Eli Lilly (NYSE:LLY) on Wednesday posted detailed data from its ATTAIN-1 Phase 3 trial for its oral GLP-1 receptor agonist, orforglipron as presented at a European medical event and simultaneously published in The New England Journal of Medicine.
Shares of the Indiana-based drugmaker slipped last month in reaction to initial results from the 72-week trial, which tested orforglipron at 6 mg, 12 mg, and 36 mg as monotherapy in obese or overweight adults with at least one weight-related medical condition and no diabetes. Novo Nordisk (NVO), LLY’s rival in the obesity space whose oral version of popular weight loss therapy semaglutide is currently under FDA review, traded higher.
As announced previously, LLY said all three doses reached ATTAIN-1’s main goal related to body weight reduction compared to placebo, with those on orforglipron experiencing an average weight loss of 27.3 lbs (12.4%), according to a per-protocol analysis.
The study also met the key secondary endpoints related to the reduction of body weight and waist circumference with a clinically meaningful impact.
As for safety, LLY said nausea, constipation, diarrhea, and gastrointestinal adverse events were among the commonly found adverse events, which were mild-to-moderate in severity.
While roughly 3% of those on placebo discontinued the trial, discontinuation rates for 6 mg, 12 mg, and 36 mg of orforglipron were approximately 5%, 8%, and 10%, respectively.
The company said plans are underway to submit marketing applications for the once-daily pill for obesity, with a regulatory action expected next year. Its moves to seek regulatory nod for orforglipron in diabetes are expected to begin next year.