Lilly reports positive results for experimental drug in trial involving 1,298 people with diabetes

Key Facts

On October 28, 2026, Lilly announced positive topline results from the Phase 3 TRANSCEND-T2D-2 trial, which directly compared its experimental drug retatrutide with Ozempic in adults with type 2 diabetes. The study included 1,298 participants whose diabetes was not adequately controlled with metformin, with or without an SGLT2 inhibitor. The trial was randomized and open-label, according to the company’s statement. Lilly said retatrutide achieved greater improvements than Ozempic in some cardiovascular risk factors. These measures included non-HDL cholesterol, triglycerides and systolic blood pressure.

The head-to-head comparison is important in assessing how a potential drug performs against treatments currently available. Kenneth Custer, a Lilly executive, said, "Head-to-head trials show patients and physicians how a potential drug compares with the treatments available and covered by insurance today." He added that retatrutide’s potential therapeutic impact remains conditional on approval. The drug is still experimental, is administered once weekly and activates GIP, GLP-1 and glucagon receptors. The company said it has not been approved by the Food and Drug Administration or any regulatory authority worldwide.

Tolerability data showed differences among the groups in discontinuation due to side effects. The rate was 4.8% with the 9 mg dose of retatrutide and 7.9% with the 12 mg dose, compared with 2.7% with Ozempic. Diarrhea was a common side effect in the trial. Lilly reported rates of 28.3% with the 9 mg dose, 32.7% with the 12 mg dose and 26.4% with Ozempic. The company said most cases were mild to moderate and typically resolved during treatment.

Lilly plans to submit a biologics license application for retatrutide to the Food and Drug Administration in the first quarter of 2027. The study also includes an extension period in which about 650 participants will continue treatment for an additional 24 weeks. The period is intended to assess long-term efficacy and safety, according to the company. Detailed trial results are due to be presented at a future medical meeting and published in a peer-reviewed journal, with no date specified for either. Lilly shares closed at $1,281.91 on October 27, 2026, according to EL7 data.