drugset / Trial / NCT07114419

The Efficacy and Safety of Efsubaglutide Alfa in Overweight/Obesity(SPARKLE)

NCT07114419

Phase 2 Recruiting 200 enrolled Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multicenter, double-blind, randomized, placebo-controlled phase Ⅱ study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of YN-011 in subjects with overweight (27 kg/m2 ≤ BMI \< 30 kg/m2, with at least one comorbidity) or obesity (BMI ≥ 30 kg/m2, with or without comorbidities). The entire study period will consist of a 2-week screening period, a 22-week double-blind treatment period, and a 4-week off-treatment follow-up period

Timeline

Start
2025-08-25
Primary completion
2026-06-01
Completion
2026-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Efsubaglutide Alfa Protein / enzyme biologic 20 mg
Subject Efsubaglutide Alfa Protein / enzyme biologic 40 mg
Subject Efsubaglutide Alfa Protein / enzyme biologic 80 mg

Indications