Lilly says oral Foundayo beat comparators on blood sugar in three type 2 diabetes trials

Eli Lilly said its once-daily oral GLP-1 pill Foundayo (orforglipron) delivered larger blood sugar reductions than the medicines it was tested against in three phase 3 trials in adults with type 2 diabetes ^[1][2]. The results were presented at the American Diabetes Association's 2026 Scientific Sessions in New Orleans, held June 5-8, with companion publications in The Lancet and JAMA ^[2].

The three trials are part of the ACHIEVE program. HbA1c, the standard measure of average blood sugar, is reported in percent in the US and in mmol/mol in the UK and elsewhere; the meeting report gives figures in mmol/mol ^[2].

What the three trials found

ACHIEVE-2 compared orforglipron with dapagliflozin in 962 adults with type 2 diabetes whose HbA1c was 7.0-10.5% despite metformin ^[2]. Mean HbA1c fell by 13.4, 16.4 and 17.0 mmol/mol with orforglipron 3 mg, 12 mg and 36 mg, compared with 8.9 mmol/mol with dapagliflozin (P<0.001 for all comparisons) ^[2]. The 12 mg and 36 mg doses produced more weight loss than dapagliflozin ^[2]. Drugs.com describes the same result as an A1c reduction of "up to 1.7% compared to 0.8% with dapagliflozin" ^[1], a percentage figure that does not match the mmol/mol numbers exactly. The trial ran 40 weeks ^[2].

ACHIEVE-3 was a 52-week, open-label study of 1,698 adults with type 2 diabetes and suboptimal control on metformin ^[2]. Orforglipron 12 mg and 36 mg were compared with oral semaglutide 7 mg and 14 mg. From a baseline HbA1c of 8.3%, mean HbA1c fell by 18.7 and 20.9 mmol/mol with the two orforglipron doses, versus 13.4 and 16.0 mmol/mol with oral semaglutide. Both non-inferiority and superiority were met ^[2]. Drugs.com reports the same trial as a 2.2% reduction with orforglipron 36 mg versus 1.4% with oral semaglutide 14 mg, plus weight loss of 19.7 pounds (9.2%) versus 11.0 pounds (5.3%) ^[1].

ACHIEVE-5 tested orforglipron as an add-on to insulin glargine in 546 people whose median diabetes duration was 14.6 years; 507 completed the 40-week trial ^[2]. HbA1c fell by 17.2-20.5 mmol/mol with orforglipron versus 8.6 mmol/mol with placebo, and body weight fell 2.6-5.4% versus 0.2%. The risk of clinically significant hypoglycemia was not higher with orforglipron than with placebo ^[2]. Lead author Francesco Giorgino said that "for many patients, basal insulin alone is not enough to maintain glycaemic control," and that an oral GLP-1 therapy "could offer a simpler alternative to intensifying insulin treatment" ^[2].

Safety

Side effects across the trials were typical of the GLP-1 class: mostly gastrointestinal and generally mild to moderate, occurring mainly during dose increases and easing over time ^[2]. Discontinuations because of side effects were more common with orforglipron than with dapagliflozin in ACHIEVE-2 and more common than with oral semaglutide in ACHIEVE-3, which also saw a mean increase in pulse rate with orforglipron ^[2]. Foundayo carries a boxed warning for thyroid C-cell tumors; listed warnings also include pancreatitis, severe gastrointestinal reactions, acute kidney injury, hypoglycemia, serious allergic reactions, gallbladder disease and diabetic retinopathy complications in people with type 2 diabetes ^[1].

Why it matters for patients

Foundayo was approved by the FDA on April 1, 2026, for weight loss in adults with obesity, or with overweight plus at least one weight-related condition. It is not approved for type 2 diabetes ^[1]. Outside the US, orforglipron was not approved for any use in the UK as of the meeting report ^[2]. The new ACHIEVE data therefore describe what the pill can do for blood sugar without changing what patients can currently get it for.

For anyone comparing oral and injectable GLP-1 options, ACHIEVE-3 is the head-to-head test that matters most: it pitted orforglipron against oral semaglutide, the other GLP-1 pill. Foundayo's label says it is taken once daily with or without food or water restrictions ^[1].

What happens next

Whether Lilly has filed with the FDA for a type 2 diabetes indication for Foundayo has not been reported, and no decision date for such a review has been disclosed. Lilly has separately reported results in obstructive sleep apnea and hypertension in adults with obesity as areas still under study ^[1].