Eli Lilly and Company, maker of Zepbound (tirzepatide) and Foundayo (orforglipron), has said that its investigational drug retatrutide produced substantial weight loss and blood-sugar improvements in adults with type 2 diabetes and obesity.
With the highest dose delivering an average 20.8% reduction in body weight, Eli Lilly said as it unveiled detailed results from the Phase 3 TRIUMPH-2 trial.
Retatrutide is an investigational, first-in-class combination of GIP, GLP-1 and glucagon receptor activity. The results were presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Milan and published simultaneously in The Lancet.
Participants receiving 4 mg, 9 mg and 12 mg of retatrutide lost an average of 12.7%, 19.1% and 20.8% of their body weight, respectively.
The highest dose produced even greater weight loss among people who entered the trial with a BMI of at least 35. That group lost an average of 23.4% of body weight, or 60.8 pounds.
By the end of the 80-week study, 59.5% of participants receiving 12 mg no longer met the BMI criteria for obesity, according to Lilly.
"The vast majority of people with type 2 diabetes are also living with obesity, and treating the two together has always been a challenge," said Juan P. Frías, Medical Director and Principal Investigator, Los Angeles Institute for Metabolic Research.
"In TRIUMPH-2, retatrutide reduced both weight and blood sugar substantially, with more than half of participants no longer qualifying as having obesity and up to 40% reaching an A1C in the normal range. Results such as these may change what we set out to achieve with a single therapy for adults living with type 2 diabetes and obesity."
The weight-loss results were accompanied by meaningful reductions in A1C, a key measure of longer-term blood-sugar control.
Average A1C reductions were 1.4% with the 4 mg dose, 1.6% with 9 mg and 1.5% with 12 mg. Lilly said up to 40% of participants reached an A1C below 5.7%, the threshold generally considered within the normal range.
Retatrutide also improved several cardiovascular risk markers.
"TRIUMPH-2 shows what the next generation of cardiometabolic medicine could deliver: substantial weight loss, A1C reduction and improvements across other critical cardiovascular risk factors," said Kenneth Custer, executive vice president and president, Lilly Cardiometabolic Health.
"With efficacy this powerful and consistent across our Phase 3 program, we believe retatrutide could become an important option for people living with type 2 diabetes and obesity."
The most frequently reported adverse events were gastrointestinal.
Lilly said the events were generally mild to moderate and that most resolved during treatment.
Discontinuation because of adverse events occurred in 3.8% of participants taking 4 mg, 11.6% taking 9 mg and 7.7% taking 12 mg, compared with 4.9% for placebo.
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