NCT07114419

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

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Efsubaglutide Alfa Injection in Subjects With Overweight or Obesity

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Obesity and Overweight

Interventions

Type	Name	Description
DRUG	Efsubaglutide Alfa 20 mg QW	Efsubaglutide Alfa 20 mg QW
DRUG	Efsubaglutide Alfa 40 mg QW	Efsubaglutide Alfa 40 mg QW
DRUG	Efsubaglutide Alfa 40 mg Q2W	Efsubaglutide Alfa 40 mg Q2W
DRUG	Efsubaglutide Alfa 80 mg QW	Efsubaglutide Alfa 80 mg QW
DRUG	Efsubaglutide Alfa 80 mg Q4W	Efsubaglutide Alfa 80 mg Q4W
OTHER	Placebo	Placebo

Timeline

• Start date: 2025-08-25
• Primary completion: 2026-06-01
• Completion: 2026-08-01
• First posted: 2025-08-11
• Last updated: 2025-12-02

Locations

5 sites across 1 country: Australia