Study summary · research use only
Survodutide for treatment of obesity: rationale and design of two randomized phase 3 clinical trials (SYNCHRONIZE™-1 and -2)
Plain-language summary
Paraphrased from the published abstract below — not a verdict on whether anything works.
This article describes the rationale and design of two phase 3, double-blind, randomized clinical trials of survodutide, an investigational dual glucagon and GLP-1 receptor agonist, for treatment of obesity with or without type 2 diabetes (T2D) in adult human patients. Participants receive once-weekly subcutaneous survodutide, uptitrated to 3.6 or 6.0 mg with dose flexibility, or placebo added to lifestyle modification. SYNCHRONIZE-1 (n = 726) enrolls participants with BMI ≥ 30 kg/m2, or ≥ 27 kg/m2 with an obesity-related complication, without T2D; SYNCHRONIZE-2 (n = 755) enrolls participants with BMI ≥ 27 kg/m2 and T2D. Primary endpoints are percentage weight change and proportion achieving ≥5% weight reduction by week 76.
Abstract
The objective of this study was to describe the rationale and design of two multinational phase 3 clinical trials of survodutide, an investigational glucagon and glucagon-like peptide-1 receptor dual agonist for the treatment of obesity with or without type 2 diabetes (T2D; SYNCHRONIZE-1 and -2). In these ongoing double-blind trials, participants were randomized to once-weekly subcutaneous injections of survodutide or placebo added to lifestyle modification. Survodutide doses are uptitrated to 3.6 or 6.0 mg, and dose flexibility is permitted. Participants (n = 726) in SYNCHRONIZE-1 (NCT06066515) have a baseline BMI ≥ 30 kg/m2 or ≥27 kg/m2 with at least one obesity-related complication but without T2D; participants (n = 755) in SYNCHRONIZE-2 (NCT06066528) have a baseline BMI ≥ 27 kg/m2 and T2D. The primary endpoints are percentage change in body weight and proportion of participants achieving ≥5% body weight reduction from baseline to week 76. Secondary endpoints include change in systolic blood pressure and measures of glycemia. A SYNCHRONIZE-1 substudy is evaluating changes in body composition and liver fat content using magnetic resonance imaging. These trials are designed to provide robust evaluation of the efficacy, safety, and tolerability of survodutide for the treatment of obesity in the presence or absence of T2D.
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