drugset / Trial / NCT07114419
The Efficacy and Safety of Efsubaglutide Alfa in Overweight/Obesity(SPARKLE)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Efsubaglutide Alfa | Protein / enzyme biologic | 20 mg | — |
| Subject | Efsubaglutide Alfa | Protein / enzyme biologic | 40 mg | — |
| Subject | Efsubaglutide Alfa | Protein / enzyme biologic | 80 mg | — |