A Randomized, Double-blind, Placebo-controlled Phase Ib Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of Efsubaglutide Alfa in Chinese Adolescents With Obesity
This is a Phase Ib, randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Efsubaglutide Alfa Injection following multiple-dose administration in Chinese adolescent participants with obesity.
• 1\. Informed consent must be obtained from the participant's parent or legally authorized representative and assent from the adolescent participant before any study-related procedures.
• 2\. Adolescent participants aged ≥12 years and \<18 years (at the time of informed consent).
• 3\. At screening, meet the obesity criteria defined in WS/T586-2018 Screening for Overweight and Obesity among School-age Children and Adolescents.
• 4\. Before screening, have been on dietary and exercise control alone for at least 3 months with \<5.0% reduction in body mass index (based on self-report or report by parent or legally authorized representative).
• 5.Must be willing to follow the diet and exercise guidance and able to maintain such stable diet and exercise lifestyle during the study period.
• 6\. Female participants of childbearing potential must have a negative serum pregnancy test at screening.
• 7\. Able to understand all study procedures, willing to strictly comply with the study protocol, complete the study visits as scheduled, and finish the study.