First GLP-1 pill for weight loss, diabetes shows success in late-phase trial
Eli Lilly announced Thursday the successful completion of a phase 3 trial of Orforglipron – the first small-molecule GLP-1 that is administered as a once-daily oral pill.
The ACHIEVE-1 trial evaluated the efficacy of Orforglipron compared to placebo in adults with type 2 diabetes and "inadequate glycemic control with diet and exercise alone."
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The results showed lowered A1C (blood sugar) in patients by an average of 1.3% to 1.6% across doses, according to a press release.
More than 65% of participants taking the highest dose of the drug scored an A1C less than or equal to 6.5%, which is below the defined threshold for diabetes, according to the American Diabetes Association.
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Trial participants also saw reduced weight by an average of 16 pounds, or 7.9%, at the highest dose.
Participants had not reached a weight plateau when the study ended, which suggests there was still weight to be lost, according to the researchers.
The trial also found that the overall safety and tolerability of the drug was consistent with the classic injectable GLP-1s, like Ozempic, Wegovy, Mounjaro and Zepbound.
If Orforglipron achieves approval by the U.S. Food and Drug Administration, Eli Lilly projected its confidence in launching the drug "worldwide without supply constraints."
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"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," the pharmaceutical company wrote in its announcement.
David A. Ricks, Eli Lilly chair and CEO, commented in a statement, "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."
"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."
Eli Lilly intends to submit Orforglipron for weight management to global regulatory agencies by the end of 2025, as well as for type 2 diabetes treatment in 2026, according to the company.Original article source: First GLP-1 pill for weight loss, diabetes shows success in late-phase trial
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