Eli Lilly to seek FDA approval for retatrutide in early 2027 after Phase 3 trials show over 20% weight loss

Eli Lilly said its next‑generation obesity drug retatrutide produced substantial weight loss in two late‑stage Phase 3 studies. The data were presented from the TRIUMPH‑2 and TRIUMPH‑3 trials, which enrolled patients with obesity, type 2 diabetes or severe obesity with cardiovascular disease.

In the TRIUMPH‑2 trial, a 12‑mg weekly injection led to a 20.8% reduction in body weight after 80 weeks, compared with a 4% drop in the placebo group. The drug also improved glycemic control, reinforcing its potential as a best‑in‑class therapy.

Based on these results, Lilly now plans to file an FDA marketing application in the first quarter of 2027, pushing the timeline back from an earlier expectation of filing later this year.

Analysts at BMO Capital Markets highlighted the positive readouts, noting they strengthen retatrutide’s efficacy profile and overall benefit‑risk assessment.