, subjects will be randomized to IBI362 and placebo groups at a ratio of 3:1. Random stratification is performed based on BMI \< 28.0 kg/㎡ and BMI≥28.0 kg/㎡. The subjects received drug administration once weekly. The entire trial covers a 3-week screening period, a 2-week placebo introduction period, a-24 week double-blind treatment period, and a 12-week drug discontinuation follow-up period. During the entire research period, the subjects shall maintain diet and exercise control. The second stage is IBI362 extra high dose study, about 80 subjects will be enrolled. Qualified participants will receive placebo in a 2-week introduction period, after that, they will be randomized to IBI362 extra high dose and placebo groups at a ratio of 3:1. The subjects received drug administration once weekly. The entire trial covers a 3-week screening period, a 2-week placebo introduction period, a 24-week double-blind treatment period, a 24-week extended treatment period, and a 12-week drug discontinuation follow-up period. The 24-week extended treatment period is optional. During the entire research period, the subjects shall maintain diet and exercise control.

Interventions

  • IBI362Drug
  • placeboOther

Arms5

  • Experimental

    IBI362 high dose

    high dose IBI362 administered subcutaneously (SC) once a week.

  • Experimental

    IBI362 low dose

    Low dose IBI362 administered subcutaneously (SC) once a week.

  • Placebo comparator

    placebo

    placebo administered subcutaneously (SC) once a week.

  • Experimental

    IBI362 moderate dose

    moderate dose IBI362 administered subcutaneously (SC) once a week.

  • Experimental

    IBI362 extra high dose

    extra high dose IBI362 administered subcutaneously (SC) once a week.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent Change from Baseline in Body Weight

    Time frame · Baseline ,week 24

    Registry description

    Percent Change from Baseline in Body Weight

Secondary outcomes(15)

  1. Percentage of Participants who Achieve ≥5% Body Weight Reduction

    Time frame · Baseline, Week 24

  2. Percentage of Participants who Achieve ≥10% Body Weight Reduction

    Time frame · Baseline, Week 24

  3. Absolute change from Baseline in body weight

    Time frame · Baseline, Week 24

  4. Change from Baseline in Waist Circumference

    Time frame · Baseline, Week 24

  5. Change from Baseline in BMI

    Time frame · Baseline, Week 24

  6. Change from Baseline in HbA1c

    Time frame · Baseline, Week 24

  7. Change from Baseline in fasting plasma glucose

    Time frame · Baseline, Week 24

  8. Change from Baseline in systolic blood pressure

    Time frame · Baseline, Week 24

  9. Change from Baseline in diastolic blood pressure

    Time frame · Baseline, Week 24

  10. Change from Baseline in total cholesterol

    Time frame · Baseline, Week 24

  11. Change from Baseline in low-density lipoprotein cholesterol

    Time frame · Baseline, Week 24

  12. Change from Baseline in high-density lipoprotein cholesterol

    Time frame · Baseline, Week 24

  13. Change from Baseline in triglyceride

    Time frame · Baseline, Week 24

  14. Change from Baseline in serum uric acid

    Time frame · Baseline, Week 12, Week 24

  15. Change from Baseline in IWQoL-Lite-CT questionnaire scores

    Time frame · Baseline, Week 24

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2026

6 results

Mazdutide 9 mg in Chinese adults with a body mass index ≥30 kg/m2 but without diabetes: A phase 2 randomized controlled trial.

Ji et al. 2026Med (New York, N.Y.)cited by 3

PMID 41875890DOI 10.1016/j.medj.2026.101063PUB-41875890

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: Randomized controlled trial · 2023

6 results

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

Ji et al. 2023Nature communicationscited by 86

PMID 38092790PMC10719339DOI 10.1038/s41467-023-44067-4PUB-38092790

CC BY6 results
Download PDFSee results (6)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. The first stage: Body mass Index (BMI) ≥28 kilograms per square meter (kg/m²), or ≥24 kg/m² with at least one of the following comorbidities: hyperphagia, pre-diabetes, hypertension, dyslipidemia, fatty liver disease, weight-bearing joint pain, obesity-induced dyspnea or obstructive sleep apnea syndrome; The second stage: Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²) 2. The weight change of the subjects before and after the introduction period was less than 5.0% Exclusion Criteria: 1. Diabetes mellitus 2. Weight change \> 5.0% after diet and exercise control for at least 12 weeks before screening 3. Have used or are currently using weight loss drugs within 3 months before screening 4. History of pancreatitis 5. Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) 6. History of moderate to severe depression，or have a history of serious mental illness 7. Any lifetime history of a suicide attempt

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