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
Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
200 participants
Aug 25, 2025
INTERVENTIONAL
Conditions
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
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Efsubaglutide Alfa 20 mg QW
Efsubaglutide Alfa 40 mg QW
Efsubaglutide Alfa 40 mg Q2W
Efsubaglutide Alfa 80 mg QW
Efsubaglutide Alfa 80 mg Q4W
Placebo
Locations(5)
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NCT07114419