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

Orforglipron is the first small molecule GLP-1 to successfully complete a Phase 3 trial, lowering A1C by an average of 1.3% to 1.6% across doses.

INDIANAPOLIS— Eli Lilly and Co. 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.

"ACHIEVE-1 is the first of seven Phase 3 studies examining the safety and efficacy of orforglipron across people with diabetes and obesity. We are pleased to see that our latest incretin medicine meets our expectations for safety and tolerability, glucose control and weight loss, and we look forward to additional data readouts later this year," said David A. Ricks, Lilly chair and CEO. "As a convenient once-daily pill, orforglipron may provide a new option and, if approved, could be readily manufactured and launched at scale for use by people around the world."

The ACHIEVE-1 results will be presented at ADA's 85th Scientific Sessions and published in a peer-reviewed journal. More results from the ACHIEVE Phase 3 clinical trial program will be shared later this year, along with findings from the ATTAIN Phase 3 clinical trial program evaluating orforglipron for weight management. Lilly expects to submit orforglipron for weight management to global regulatory agencies by the end of this year, with the submission for the treatment of type 2 diabetes anticipated in 2026.  

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