user Admin_Adham
23rd Jul, 2026 12:00 AM
Test

Lilly Announces More Next-gen Obesity Drug Data, Plans Q1 2027 FDA Application

July 23 (Reuters) - Eli Lilly said on Thursday that two more Phase 3 trials of its experimental obesity drug retatrutide showed positive results and it plans to submit ⁠an application to the U.S. Food and Drug Administration in the first quarter of next year.

Retatrutide is designed to target three different metabolic hormones: GLP-1, GIP and glucagon. ⁠The company's current injectable obesity drug, Zepbound, targets GLP-1 and GIP, while rival Novo Nordisk's Wegovy targets just GLP-1.

Lilly said an 80-week trial ⁠of adults with severe obesity and established heart ‌disease showed average weight loss of 22.6% for the highest weekly dose of retatrutide.

Analysts said the data reinforced retatrutide's best-in-class weight-loss potential, but was unlikely to move the stock significantly given high expectations.

"The weight-loss results are no longer headline-grabbing given prior retatrutide data, but further strengthen its position within Lilly's expanding cardiometabolic portfolio," Citi analysts said.

SUGGESTED FOR YOU

Lilly shares were down about 1% in premarket trading.

The ‌company said major cardiovascular events occurred less frequently than expected in both the treatment and placebo groups. But ​when measuring ‌just the three most severe events - heart attack, stroke and ‌death - patients on retatrutide had a 12% higher risk than the placebo group.

The cardiovascular events dataset was limited, making the imbalance difficult to interpret, BMO ⁠Capital analysts said. They, however, added that the directional benefit among patients ‌who remained on treatment was encouraging.

A ⁠different 80-week trial of overweight or obese patients ​who also had type 2 diabetes showed that participants given ‌the highest dose lost 20.8% of their body weight and lowered A1C levels by 1.6%.

The most common side effects in both trials were nausea and diarrhea.

Lilly had previously announced that patients with obesity but not diabetes lost an average of 28.3% ​of their weight in an 80-week trial of retatrutide. Positive results were also ‌seen ‌in Phase 3 studies of the drug's impact on knee osteoarthritis pain and obstructive sleep apnea.

"Across five positive Phase 3 studies, retatrutide ‌has shown powerful efficacy, and ​we believe it could be an important future tool in the management of cardiometabolic health," Lilly Executive Vice President Kenneth Custer said in a statement.

Lilly said it plans to submit a biologics license application for retatrutide to the ⁠FDA in the first quarter of next year. The company also said full results of the ‌latest trials will be published in medical journals at a later date.

(Reporting ; Additional reporting by Mariam Sunny ​in Bengaluru; Editing by Chris Reese and Anil D'Silva)


Share This Article

Comments

Leave a comment