Key Takeaways:
Key Takeaways:
Eli Lilly & Co.'s oral GLP-1 Foundayo (orforglipron) outperformed Novo Nordisk's oral semaglutide in the first head-to-head Phase 3 trial of two oral GLP-1 receptor agonists for type 2 diabetes, with patients on the 17.2 mg dose achieving a 2.2 percentage-point reduction in A1C from a baseline of 8.3% compared with 1.4 points for oral semaglutide 14 mg at 52 weeks, a 57.1% greater relative reduction.
"The results support a potential shift toward using oral GLP-1 receptor agonist therapies like orforglipron earlier as a foundation of type 2 diabetes care," Dr. Julio Rosenstock, clinical professor of medicine at the University of Texas Southwestern Medical Center and ACHIEVE-3 lead investigator, said in a statement.
Foundayo also drove greater weight loss, with patients on the 17.2 mg dose losing an average of 19.7 pounds (9.2%) compared with 11 pounds (5.3%) for oral semaglutide 14 mg, a 73.6% greater relative reduction. Across the three ACHIEVE trials presented at the American Diabetes Association's 86th Scientific Sessions, Foundayo consistently delivered superior A1C control and weight loss versus both dapagliflozin in ACHIEVE-2 and placebo added to insulin glargine in ACHIEVE-5. In ACHIEVE-2, up to 68.6% of patients on Foundayo achieved an A1C of 6.5% or below compared with 21.6% on dapagliflozin. In ACHIEVE-5, up to 69.1% reached that threshold versus 11.1% on placebo.
The results position Lilly to challenge Novo Nordisk's dominance in the oral GLP-1 market as the company prepares to submit Foundayo for type 2 diabetes to the U.S. Food and Drug Administration by the end of the second quarter under a National Priority Review Voucher. Foundayo, already approved for chronic weight management, is a once-daily small molecule taken without food or water restrictions, offering a convenience advantage over injectable GLP-1s and oral semaglutide, which requires fasting. The most common adverse events across all three trials were gastrointestinal, with discontinuation rates due to adverse events reaching 9.7% on the 17.2 mg dose in ACHIEVE-3 compared with 4.9% on oral semaglutide 14 mg.
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