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A Study of IBI362 in Chinese Adolescents With Obesity or Overweight

RecruitingPhase 3Ages 12 Years - 18 YearsAllInnovent Biologics (Suzhou) Co. Ltd.
NCT07255209 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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).
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What it tests

  • Placebo
  • IBI362
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Where

1 site
The Children's Hospital, Zhejiang University School of Medicine
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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