Survodutide for Obesity Management
The SYNCHRONIZE-1 and SYNCHRONIZE-2 trials are 76-week, multinational, randomized, double-blind, placebo-controlled phase 3 studies evaluating once-weekly subcutaneous survodutide as an adjunct to reduced-calorie diet and increased physical activity for chronic weight management. SYNCHRONIZE-1 is enrolling adults with obesity or overweight plus weight-related comorbidities but without type 2 diabetes. SYNCHRONIZE-2 is enrolling adults with obesity or overweight and type 2 diabetes. Participants are randomized to survodutide 3.6 mg, survodutide 6.0 mg, or placebo. The primary endpoints are percent change in body weight and the proportion of participants achieving at least 5% body weight reduction at week 76, with key secondary endpoints including greater weight-loss thresholds, waist circumference, systolic blood pressure, eating behavior measures, and HbA1c in the type 2 diabetes trial.
The trials are designed to clarify the efficacy, safety, and tolerability of survodutide, a dual glucagon/GLP-1 receptor agonist that may affect body weight through reduced energy intake, potential effects on energy expenditure, and liver-related metabolic effects. SYNCHRONIZE-1 includes an MRI substudy assessing body composition and liver fat. Both studies use a slower, flexible dose-escalation strategy intended to reduce gastrointestinal adverse events that commonly limit GLP-1-based therapies. The authors note that the studies will provide important data on survodutide’s role in obesity treatment, including in patients with type 2 diabetes, but they also acknowledge limitations: the trials mainly assess weight-related outcomes through 76 weeks and exclude some patients with uncontrolled hypertension, recent cardiovascular events, or significant mood disorders, which may limit generalizability.
Reference: Wharton S, le Roux CW, Kadowaki T, et al. Survodutide for treatment of obesity: rationale and design of two randomized phase 3 clinical trials SYNCHRONIZE-1 and -2. Obesity (Silver Spring). 2025 Jan;33(1):67-77. doi: 10.1002/oby.24184.
HoChong Gilles
DNP, FNP-BC