Eli Lilly says GLP-1 pill for diabetes and weight loss effective in study, plans to seek FDA approval

Eli Lilly and Co., the maker of Zepbound and Mounjaro, announced success Thursday of its Phase 3 clinical trial for a once-daily GLP-1 pill — an oral form of the blockbuster medication used for diabetes and weight loss.

The trial of the drug, orforglipron, measured its efficacy and safety in adults with Type 2 diabetes compared to a placebo. It found the pill lowered A1C, a blood level used to diagnose diabetes, by an average of 1.3% to 1.6%, across different doses, after 40 weeks. 

Participants taking the highest dose also lost an average of 16 pounds. 

“Given that participants had not yet reached a weight plateau at the time the study ended, it appears that full weight reduction was not yet attained,” the company said in a news release. It did not include information on the demographics of the people who participated in the trial.

The most commonly reported adverse effects were mild to moderate gastrointestinal issues, including diarrhea, nausea, indigestion, constipation and vomiting. 

The pill, which would offer an alternative to injections, is the first small molecule oral GLP-1 to succeed in a Phase 3 trial, the company said. 

Eli Lilly says it plans to submit orforglipron to the U.S. Food and Drug Administration for approval as a Type 2 diabetes treatment in 2026. For weight management, it plans to submit the drug to global regulatory agencies by the end of this year. 

“If approved, the company is confident in its ability to launch orforglipron worldwide without supply constraints,” the news release said. “This would further Lilly’s mission to reduce chronic diseases like type 2 diabetes, which is expected to impact an estimated 760 million adults by 2050.”