A Study of IBI362 in Chinese Adolescents With Obesity or Overweight

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Adolescents With Obesity or Overweight With Weight-Related Comorbidities

In brief

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.

Key facts

Study ID

NCT07255209

Run by

Innovent Biologics (Suzhou) Co. Ltd.

People needed

180

Starts

2025-12-29

Expected to finish

2028-10-31

Last updated by the study team

2026-01-08

Who can join

Age: 12 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must meet all of the following inclusion criteria to be enrolled:
• Key Inclusion Criteria：
• 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).

You may not qualify if…

• Key Exclusion Criteria：
• 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).

Where it is running

• The Children's Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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