SYNCHRONIZE-CVOT

Presented in LBS.05 at AHA 2026 (Monday 9 November) by principal investigator Biykem Bozkurt and published simultaneously in The Lancet; the figures below come from the Boehringer Ingelheim release of 9 November because the paper is not yet readable to us. SYNCHRONIZE-CVOT (NCT06077864) is a phase 3, double-blind, placebo-controlled, event-driven cardiovascular safety trial: 5,530 adults with obesity or overweight and established cardiovascular disease, chronic kidney disease, or at least two weight-related complications or risk factors were randomised to weekly survodutide 3.6 mg, 6.0 mg or placebo. Primary endpoint: time to first 5-point MACE (cardiovascular death, non-fatal MI, non-fatal stroke, ischaemia-related coronary revascularisation or heart failure event), tested for non-inferiority. Result: HR 0.89 (95 percent CI 0.67 to 1.18), non-inferiority met under both the treatment-regimen and the supplementary estimand; 3-point MACE HR 0.84 (0.60 to 1.18). At 72 weeks (supplementary estimand, on treatment): weight minus 13.7 versus minus 2.0 percent, systolic BP minus 6.68 versus minus 1.76 mmHg (P = 0.0001), waist minus 11.96 versus minus 2.74 cm; hs-CRP and triglycerides fell significantly (no figures released). Discontinuation for gastrointestinal adverse events 19.3 percent (3.6 mg), 20.8 percent (6.0 mg) versus 1.9 percent (placebo), mostly during dose escalation. Event counts, median follow-up and the non-inferiority margin are not in the release. André van Beek (UMCG, Groningen) is on the author list. Boehringer says it is preparing regulatory submissions in obesity.