NCT06536023

This is a Study to Evaluate the Pharmacokinetics and Safety of IBI362 in Chinese Adolescents With Obesity

A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability and Pharmacokinetics of IBI362 in Chinese Obese Adolescent Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a first-in-pediatric assessment of the safety, tolerability, and pharmacokinetic characteristics of multiple doses of IBI362 in Chinese adolescent subjects with obesity. It employs a multicenter, randomized, double-blind, and placebo-controlled trial design. The study plans to enroll 36 adolescents (aged ≥12 years and \<18 years) with obesity who have experienced less than a 5% decrease in Body Mass Index (BMI) after at least 12 weeks of diet and exercise control.

Conditions

• Adolescents With Obesity

Interventions

Type	Name	Description
DRUG	IBI362	IBI362 SA.QW
DRUG	IBI362 placebo	IBI362 placebo SA.QW

Timeline

• Start date: 2024-08-30
• Primary completion: 2025-07-22
• Completion: 2025-08-01
• First posted: 2024-08-02
• Last updated: 2025-09-12

Locations

1 site across 1 country: China