Eli Lilly has reported detailed Phase III results from three ACHIEVE trials evaluating Foundayo, or orforglipron, an oral GLP-1 receptor agonist for adults with type 2 diabetes.
The data come as demand for GLP-1 therapies continues to reshape diabetes and obesity care. Injectable GLP-1 therapies have demonstrated strong clinical value, but oral options that can be taken without food or water restrictions may improve convenience, adherence and broader scalability in routine metabolic disease management.
In the ACHIEVE-3 head-to-head trial, Foundayo outperformed oral semaglutide across the primary and key secondary endpoints. At 52 weeks, Foundayo lowered A1C by 1.9 percent at 9 mg and 2.2 percent at 17.2 mg, compared with 1.1 percent and 1.4 percent reductions for oral semaglutide 7 mg and 14 mg, respectively.
The highest Foundayo dose also produced greater weight loss, with patients losing an average of 19.7 pounds, or 9.2 percent, compared with 11.0 pounds, or 5.3 percent, for oral semaglutide 14 mg. This represented a 73.6 percent greater relative weight loss at the highest-dose comparison.
In ACHIEVE-2 and ACHIEVE-5, Foundayo met the primary and key secondary endpoints, showing superior A1C reduction and weight loss versus dapagliflozin and placebo added to insulin glargine, respectively. Lilly stated that up to 68.6 percent and 69.1 percent of participants reached an A1C goal of 6.5 percent or lower in ACHIEVE-2 and ACHIEVE-5.
Lilly plans to submit Foundayo for type 2 diabetes to the US FDA by the end of the second quarter. If approved, the therapy could become an important oral alternative in a market currently shaped by injectable GLP-1 and incretin-based medicines.
The results reinforce the rapid evolution of metabolic disease treatment toward more potent and patient-convenient therapies. Oral GLP-1 options may help expand access beyond patients willing or able to use injectables, potentially reshaping earlier treatment strategies in type 2 diabetes.
