Study
Survodutide Once Weekly for the Treatment of Adults with Obesity (SYNCHRONIZE-1)
Phase 3 (N=725) survodutide 3.6/6.0 mg weekly cut body weight ~12-13% vs 5.4% placebo at 76 weeks; ~72% achieved >=5% loss; GI AEs 81-90% but no deaths.
The SYNCHRONIZE-1 trial randomized 725 adults with obesity without diabetes 1:1:1 to weekly subcutaneous survodutide 3.6 mg, 6.0 mg, or placebo for 76 weeks. Survodutide is a dual GLP-1/glucagon receptor agonist from Boehringer Ingelheim, licensed from Zealand Pharma. Mean body-weight change (treatment-regimen estimand) was -12.2% (95% CI -13.6 to -10.8) at 3.6 mg, -13.0% (95% CI -14.4 to -11.6) at 6.0 mg, and -5.4% (95% CI -6.9 to -4.0) with placebo. 72.6% and 71.9% of the two survodutide groups achieved at least 5% weight reduction versus 46.3% with placebo (P<0.001 for both survodutide comparisons). Gastrointestinal adverse events occurred in 80.9% (3.6 mg), 89.7% (6.0 mg), and 47.9% (placebo), typically mild to moderate. No deaths were reported. This is the pivotal Phase 3 efficacy trial supporting Boehringer's regulatory submissions.
Survodutide led to significantly greater reductions in body weight than placebo in adults with obesity without diabetes.
Efficacy is competitive with tirzepatide and semaglutide but not clearly superior on head-to-head weight-loss magnitude. Nearly 90% GI AE rate at the 6.0 mg dose is a real tolerability concern, and press coverage of prior readouts noted ~19% discontinuation from side effects, roughly three times the tirzepatide rate. No cardiovascular outcomes data yet; SYNCHRONIZE-CVOT is ongoing.
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