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

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

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

Sponsors & Collaborators

• Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

  lead OTHER

Principal Investigators

• Weiping Jia, M.D,Ph. D · Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-31

Primary Completion

2026-08-31

Completion

2026-12-31

Countries

• China

Study Locations