SHIFT Newsroom · GLOBAL
Survodutide met a heart-safety benchmark in a phase 3 trial
The trial met its prespecified safety threshold. It did not show that survodutide prevents cardiovascular events.
In the 9 November Lancet report, 5,530 adults with overweight or obesity and elevated health risks were randomly assigned to weekly survodutide injections or placebo. Of 5,507 who started treatment, 136 of 3,671 (3.7%) in the combined survodutide groups and 76 of 1,836 (4.1%) on placebo had a major cardiovascular event, including events such as heart attack, stroke or heart failure. Median follow-up was 22 months. The hazard ratio was 0.89 (95% confidence interval 0.67–1.18), meeting the trial’s safety threshold of 1.65.
Safety: Digestive side effects led 19.3% and 20.8% of the two survodutide groups to stop study treatment, versus 1.9% on placebo.
SHIFT’s take: The trial answered a safety question in a higher-risk group. Survodutide remains investigational; this result does not establish UK availability.
Source links: Original Lancet study, online 9 November02140-9) · AHA conference summary · Trial registry.
SHIFT’s take
A separate SHIFT interpretation has not been added to this report.
Known facts
- The trial met its prespecified safety threshold. It did not show that survodutide prevents cardiovascular events.