NCT06921486

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

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIb/III Clinical Trial to Evaluate the Efficacy and Safety of Efsubaglutide Alfa Injection in Overweight and Obese Subjects

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,003 (actual)
• Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity and Overweight

Interventions

Type	Name	Description
DRUG	Phase IIb：Efsubaglutide Alfa 5 mg QW	IIb：Efsubaglutide Alfa 5 mg QW
DRUG	Phase IIb：Efsubaglutide Alfa 10 mg QW	Efsubaglutide Alfa 10 mg QW
DRUG	Phase IIb：Efsubaglutide Alfa 20 mg QW	Efsubaglutide Alfa 20 mg QW
DRUG	Phase IIb：Efsubaglutide Alfa 20 mg Q2W	Efsubaglutide Alfa 20 mg Q2W
DRUG	Phase IIb：Placebo	Placebo
DRUG	Phase III：Recommended Phase 3 Dose High Dose	The Recommended Phase 3 Dose High Dose confirmed by the IDMC (Independent Data Monitoring Committee) based on the safety and efficacy data results from the 18-week Phase IIb.
DRUG	Phase III：Recommended Phase 3 Dose Low Dose	The Recommended Phase 3 Dose Low Dose confirmed by the IDMC (Independent Data Monitoring Committee) based on the safety and efficacy data results from the 18-week Phase IIb.
DRUG	Phase III：Placebo	Placebo

Timeline

• Start date: 2025-03-31
• Primary completion: 2026-08-31
• Completion: 2026-12-31
• First posted: 2025-04-10
• Last updated: 2026-01-30

Locations

41 sites across 1 country: China