A Study of IBI362 in Chinese Adolescents With Obesity or Overweight

January 7, 2026 updated by: Innovent Biologics (Suzhou) Co. Ltd.

A Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of IBI362 in Chinese Adolescents With Obesity or Overweight（GLORY-YOUNG）

The study is designed to assess the efficacy and safety of multiple doses of IBI362 in Chinese adolescent subjects with obesity or overweight. It plans to enroll 180 adolescents (aged ≥12 and <18 years) who have failed to achieve a 5 kg weight reduction after at least 12 weeks of dietary and exercise intervention.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310052
        • Recruiting
        • The Children's Hospital, Zhejiang University School of Medicine
        • Contact:
        • Principal Investigator:
          • Junfen Fu, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants must meet all of the following inclusion criteria to be enrolled:

Key Inclusion Criteria：

  1. Male or female participants aged ≥12 years and <18 years at the time of signing the informed consent/assent form.
  2. BMI at screening meeting the obesity criteria defined by "WS/T 586-2018 Screening for Overweight and Obesity in School-Age Children and Adolescents" or meeting overweight criteria plus at least one weight-related comorbidity: prediabetes, type 2 diabetes, hypertension, dyslipidemia, fatty liver disease, or obstructive sleep apnea syndrome.
  3. Weight change <5 kg after ≥12 weeks of diet and exercise alone before screening (per self/parental report).

Exclusion Criteria:

Key Exclusion Criteria：

  1. Prior diagnosis of type 1 diabetes.
  2. Pre-pubertal participants (Tanner Stage I).
  3. History of (or planned) bariatric surgery (except liposuction/abdominoplasty or acupuncture for weight loss performed >1 year before screening).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo SA.QW
Experimental: IBI362-dose2
Drug: IBI362
IBI362 SA.QW
Experimental: IBI362-dose1
Drug: IBI362
IBI362 SA.QW

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in BMI
Time Frame: Week 32
Week 32

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with ≥5% BMI Reduction
Time Frame: Week 32
Week 32
Percent Change from Baseline in BMI
Time Frame: Week 52
Week 52
Percentage of Participants with ≥5% BMI Reduction
Time Frame: Week 52
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2028

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Estimated)

November 28, 2025

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBI362B304

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adolescents With Obesity or Overweight With Weight-Related Comorbidities

Clinical Trials on IBI362

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe