Survodutide Once Weekly for the Treatment of Adults with Obesity.
The SYNCHRONIZE-1 trial was a phase 3, double-blind, randomized controlled trial evaluating survodutide — an investigational dual glucagon receptor and GLP-1 receptor agonist — for weight management in adults with obesity (BMI ≥30, or ≥27 with an obesity-related complication) who did not have diabetes. A total of 725 participants were randomized 1:1:1 to one of two dose levels of once-weekly subcutaneous survodutide or placebo, alongside lifestyle counseling, over 76 weeks. The study found that both survodutide groups achieved significantly greater mean body weight reductions compared to placebo (-12.2% and -13.0% versus -5.4%). Approximately 72% of participants in each survodutide group achieved at least 5% body weight reduction, compared to about 46% in the placebo group. The primary analysis used a treatment-regimen estimand accounting for early discontinuations and protocol deviations. Limitations include the relatively short 76-week duration for a chronic condition, the exclusion of people with diabetes, and industry funding by Boehringer Ingelheim. Long-term cardiovascular and safety outcomes remain to be established in ongoing or future trials.