ADA: Lilly bests Novo again, takes GLP-1 pill Foundayo to FDA for diabetes approval

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Newly approved weight loss pill Foundayo reduced blood sugar more than Novo Nordisk’s semaglutide and other comparators in multiple Phase 3 type 2 diabetes trials. Eli Lilly will seek approval in this indication.

Eli Lilly’s oral GLP-1 drug orforglipron—approved as Foundayo for chronic weight management—elicited better blood sugar control than competing diabetes drugs, including Novo Nordisk’s blockbuster therapy semaglutide.

That’s according to data from three Phase 3 studies in the broad ACHIEVE clinical program, focusing on patients who had achieved inadequate glycemic control on metformin and other prior treatments. ACHIEVE-3 compared Foundayo head-to-head against Novo’s oral semaglutide, marketed as Wegovy for weight loss. Meanwhile, ACHIEVE-2 used AstraZeneca’s Farxiga as the control and ACHIEVE-5 used placebo plus insulin glargine.

Lilly presented findings from all three trials Monday at the 2026 American Diabetes Association conference.

Foundayo’s achievements across the ACHIEVE program “further solidify” the drug’s positioning in type 2 diabetes (T2D), BMO Capital Markets told investors in a Monday note, adding that the asset has shown a “consistently competitive profile” in the indication.

At the 52-week follow-up in ACHIEVE-3, a 9-mg dose of Foundayo led to a 1.9% reduction in HbA1c, an indicator of blood sugar levels over the past two to three months. Comparators on 7-mg semaglutide, meanwhile, saw a 1.1% decrease in HbA1c. Foundayo maintained this advantage at higher doses: 17.2 mg of Lilly’s drug drove HbA1c down 2.2%, versus 1.4% with 14 mg of Novo’s drug.

In ACHIEVE-3, 17.2 mg Foundayo elicited 73.6% greater weight loss than 14 mg oral semaglutide.

ACHIEVE-2 and ACHIEVE-5 similarly delivered victories for Foundayo. The GLP-1 cut HbA1c by an average of 1.7% at 40 weeks in ACHIEVE-2, versus 0.8% in controls on Farxiga. The sugar-lowering effect of Foundayo reached up to 2.1% on average at 40 weeks in the latter trial, whereas placebo plus insulin glargine elicited a 0.8% HbA1c drop.

“Orforglipron demonstrated clear benefits in HbA1c reduction and weightloss as an add-on to metformin or insulin glargine when compared to dapagliflozin, semaglutide or placebo,” the analysts wrote. “The consistency of these data across treatment combinations and comparator arms continues to position orforglipron well in the broader landscape of oral T2D therapeutics.”

New data in hand, Lilly is preparing another regulatory run for Foundayo, with a type 2 diabetes submission planned for the second quarter of this year, according to a company announcement on Monday.

“We continue to see an opportunity for orforglipron to compete as a once daily oral treatment with room for multiple winners in T2D,” BMO wrote in its note.

Foundayo won approval in April, marking the next chapter in its heated weight-loss rivalry with Novo, which earned the FDA greenlight for oral Wegovy in late December 2025.

With its thorough victory in the injectables phase of the competition, Lilly is an early favorite in the oral face-off. But Novo has come out swinging with a four-month headstart, better efficacy numbers—16.6% weight loss at 72 weeks for oral Wegovy, versus Foundayo’s 11.2%—and a massively successful launch. There have been no direct head-to-head comparisons of the two drugs in weight loss.

Novo Nordisk and Eli Lilly presented data extolling the benefits of their relative weight loss therapies in obesity-linked indications, while analysts at BMO Capital Markets were “encouraged” by the strategy communicated by Novo management.
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.

Tristan is BioSpace‘s senior staff writer. Based in Metro Manila, Tristan has more than eight years of experience writing about medicine, biotech and science. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.
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