Clinical trial
A Study of IBI362 in Chinese Adolescents With Obesity or Overweight
Recruiting now · Phase 3 · 1 countries · Registry ID NCT07255209
Recruiting nowPhase 3Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age12 Years to 18 Years
SexAll
Healthy volunteersNot accepted
ConditionAdolescents With Obesity or Overweight With Weight-Related Comorbidities
Full registry criteria
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).
Treatments and study arms
Placebo
Drug
Placebo SA.QW
IBI362
Drug
IBI362 SA.QW
Primary outcomes
Percent Change from Baseline in BMIWeek 32
Study locations
1 locations were listed when this page was built. The first 40 are shown.
The Children's Hospital, Zhejiang University School of Medicine🇨🇳 Hangzhou, Zhejiang, China
Junfen FuContact
Junfen Fu, M.DPrincipal Investigator