Update, November 2, 2026. Two things have happened since this item ran. On August 3, Lilly confirmed a small early-access program that physicians can request for patients who cannot join a trial. On October 28, it reported topline results from TRANSCEND-T2D-2, a head-to-head trial in adults with type 2 diabetes: 19.5% and 20.9% weight loss on 9 and 12 mg at 80 weeks, against 9.4% on semaglutide 2 mg, using the efficacy estimand. Those figures are not peer reviewed. Retatrutide is still not approved.
Eli Lilly announced on July 23, 2026 that retatrutide met its main goal in two more phase 3 trials, and said it plans to submit the drug to the FDA in the first quarter of 2027.
What changed. In TRIUMPH-2, adults with obesity or overweight and type 2 diabetes lost an average of 12.7%, 19.1% and 20.8% of body weight on 4, 9 and 12 mg over 80 weeks, versus 4.0% on placebo. In TRIUMPH-3, adults with a BMI of 35 or more and established heart disease lost 21.6% and 22.6% on 9 and 12 mg, versus 3.2%. These are Lilly’s topline figures using the efficacy estimand, which estimates the effect had everyone stayed on treatment. Lilly said it now has the clinical data to support submissions and is finishing its manufacturing documentation first.
What it means. Retatrutide now has several positive phase 3 trials and a stated filing date. Side effects were a real cost: stopping because of them reached 11.6% on 9 mg in TRIUMPH-2 and 13.5% on 12 mg in TRIUMPH-3, against under 5% on placebo.
If you take this or are considering it. If you have type 2 diabetes or heart disease, these trials looked at people closer to you than the earlier obesity trials did, and the weight results are large. They still cannot tell you how you would do. They are topline figures that assume everyone stayed on treatment, and more than 1 in 10 people stopped because of side effects at some doses. If you are on tirzepatide or semaglutide now, a planned filing changes nothing today, since a filing is only the start of FDA review. Anything offered online as retatrutide is an unverified product; Lilly’s own position is quoted below.
What has not changed. Retatrutide is not approved and has not yet been submitted. Lilly says it “cannot be legally sold or marketed for human use.” The retatrutide guide has the full trial picture.