Archive photo: Lilly Corporate Center, Indianapolis. Momoneymoproblemz, CC BY-SA 4.0 (cropped)
Eli Lilly said Wednesday that its experimental drug retatrutide reduced blood sugar and body weight more than Ozempic’s highest approved diabetes dose in a Phase 3 trial, offering new head-to-head data on a treatment that remains unapproved.
In its announcement of topline results, Lilly said both retatrutide doses lowered A1C, a measure of average blood sugar, by 2.2 percentage points at 80 weeks. The reduction was 1.8 percentage points with Ozempic 2 mg. Participants began with an average A1C of 8.3%.
Average body-weight reductions were 19.5%, or 44.3 pounds, with retatrutide 9 mg and 20.9%, or 47.4 pounds, with 12 mg. The Ozempic group lost an average of 9.4%, or 20.9 pounds, according to the company.
Results are preliminary company-reported data
The TRANSCEND-T2D-2 trial randomized 1,298 adults with type 2 diabetes inadequately controlled with metformin, with or without an SGLT2 inhibitor. It was open-label, meaning treatment assignments were not blinded. Participants received once-weekly retatrutide 9 mg, retatrutide 12 mg or Ozempic 2 mg.
Lilly said the study met its primary and all key secondary endpoints. The primary objective was to show that retatrutide 12 mg was not inferior to Ozempic 2 mg in A1C reduction at 80 weeks. Lilly reported statistically significant superiority for the 12 mg dose’s A1C reduction and for weight loss at both retatrutide doses. The 9 mg dose’s A1C superiority was a prespecified secondary result with nominal statistical significance rather than a comparison controlled for multiple testing.
The figures in the announcement use an efficacy estimand: an analysis estimating what would happen if all randomized participants remained on treatment for 80 weeks without starting additional blood-sugar medication for more than 14 days. They should not be read as results for every patient regardless of treatment changes or discontinuation.
Lilly said detailed results will be presented at a future medical meeting and published in a peer-reviewed journal. These are the sponsor’s topline findings, not an independent assessment of the complete trial data.
Side effects and approval status matter
Gastrointestinal side effects were common. Diarrhea occurred in 28.3% and 32.7% of the retatrutide 9 mg and 12 mg groups, respectively, versus 26.4% with Ozempic. Nausea occurred in 21.2% and 23.8%, versus 21.3%. Lilly said most reported events were mild to moderate and typically resolved during treatment.
Treatment discontinuations because of adverse events were 4.8% with retatrutide 9 mg and 7.9% with 12 mg, compared with 2.7% with Ozempic. Altered skin sensations, described as dysesthesia, occurred in 4.8% and 6.5% of retatrutide participants, versus 2.7% with Ozempic.
Retatrutide is a once-weekly investigational medicine that acts on GIP, GLP-1 and glucagon receptors. Lilly said it has not been approved by the FDA or any other regulator anywhere in the world and cannot legally be sold or marketed for human use. The trial announcement does not change that status.
JBizNews Desk | Indianapolis
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