ACHIEVE-2, ACHIEVE-3 and ACHIEVE-5 presented at ADA 2026

Eli Lilly on June 8, 2026 released detailed results from the last three Phase 3 trials of Foundayo (orforglipron) in adults with type 2 diabetes, presented at the American Diabetes Association's 86th Scientific Sessions ^[1]. ACHIEVE-3 was previously published in The Lancet, while ACHIEVE-2 and ACHIEVE-5 were published in The Lancet and JAMA, respectively ^[1]. Lilly said it plans to submit Foundayo for type 2 diabetes to the FDA by the end of the second quarter, using the Commissioner's National Priority Review Voucher ^[1].

Foundayo is a once-daily small-molecule (non-peptide) GLP-1 pill that can be taken any time of day without restrictions on food or water ^[1]. It is already FDA-approved in the U.S. for adults with obesity, or some adults with overweight plus a weight-related health problem, alongside a reduced-calorie diet and more physical activity ^[1]. Type 2 diabetes would be a separate indication.

The head-to-head result

ACHIEVE-3 randomized 1,698 adults whose diabetes was not adequately controlled on metformin, across the U.S., Argentina, China, Japan, Mexico and Puerto Rico, to Foundayo 9 mg or 17.2 mg, or oral semaglutide (the tablet form, sold as Rybelsus) 7 mg or 14 mg ^[1]. At 52 weeks, A1C fell an average of 1.9% (Foundayo 9 mg) and 2.2% (17.2 mg), versus 1.1% and 1.4% for oral semaglutide 7 mg and 14 mg, from a baseline of 8.3% ^[1]. That is a 57.1% greater relative reduction at the top doses ^[1].

Weight loss also favored Foundayo: 14.6 lbs (6.7%) at 9 mg and 19.7 lbs (9.2%) at 17.2 mg, compared with 7.9 lbs (3.7%) and 11.0 lbs (5.3%) with oral semaglutide, from an average starting weight of 213.9 lbs ^[1]. An A1C below 5.7% — described in the release as the threshold for normal blood sugar — was reached by 37.1% on Foundayo 17.2 mg versus 12.5% on oral semaglutide 14 mg, though that endpoint was not controlled for family-wise type 1 error ^[1].

The other two trials

ACHIEVE-2 enrolled 962 adults on metformin and compared Foundayo 2.5 mg, 9 mg and 17.2 mg with dapagliflozin 10 mg, an SGLT-2 pill ^[1]. At 40 weeks, A1C fell up to 1.7% with Foundayo versus 0.8% with dapagliflozin from a baseline of 8.1%, and up to 68.6% of those on the highest Foundayo dose reached an A1C of 6.5% or lower versus 21.6% with dapagliflozin ^[1]. Weight loss was 7.1 lbs (2.5 mg), 12.8 lbs (9 mg) and 15.0 lbs (17.2 mg), versus 6.0 lbs with dapagliflozin ^[1].

ACHIEVE-5 randomized 546 adults already on insulin glargine to Foundayo or placebo ^[1]. A1C dropped up to 2.1% versus 0.8% with placebo at 40 weeks from a baseline of 8.5%, and 69.1% of the 9 mg group hit an A1C of 6.5% or lower versus 11.1% on placebo ^[1]. Foundayo groups lost 4.9 to 11.5 lbs; the placebo group gained 1.1 lbs ^[1].

Side effects were mostly gastrointestinal — nausea, diarrhea, vomiting, dyspepsia and decreased appetite ^[1]. Discontinuations due to adverse events were 8.7% (9 mg) and 9.7% (17.2 mg) versus 4.5% and 4.9% for oral semaglutide in ACHIEVE-3; 9.2%, 10.8% and 12.4% versus 1.2% for dapagliflozin in ACHIEVE-2; and 3.6%, 7.6% and 9.6% versus 3.6% for placebo in ACHIEVE-5 ^[1].

Why it matters for patients

This is the first time two oral GLP-1 medicines have been compared directly in a Phase 3 diabetes trial ^[1]. For people who prefer a pill over an injection, the data give a concrete sense of how the two options differ on A1C and weight — at least at the oral semaglutide doses approved for diabetes ^[1].

The doses also matter for reading past coverage. Lilly noted the trials used an investigational formulation at dosages equivalent to Foundayo tablets, and the results are now stated in tablet strengths of 2.5 mg, 9 mg and 17.2 mg, reached by stepping up from 0.8 mg at four-week intervals ^[1].

One caveat: higher discontinuation rates on Foundayo than on the comparators suggest more people stopped because of side effects ^[1]. And Foundayo is not currently approved for type 2 diabetes in the U.S.; whether and when the FDA clears that use is not yet known.

What happens next

Lilly said the FDA submission for type 2 diabetes will come by the end of the second quarter of 2026 — June 30 — supported by ACHIEVE-1 through ACHIEVE-5 ^[1]. The company has not disclosed an expected decision date, and pricing or coverage for a diabetes indication has not been announced ^[1].