A Study of IBI362 in Chinese Adolescents With Obesity or Overweight
Recruiting · NCT07255209 · Interventional (participants receive a specific treatment) · Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
IBI362Placebo
What this trial 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.
Who can take part
Age range
12 Years to 18 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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).
Exclusion criteria
- 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
1 location listed.
- The Children's Hospital, Zhejiang University School of Medicine - Hangzhou, Zhejiang, China