Study S000312

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

ClinicalTrials.gov record

Registration

Registration: NCT07693426
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: TRIPLE
Status: RECRUITING
Enrollment: 36
Start: 2026-07-16
Primary completion: 2027-04-30
Lead sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
Conditions: Adolescence Obesity
Interventions: DRUG:Efsubaglutide Alfa 5 mg QW; DRUG:Efsubaglutide Alfa 10 mg QW; DRUG:Efsubaglutide Alfa 20 mg QW; DRUG:Efsubaglutide Alfa placebo
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Safety and tolerability: incidence of TEAEs, SAEs, and AESI [Throughout the study (up to Week 18)]
Pharmacokinetic (PK) characteristics at steady state following multiple doses [Throughout the study (up to Week 18)]

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