Key insights
- Eli Lilly's investigational drug retatrutide demonstrated superior efficacy compared to Ozempic in a Phase 3 trial for type 2 diabetes. Retatrutide achieved greater reductions in A1C and body weight, as well as improvements in non-HDL cholesterol, triglycerides, and systolic blood pressure. While adverse events were noted, the results position retatrutide as a potentially significant advancement in diabetes and obesity treatment, pending regulatory approval.
Eli Lilly and Company (LLY) reported that its investigational drug retatrutide reduced blood sugar and body weight more than Ozempic 2 mg in a Phase 3 head-to-head clinical trial involving adults with type 2 diabetes.
The TRANSCEND-T2D-2 trial, which enrolled 1,298 participants over 80 weeks, showed that both doses of retatrutide (9 mg and 12 mg) reduced A1C by an average of 2.2 percentage points, compared with 1.8 percentage points for Ozempic 2 mg. Participants started with an average baseline A1C of 8.3%.
On body weight, participants taking retatrutide 9 mg lost an average of 44.3 lbs (19.5%), and those on 12 mg lost 47.4 lbs (20.9%), compared with 20.9 lbs (9.4%) for Ozempic. Average baseline body weight across participants was approximately 225.8 lbs.
Retatrutide also showed greater reductions than Ozempic in non-HDL cholesterol, triglycerides, and systolic blood pressure.
The most common adverse events with retatrutide included diarrhea, nausea, constipation, vomiting, and dyspepsia. Treatment discontinuation rates due to adverse events were 4.8% for the 9 mg dose and 7.9% for the 12 mg dose, compared with 2.7% for Ozempic. The incidence of dysesthesia was higher with retatrutide (4.8% and 6.5%) than with Ozempic (2.7%).
Retatrutide is a once-weekly injectable triple hormone receptor agonist that activates receptors for GIP, GLP-1, and glucagon. It has not been approved by the FDA or any other regulatory body and cannot be legally sold or marketed.
Lilly said detailed results will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal. The company is also conducting TRIUMPH-5, an ongoing Phase 3 trial comparing retatrutide head-to-head with tirzepatide in adults with obesity.
According to a press release from Lilly, TRANSCEND-T2D-2 is the sixth Phase 3 trial in which retatrutide has been evaluated.
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