Adolescents With Obesity or Overweight With Weight-Related Comorbidities
Conditions
Brief summary
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.
Interventions
DRUGPlacebo
Placebo SA.QW
DRUGIBI362
IBI362 SA.QW
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in BMI | Week 32 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants with ≥5% BMI Reduction | Week 32 |
| Percent Change from Baseline in BMI | Week 52 |
Countries
China
Contacts
Primary ContactXiaoyan li
Outcome results
None listed