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
Sex
ALL
Min age
12 Years
Max age
18 Years
Healthy volunteers
No
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).
Primary outcome measure(s)
Percent Change from Baseline in BMI — Week 32
Trial sites (1)
Facility
City
Region
Status
The Children's Hospital, Zhejiang University School of Medicine
Hangzhou
Zhejiang
Recruiting
More Innovent Biologics (Suzhou) Co. Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.