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

Phase 1 Completed 36 enrolled Innovent Biologics (Suzhou) Co. Ltd.

RandomizedSequentialDouble-blindTreatment

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.

Timeline

Start: 2024-08-30
Primary completion: 2025-07-22
Completion: 2025-08-01

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mazdutide	Protein / enzyme biologic	4 mg	Subcutaneous
Subject	Mazdutide	Protein / enzyme biologic	6 mg	Subcutaneous

Indications

No indication recorded.