Eli Lilly plans early 2027 retatrutide submission after positive trial data

Patients with cardiovascular disease lost nearly 56 pounds on average

Phase 3 data shows nearly 56-pound average weight loss

Eli Lilly said Thursday it is preparing application materials for retatrutide, its next-generation weight-loss drug, following data from two Phase 3 clinical trials that showed substantial weight loss and reductions in cardiovascular risk factors. The company plans to submit the drug to the U.S. Food and Drug Administration for approval in the first quarter of 2027.

In one trial, patients with severe obesity and cardiovascular disease lost an average of nearly 56 pounds after 80 weeks, the company said. Another trial studying overweight or obese patients with type 2 diabetes found that those on a 4-milligram dose lost an average of nearly 13% of their body weight, while patients on a 12-milligram dose lost an average of nearly 21% of their body weight.

Lilly Chief Scientific and Product Officer Daniel Skovronsky described the treatment as likely the “optimal medicine” for people seeking to lose weight or lower their body mass index, adding that the drug sets a “new benchmark” for weight loss. Retatrutide works by mimicking three gut hormones, which helps regulate appetite and can increase a person’s energy expenditure, Skovronsky said.

“At the low dose, we’re seeing efficacy that’s on par with other weight loss drugs at their highest doses, but patients can achieve it quickly with only one step” without gradually titrating up their doses, Skovronsky said.

The trial for patients with cardiovascular disease also showed reductions in triglycerides, non-HDL cholesterol, blood pressure, and inflammation, Skovronsky said.

Lilly said it now has data supporting global submissions for retatrutide to treat obesity, knee osteoarthritis pain, and sleep apnea.

Lilly hopes that an approval for retatrutide as a biologic will help close off a market in counterfeit versions of the drug. More restrictions are placed on compounding and counterfeit versions of biologics, Skovronsky said.

Getting the treatment approved as a biologic would allow the company to “offer a real legitimate alternative that’s made under high quality and studied for safety and efficacy, and then shut down that somewhat dangerous and surely illegal pathway,” he said.