IBI362 for weight loss in Chinese adolescents with obesity or overweight

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial plans to enroll about 180 Chinese adolescents aged 12 to under 18 who have not lost at least 5 kg after at least 12 weeks of diet and exercise. Eligible participants meet national criteria for obesity or are overweight with at least one weight-related comorbidity and will receive one of multiple doses of IBI362 or placebo. Participants will be monitored for changes in body weight and for safety outcomes throughout the treatment period. Key exclusions include prior type 1 diabetes, pre-pubertal status (Tanner Stage I), and recent bariatric surgery.

Why it matters

Who can join: the full rules

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).

Where it's running

• The Children's Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Xiaoyan li
• Email: xiaoyan.li@innoventbio.com
• Phone: 18756032014

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.