Lilly reports Foundayo beat oral semaglutide on blood sugar and weight in three type 2 diabetes trials

Eli Lilly released detailed results on June 8, 2026, from three Phase 3 trials of its oral GLP-1 pill Foundayo (orforglipron) in adults with type 2 diabetes ^[1][2]. In the head-to-head ACHIEVE-3 trial, Foundayo produced larger average reductions in blood sugar and weight than oral semaglutide, the company said. The results were presented at the American Diabetes Association's 86th Scientific Sessions, with ACHIEVE-3 and ACHIEVE-2 published in The Lancet and ACHIEVE-5 in JAMA ^[1][2].

ACHIEVE-3 enrolled 1,698 adults whose blood sugar was not adequately controlled on metformin ^[1][2]. Participants started with an average A1C of 8.3% ^[1][2]. At 52 weeks, Foundayo lowered A1C by an average of 1.9% at the 9 mg dose and 2.2% at 17.2 mg, compared with 1.1% for oral semaglutide 7 mg and 1.4% for oral semaglutide 14 mg ^[1][2]. Lilly described the highest-dose comparison as a 57.1% greater relative reduction ^[1][2]. Average weight loss was 14.6 pounds (6.7%) on Foundayo 9 mg and 19.7 pounds (9.2%) on 17.2 mg, versus 7.9 pounds (3.7%) and 11.0 pounds (5.3%) for the two oral semaglutide doses ^[1][2]. Among participants on Foundayo 17.2 mg, 37.1% reached an A1C below 5.7%, the threshold for normal blood sugar, compared with 12.5% on oral semaglutide 14 mg ^[1][2].

ACHIEVE-2 randomized 962 adults taking metformin to Foundayo or dapagliflozin for 40 weeks ^[1][2]. Foundayo lowered A1C by up to an average of 1.7% versus 0.8% for dapagliflozin, from a baseline average of 8.1% ^[1][2]. Up to 68.6% of patients on the highest Foundayo dose reached an A1C of 6.5% or below, compared with 21.6% on dapagliflozin ^[1][2]. Average weight loss ranged from 7.1 pounds (2.5 mg) to 15.0 pounds (17.2 mg), versus 6.0 pounds on dapagliflozin ^[1][2].

ACHIEVE-5 randomized 546 adults not adequately controlled on insulin glargine to Foundayo or placebo for 40 weeks ^[1][2]. Foundayo lowered A1C by up to an average of 2.1% versus 0.8% for placebo, from a baseline of 8.5% ^[1][2]. Up to 69.1% of those taking Foundayo 9 mg reached an A1C of 6.5% or below, compared with 11.1% on placebo ^[1][2]. Average weight loss ranged from 4.9 to 11.5 pounds across doses, compared with an average gain of 1.1 pounds on placebo ^[1][2].

The most common side effects across the three trials were gastrointestinal, including nausea, diarrhea, vomiting, dyspepsia and decreased appetite ^[1][2]. Discontinuation rates due to side effects were higher with Foundayo than with the comparison treatments in each trial: 8.7% and 9.7% for Foundayo 9 mg and 17.2 mg versus 4.5% and 4.9% for oral semaglutide in ACHIEVE-3; 9.2%, 10.8% and 12.4% across Foundayo doses 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][2]. Lilly said the overall safety and tolerability profile was consistent with earlier studies ^[1][2]. The trials used an investigational formulation of Foundayo at dosages equivalent to Foundayo tablets ^[1][2].

Why it matters for patients

Foundayo is already FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems, but it is not approved for type 2 diabetes ^[1][2]. Lilly's labeling states it should not be used with other GLP-1 receptor agonist medicines ^[1][2]. If the FDA clears the diabetes filing, the pill would become another oral option for people who prefer not to inject. Lilly says Foundayo can be taken any time of day without restrictions on food or water intake ^[1][2].

The results also come with context. ACHIEVE-3 and ACHIEVE-2 were open-label, meaning participants knew which treatment they received; ACHIEVE-5 was double-blind ^[1][2]. And in all three trials, more people stopped Foundayo because of side effects than stopped the comparison treatment. Whether those rates would look the same in routine practice has not been reported.

What happens next

Lilly said it plans to submit Foundayo to the FDA for type 2 diabetes by the end of the second quarter of 2026, under the Commissioner's National Priority Review Voucher ^[1][2]. The company has not disclosed a price for a diabetes indication, an expected FDA decision date, or a full list of the diabetes trial data still to be presented. Orforglipron is also being studied for obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence ^[1][2].