Lilly seeks FDA approval for its GLP-1 weight loss pill

Eli Lilly's closely watched obesity pill, orforglipron, helped people in a late-stage study maintain weight loss for up to a year after switching from injectable GLP-1 drugs, the company announced today.

The weight loss pill could be a promising solution to the problems commonly observed when patients stop GLP-1 therapy, especially weight gain.

In the phase 3, first-of-its-kind trial, patients who took Lilly's oral GLP-1 therapy for 52 weeks, after taking Zepbound or Novo Nordisk's Wegovy for 72 weeks, largely maintained their weight loss for up to a year.

Orforglipron achieved the study's main goal of helping participants who previously plateaued while using injectables maintain more of their weight loss than those who took a placebo, pointing to a potential new use for oral GLP-1 drugs.

The findings show that patients who switched to orforglipron from Wegovy regained roughly 2 pounds, while those previously taking Zepbound regained roughly 11 pounds -- an average maintenance of 80–95%.

Safety and tolerability were on par with those of previous orforglipron phase 3 studies, Lilly said -- with most reported side effects being gastrointestinal and generally mild to moderate in severity.

Across all groups, fewer than 8% of patients discontinued treatment due to side effects. However, slightly more patients who took Lilly's Zepbound before taking orforglipron discontinued than those in the placebo group.

Orforglipron has officially been submitted for FDA approval to treat obesity, Lilly also confirmed in its news release.

In a market that is anticipated to see a number of new competitors, an oral obesity pill would help Lilly solidify its lead in the weight loss space.

Earlier this year, Lilly's main rival, Novo Nordisk, submitted the oral version of its blockbuster weight loss drug, Wegovy, to the FDA. But then, both companies were awarded a fast-track voucher for their pills last month under the National Priority program.

Although Novo's oral weight loss drug is expected to be approved first, the two could end up hitting the market at roughly the same time, with a decision on Wegovy expected at the end of this month and Lilly's orforglipron early next year.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.