Eli Lilly said Wednesday its investigational retatrutide produced greater average weight loss than Ozempic 2 mg in an 80-week Phase 3 study of adults with type 2 diabetes.
The retatrutide 12 mg group lost an average of 20.9% of body weight, or 21.5 kilograms, by week 80. Those assigned 9 mg lost 19.5%, or 20.1 kg; the Ozempic group lost 9.4%, or 9.5 kg. Lilly said the weight figures came from its efficacy-estimand analysis.
Both retatrutide doses lowered average A1C by 2.2 percentage points, compared with a 1.8-point reduction for Ozempic. Participants began the study with average A1C of 8.3%. Lilly said the main trial test compared the A1C reduction from retatrutide 12 mg with Ozempic’s; the study met its noninferiority objective.
TRANSCEND-T2D-2 enrolled 1,298 adults whose type 2 diabetes was not adequately controlled with metformin, alone or alongside an SGLT2 inhibitor. Participants were assigned to once-weekly retatrutide at 9 mg or 12 mg, or weekly Ozempic 2 mg. Their average starting weight was 102.4 kg, and mean BMI was 36.8 kg/m². Lilly said the study was open-label.
Lilly reported that discontinuations due to adverse events occurred in 4.8% of participants on retatrutide 9 mg and 7.9% on 12 mg, compared with 2.7% on Ozempic. Diarrhea, nausea and constipation were among the most commonly reported events with retatrutide. The company also reported greater improvements with retatrutide in non-HDL cholesterol, triglycerides and systolic blood pressure, but did not provide effect sizes in its announcement.
Lilly said its efficacy estimand estimates outcomes had all randomized participants remained on treatment for 80 weeks, subject to the study’s stated conditions. STAT described the results as covering participants who continued treatment; the full methods have not been published.
Retatrutide is an investigational medicine that targets GIP, GLP-1 and glucagon receptors. Lilly says it has not been approved for public use. Lilly said it plans to present the complete findings at a future medical meeting and publish them in a peer-reviewed journal, but announced no dates.
