Eli Lilly and CompanyPositive Phase 3 results for retatrutide and planned FDA submission next year

US pharmaceutical giant Eli Lilly announced positive results from two Phase 3 clinical trials for its obesity treatment candidate retatrutide, and revealed plans to submit an application to the US Food and Drug Administration in the first quarter of next year. In an 80-week trial involving adults with severe obesity and heart disease, the highest dose group showed an average weight reduction of 22.6 percent. In another 80-week trial involving overweight or obese patients with type 2 diabetes, the highest dose group saw weight decrease by 20.8 percent and HbA1c levels drop by 1.6 percent. The overall frequency of cardiovascular events was low, but when limited to three serious events—heart attack, stroke, and death—the risk in the retatrutide group was 12 percent higher than in the placebo group. Analysts say this imbalance is difficult to interpret, but note that the improving trend in patients who continued treatment is promising.
Eli Lilly and CompanyPositive Phase 3 results for retatrutide and planned FDA submission next year