NCT07114419 The Efficacy and Safety of Efsubaglutide Alfa in Overweight/Obesity（SPARKLE）

Trial Parameters

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Brief 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 Criteria

Inclusion Criteria: 1. Willing to comply with protocol required visit schedule and visit requirements and provide written informed consent form (ICF); 2. Male or female subjects, aged 18 to 75 years (both inclusive) at the time of signing the ICF; 3. Obese: BMI ≥ 30.0 kg/m2, with or without comorbidities; Or overweight: 27.0 kg/m2 ≤ BMI \< 30.0 kg/m2, with at least one of the following weight-related comorbidities: pre-diabetes, hypertension, dyslipidemia, fatty liver, osteoarthritis, or obesity-induced obstructive sleep apnea syndrome (If the subject has only fatty liver as a comorbidity, imaging results within the 3 months prior to screening are required for fatty liver); 4. A self-reported change in body weight less than 5.0% controlled with diet and exercise within 3 months before screening; 5. Women of childbearing potential (WOCBP) and fertile males with WOCBP partners must use highly effective contraception methods throughout the study (from the signing of ICF to 3 months after

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