RecruitingPhase 3NCT07255209

A Study of IBI362 in Chinese Adolescents With Obesity or Overweight

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)


Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Enrollment

180 participants

Start Date

Dec 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 12 YearsMax Age: 18 Years

Inclusion Criteria3

  • Male or female participants aged ≥12 years and <18 years at the time of signing the informed consent/assent form.
  • 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.
  • Weight change <5 kg after ≥12 weeks of diet and exercise alone before screening (per self/parental report).

Exclusion Criteria3

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

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Interventions

DRUGPlacebo

Placebo SA.QW

DRUGIBI362

IBI362 SA.QW


Locations(1)

The Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT07255209