Eli Lilly’s triple-G drug candidate retatrutide has beaten Novo’s Ozempic in a head-to-head phase 3 trial, driving deeper reductions in blood sugar and body weight across the 80-week study.
The open-label clinical trial compared two doses of retatrutide—9 mg and 12 mg—to Ozempic 2 mg in almost 1,300 adults with Type 2 diabetes. The participants’ diabetes was inadequately controlled with metformin, with or without an SGLT2 inhibitor. At baseline, the patients’ A1C, a measure of blood sugar, averaged 8.3% and ranged from 7.0% to 10.5%.
After 80 weeks of weekly dosing, A1C had fallen 2.2% in both retatrutide cohorts, compared to 1.8% in the Ozempic arm. The difference was statistically significant, achieving the trial’s primary endpoint.
Participants on 9 mg and 12 mg of retatrutide lost 19.5% and 20.9%, respectively, of their body weight. Patients receiving Ozempic lost 9.4% of their body weight. With patients on retatrutide losing twice as much weight, the clinical trial hit its key secondary endpoint.
Lilly has yet to share more data from the trial, but teed up a broad attack on Ozempic. The drugmaker reported greater improvements across certain cardiovascular risk factors, including non-HDL cholesterol, triglycerides and systolic blood pressure, on retatrutide than on Novo's drug.
The available safety and tolerability data suggest the benefits come with downsides for some patients. On the top dose of retatrutide, 7.9% of patients discontinued treatment because of adverse events, compared to 2.7% of people on Ozempic.
Rates of diarrhea, nausea and vomiting were higher on retatrutide, at least at the 12-mg dose, than on Novo's drug. The biggest difference was in diarrhea, which affected up to 32.7% and 26.4% of people on retatrutide and Ozempic, respectively. Other safety and tolerability endpoints favored retatrutide. The rate of constipation on Ozempic was 19.8%, compared to up to 14.2% on retatrutide.
The readout adds to the body of evidence that Lilly is building to support retatrutide, an investigational agonist of GLP-1, GIP and glucagon. In March, the drugmaker posted data from a placebo-controlled trial in Type 2 diabetes. Lilly has also delivered data on retatrutide in obesity patients. The company plans to file for FDA approval of the drug candidate in the first quarter of 2027.
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