Eli Lilly shared new phase 3 data for its once-daily oral GLP-1 tablet, Foundayo, across a broader set of patient populations than its approved obesity/overweight indication, putting a type 2 diabetes NDA squarely on the horizon.
The biggest new dataset was ACHIEVE-5, a phase 3 trial in 546 adults with long-standing T2D already on basal insulin. All three orforglipron doses (3, 12, and 36 mg) beat placebo on the primary endpoint of HbA1c reduction at week 40 — dropping HbA1c by 1.54% to 2.05% versus just 0.77% with placebo. Weight loss tracked in the same direction: patients on orforglipron lost 2.7% to 6.1% of body weight, while the placebo group actually gained 0.6%.
Separately, a post-hoc analysis of the ATTAIN-1 and ATTAIN-2 trials (the studies that anchored Foundayo's obesity approval) showed the drug worked well across all stages of menopause. At the highest 17.2 mg dose, perimenopausal women in ATTAIN-1 lost up to 14.4% of body weight and postmenopausal women lost up to 14.1% over 72 weeks — figures that hold up well against the injectable competition.
Foundayo was FDA approved in April 2026 for adults with obesity or overweight with weight-related comorbidities. Lilly has said a T2D regulatory submission is expected, which would add a second approved indication to the drug and considerably expand manufacturing demand.