INDIANAPOLIS, USA – June 8, 2026
Eli Lilly and Company has reported compelling new Phase 3 clinical data showing that Foundayo (orforglipron), its once-daily oral GLP-1 receptor agonist, achieved superior blood sugar control and weight loss across three pivotal ACHIEVE clinical trials in adults with type 2 diabetes. Presented at the American Diabetes Association (ADA) 86th Scientific Sessions, the results position Foundayo as a potential first-line oral treatment option capable of delivering meaningful improvements in glycemic control and weight management without food or water restrictions. The findings further strengthen Lilly’s growing leadership in the rapidly expanding diabetes and obesity market and support the company’s planned regulatory submission for type 2 diabetes treatment in the United States. The data demonstrated consistent efficacy across diverse patient populations, reinforcing confidence in the medicine’s potential to reshape the treatment landscape for millions of people living with type 2 diabetes.
Foundayo Delivers Superior A1C Reduction and Weight Loss
The most notable findings came from the ACHIEVE-3 Phase 3 study, the first head-to-head trial comparing two oral GLP-1 therapies. In the study, Foundayo 17.2 mg delivered a 57.1% greater relative reduction in A1C and a 73.6% greater relative weight loss compared with oral semaglutide 14 mg, meeting both primary and key secondary endpoints. Patients receiving Foundayo achieved average A1C reductions of up to 2.2%, compared with 1.4% for oral semaglutide, while weight loss reached 19.7 pounds versus 11.0 pounds for the comparator treatment. Importantly, a significantly greater proportion of participants achieved normal blood sugar levels, with 37.1% reaching an A1C below 5.7%, compared with 12.5% among patients receiving oral semaglutide. These results highlight Foundayo’s potential to deliver superior clinical outcomes while offering the convenience of an oral formulation.
Strong Performance Across Multiple Pivotal Studies
Additional evidence came from the ACHIEVE-2 and ACHIEVE-5 trials, where Foundayo consistently demonstrated significant advantages over established treatment options. In ACHIEVE-2, the therapy outperformed dapagliflozin, achieving A1C reductions of up to 1.7% compared with 0.8% for the comparator. Up to 68.6% of participants receiving the highest Foundayo dose reached the clinically important A1C target of ≤6.5%, compared with only 21.6% of those treated with dapagliflozin.
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Meanwhile, ACHIEVE-5 showed significant improvements when Foundayo was added to insulin glargine therapy, reducing A1C by up to 2.1% versus 0.8% with placebo. Nearly 69.1% of participants achieved A1C levels of ≤6.5%, demonstrating robust glucose-lowering efficacy even among patients requiring insulin-based treatment. Across all studies, patients experienced meaningful weight loss and improvements in key cardiovascular risk markers, including cholesterol levels, triglycerides, and systolic blood pressure.
Lilly Advances Toward Regulatory Submission
The positive results further support Lilly’s strategy of expanding access to innovative oral GLP-1 therapies. According to the company, the overall safety and tolerability profile of Foundayo remained consistent with previous studies, with gastrointestinal events such as nausea, diarrhea, vomiting, and decreased appetite representing the most commonly reported side effects. Importantly, the medicine offers a unique advantage as a once-daily oral GLP-1 receptor agonist that can be taken at any time without food or water restrictions, potentially improving patient adherence and convenience.
Based on data from the broader ACHIEVE clinical program, Lilly plans to submit Foundayo for the treatment of type 2 diabetes to the U.S. Food and Drug Administration by the end of the second quarter. As competition intensifies in the diabetes and obesity sector, the latest findings suggest that Foundayo could emerge as one of the most significant oral metabolic therapies in development, offering patients a highly effective alternative to injectable treatments while strengthening Lilly’s position in one of the pharmaceutical industry’s fastest-growing therapeutic markets.
Source: Eli Lilly press release
