Eli Lilly and Company (NYSE: LLY) said its investigational drug retatrutide delivered “more than double the weight loss of the highest approved dose of Ozempic,” from Novo Nordisk A/S (NYSE: NVO), in a head-to-head Phase 3 trial in adults with type 2 diabetes.
Lilly announced topline results from the TRANSCEND-T2D-2 trial on Wednesday. Lilly describes retatrutide as a once-weekly drug that activates three hormone receptors in one molecule: GIP, GLP-1 and glucagon. The trial compared it with Ozempic 2 mg. The 80-week, open-label study enrolled 1,298 adults with type 2 diabetes whose blood sugar was not well controlled on metformin, with or without an SGLT2 inhibitor.
TRANSCEND-T2D-2 Results
Lilly said retatrutide met the trial’s main goal and all of its key secondary goals at 80 weeks. Participants’ A1C, a measure of blood sugar control, dropped an average of 2.2% on both retatrutide doses, versus 1.8 on Ozempic, from an average starting level of 8.3%. Participants weighed an average of 225.8 pounds at the start. Those on retatrutide lost an average of 44.3 pounds (19.5%) on the 9 mg dose and 47.4 pounds (20.9%) on the 12 mg dose, versus 20.9 pounds (9.4%) on Ozempic.
“Based on these results and those from across our Phase 3 program, we believe retatrutide, if approved, could shift the treatment paradigm for people living with type 2 diabetes, obesity and related cardiometabolic conditions,” said Kenneth Custer, executive vice president and president of Lilly Cardiometabolic Health.
Side Effects, Safety And Availability
Diarrhea was among the most common side effects, affecting 28.3% of participants on retatrutide 9 mg and 32.7% on 12 mg, versus 26.4% on Ozempic. The share who stopped treatment because of side effects was 4.8% on 9 mg and 7.9% on 12 mg, versus 2.7% on Ozempic. Lilly said most side effects were mild-to-moderate and typically resolved during treatment.
Retatrutide has not been approved by the U.S. Food and Drug Administration or any regulatory organization anywhere, the company noted.
Retatrutide’s TRIUMPH Trial Results
In July, Lilly said the TRIUMPH-2 trial of retatrutide in adults with type 2 diabetes and obesity or excess weight met its main goal, with 12 mg participants losing an average 49.6 pounds over 80 weeks. Lilly had said then that it was targeting a U.S. regulatory submission for retatrutide in the first quarter of 2027.
Price Action: Eli Lilly shares were down 0.82% to $1,271.45, while Novo Nordisk shares were down 1.27% to $38.18 during premarket trading on Wednesday.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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