Lilly's next-gen weight loss drug more than doubled Novo Nordisk's in trial

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Retatrutide lowered A1C, a blood sugar measure, by 2.2% versus 1.8% for Ozempic, but 7.9% on the 12 mg dose stopped treatment over side effects

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Eli Lilly $LLY reported results on Wednesday from a head-to-head trial in which its experimental drug retatrutide led to over twice as much weight loss as Novo Nordisk's Ozempic in adults with type 2 diabetes.

Participants taking 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 after 80 weeks, the company said. Those taking Ozempic at 2 mg, its highest approved dose, lost an average of 20.9 pounds (9.4%).

Ozempic cut A1C, a gauge of blood sugar levels over time, by 1.8%, while both retatrutide doses brought it down 2.2% on average. Lilly said retatrutide delivered greater improvements than Ozempic in non-HDL cholesterol, triglycerides and systolic blood pressure.

Lilly said the 12 mg dose met the trial's primary objective of showing it was noninferior to Ozempic on A1C reduction. For the 9 mg dose, the A1C advantage over Ozempic reached nominal statistical significance.

Side effects led more retatrutide participants to stop treatment. Discontinuation rates due to adverse events were 4.8% on the 9 mg dose and 7.9% on the 12 mg dose, compared with 2.7% on Ozempic, according to Lilly. Diarrhea affected 28.3% and 32.7% of participants on the two retatrutide doses, versus 26.4% on Ozempic. Nausea affected 21.2% and 23.8%, versus 21.3%. Lilly said most of these events were mild to moderate.

The Phase 3 trial, called TRANSCEND-T2D-2, enrolled 1,298 adults whose diabetes was not controlled with metformin, with or without an SGLT2 inhibitor. The open-label study randomized participants 2:2:1 to retatrutide 9 mg, retatrutide 12 mg or Ozempic 2 mg. Lilly said it is the sixth Phase 3 trial in which retatrutide has delivered strong efficacy.

Retatrutide is a once-weekly injection that activates the receptors for the hormones GIP, GLP-1 and glucagon. Lilly said the drug has not been approved by the U.S. Food and Drug Administration or any other regulator. Lilly plans to seek U.S. approval next year, according to Reuters.

Ambre James-Brown, head of Novo's global media, said Ozempic should not be judged on weight loss alone, according to Reuters. She noted that the drug's top doses have also shown positive effects on cardiac, renal and hepatic health.

Lilly said it will share the full findings at an upcoming medical conference and in a peer-reviewed journal publication. Lilly is also comparing retatrutide with Zepbound’s active compound, tirzepatide, in another late-stage study involving adults with obesity, according to Reuters.

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