Survodutide for treatment of obesity: rationale and design of two randomized phase 3 clinical trials ( SYNCHRONIZE™ ‐1 and ‐2)
Study context
- Population
- Obesity: SYNCHRONIZE-1 BMI ≥ 30 kg/m² or ≥27 kg/m² with ≥1 obesity-related complication, without T2D; SYNCHRONIZE-2 BMI ≥ 27 kg/m² and T2DSYNCHRONIZE-1 726 · SYNCHRONIZE-2 755
- Planned comparison
- Once-weekly SC survodutide vs placebo, added to lifestyle modification
- Primary endpoint
- Percentage change in body weight and proportion achieving ≥5% body weight reduction
- Follow-up
- Baseline to week 76
Methodological detailsSYNCHRONIZE-1 and −2, multinational, double-blind, placebo-controlled, phase 3, ongoing, Secondary endpoints include change in systolic blood pressure and measures of glycemia, SYNCHRONIZE-1 substudy evaluating body composition and liver fat content by MRI
- SYNCHRONIZE-1 and −2
- Multinational
- Double-blind
- Placebo-controlled
- Phase 3
- Ongoing
- Secondary endpoints include change in systolic blood pressure and measures of glycemia
- SYNCHRONIZE-1 substudy evaluating body composition and liver fat content by MRI
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Survodutide for treatment of obesity: rationale and design of two randomized phase 3 clinical trials ( SYNCHRONIZE™ ‐1 and ‐2). Obesity (Silver Spring). Published 4 November 2024. doi:10.
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