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Eli Lilly's investigational drug retatrutide has delivered more than double the weight loss of Ozempic's highest approved dose in a head-to-head clinical trial, according to new data released Wednesday. The phase 3 TRANSCEND-T2D-2 study compared once-weekly injections of retatrutide (at 9mg and 12mg doses) with Novo Nordisk’s Ozempic (2mg) in over 1,000 adults with type 2 diabetes over an 80-week period.
Participants receiving the highest dose of retatrutide lost an average of 47.4 pounds, while those on the 9mg dose lost 44.3 pounds. In comparison, those on Ozempic lost an average of 20.9 pounds. Retatrutide also led to greater reductions in A1C, a key measure of long-term blood sugar control, lowering it by an average of 2.2%, compared to 1.5% for Ozempic.
In addition to weight loss, the trials reported significant decreases in waist size and improvements in cardiovascular risk factors. Retatrutide also showed benefits in treating obstructive sleep apnea by reducing hypoxic events.
The most common side effects for retatrutide were mild to moderate gastrointestinal issues, which tended to resolve as patients continued treatment. Retatrutide is not yet approved by the U.S. Food and Drug Administration (FDA) or any regulatory agency, and Eli Lilly plans to submit a Biologics License Application to the FDA in early 2027. Federal regulators have warned consumers not to buy unapproved versions of the drug online.
If approved, retatrutide could become available for chronic weight management, type 2 diabetes, sleep apnea, and osteoarthritis as early as late 2027.