Outcomes summary

Phase 3, 68-week randomized, double-blind trial in 3,417 adults with obesity or overweight without type 2 diabetes; CagriSema (cagrilintide 2.4 mg + semaglutide 2.4 mg) achieved statistically significant and superior weight loss versus placebo; under trial product estimand, mean weight loss was 22.7% with CagriSema versus 2.3% with placebo, with 40.4% of patients achieving >=25% weight loss.

Limitations

Flexible protocol allowed dose modifications throughout the trial; only 57.3% of CagriSema patients reached the highest dose; trial duration and population may limit generalizability; long-term safety and hard outcomes require additional evidence; results depend on dose-escalation and adherence.

Notes

Primary source: New England Journal of Medicine, REDEFINE 1 (2024).