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Survodutide for treatment of obesity: rationale and design of two randomized phase 3 clinical trials (SYNCHRONIZE™‐1 and ‐2)
Survodutide as a treatment for obesity: reasons and plan for two large clinical trials
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Abstract
A total of 1,481 participants will be evaluated in two multinational phase 3 clinical trials of survodutide for treatment.
- SYNCHRONIZE-1 includes participants with a BMI ≥ 30 kg/m or ≥ 27 kg/m with at least one obesity-related complication but without type 2 diabetes.
- SYNCHRONIZE-2 includes participants with a BMI ≥ 27 kg/m and type 2 diabetes.
- Primary endpoints focus on the percentage change in body weight and the proportion of participants achieving a ≥5% body weight reduction from baseline to week 76.
- Secondary endpoints assess changes in systolic blood pressure and measures of glycemia.
- A substudy in SYNCHRONIZE-1 will evaluate changes in body composition and liver fat content using magnetic resonance imaging.
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Key numbers
726
Participants in SYNCHRONIZE-1
Total number of participants randomized in SYNCHRONIZE-1.
755
Participants in SYNCHRONIZE-2
Total number of participants randomized in SYNCHRONIZE-2.
76 weeks
Duration of trials
Length of treatment period for both trials.