drugset / Trial / NCT06921486

The Efficacy and Safety of Efsubaglutide Alfa Injection in Overweight and Obese Subjects (ENLIGHT)

NCT06921486

Phase 2/3 Active not recruiting 1003 enrolled Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a multicenter, randomized, double-blind, placebo-controlled Phase IIb/III clinical trial aimed at evaluating the efficacy, safety, pharmacokinetics (PK), and immunogenicity profile of Efsubaglutide Alfa injection in overweight and obese subjects. The primary endpoint of the Phase IIb is the percentage change in body weight from baseline after 18 weeks of treatment. The primary endpoint of the Phase III is the percentage change in body weight from baseline after 30 weeks of treatment, the secondary endpoint is the percentage change in body weight from baseline after a cumulative 48 weeks of treatment.

Timeline

Start
2025-03-31
Primary completion
2026-08-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Efsubaglutide Alfa Protein / enzyme biologic 5 mg
Subject Efsubaglutide Alfa Protein / enzyme biologic 10 mg
Subject Efsubaglutide Alfa Protein / enzyme biologic 20 mg

Indications