With an obesity green light already in hand, Eli Lilly is pushing for its newly launched Foundayo (orforglipron) to break into Type 2 diabetes, in turn rounding out its oral offering in line with Novo Nordisk’s duo of GLP-1 pills in both indications.
Now, in results from a trio of pivotal phase 3 studies presented Monday at the American Diabetes Association 2026 Scientific Sessions, Lilly is aiming its diabetes data squarely at two of the oral GLP-1’s biggest potential rivals.
Sure to grab the most attention at the conference are results from Achieve-3, a head-to-head trial in which Foundayo topped Novo’s oral semaglutide on metrics of blood sugar reduction and weight loss in T2D patients.
Prior to the launch of the Wegovy pill, Novo had boasted an oral semaglutide formulation for Type 2 diabetes since 2019 called Rybelsus. In early May, Novo—recognizing the impressive brand recognition of its injectable diabetes incretin Ozempic—re-launched its oral T2D offering via a slightly tweaked formulation now being marketed as the Ozempic pill.
Lilly’s head-to-head utilized oral semaglutide dosing from before the brand change, pitting 7- and 14-mg doses of Novo’s oral against 9- and 17.2-mg doses of Foundayo.
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Breaking down the numbers in Achieve-3, Foundayo helped lower patients’ A1C by an average of 1.9% and 2.2% on the 9- and 17.2-mg doses, respectively, compared to 1.1% for 7-mg oral semaglutide and 1.4% for its 14-mg dose at 52 weeks. That worked out to a 57.1% greater relative reduction on Foundayo at the highest dose comparison, Lilly said in a release Monday.
Additionally, 37.1% of patients on the highest dose of Foundayo were able to achieve an A1C of less than 5.7%—within the threshold for normal blood sugar levels—compared to just 12.5% of patients on the top dose of oral semaglutide tested.
On weight loss, the title again went to Lilly’s oral GLP-1 over Novo’s across all doses: Patients were able to lose around 9.2% of their weight on average, or about 19.7 pounds, on 17.2-mg Foundayo, compared to an average reduction of 5.3%, or 11 pounds, on 14-mg oral semaglutide.
Lilly’s data utilized the efficacy estimand, meaning that the data reflect results if all patients adhered properly to their treatment regimens. Persistence and adherence pose ongoing hurdles for incretin meds, especially in the obesity setting where higher doses often lead to unpleasant gastrointestinal side effects.
Thomas Seck, SVP of product development for Lilly cardiometabolic health, said during a fireside chat at the Scientific Sessions that the head-to-head results are “substantial.”
On safety, Seck noted that Foundayo’s profile was “consistent” with the GLP-1 class more broadly. Overall, he stressed that he believes Achieve-3 will serve as a “very robust study” that should help inform healthcare practitioners’ treatment decisions when forced to choose between several promising anti-diabetes medicines.
While oral semaglutide is no doubt Foundayo’s chief rival among the GLP-1 class, Lilly also used the ADA Scientific Sessions in New Orleans to demonstrate its drug’s potential to improve upon a more storied diabetes treatment in AstraZeneca’s SGLT2 blockbuster Farxiga (dapagliflozin).
AZ’s medication, also a tablet taken by mouth, won its initial Type 2 diabetes nod from the FDA back in 2014 and his since lassoed expansions to reduce heart failure hospitalization risk in those same patients. Additionally, the drug has secured approvals in certain heart failure and kidney disease uses, among others.
In Lilly’s Achieve-2 trial, Foundayo helped lower A1C by up to an average of 1.7%, from a baseline of 8.1%, versus 0.8% for Farxiga at the study’s 40-week mark. Meanwhile, up to 68.6% of patients on the highest 17.2-mg Foundayo dose achieved an A1C less than or equal to 6.5%, which is the level recommended for more intensive blood sugar control, according to Lilly. In contrast, a little less than 22% of patients on Farxiga hit that A1C benchmark.
Foundayo also trumped Farxiga on weight loss in the trial, which enrolled 962 participants with Type 2 diabetes and inadequate glycemic control with metformin.
Lilly rounded things out with a third trial from the program, Achieve-5, which similarly fell in Foundayo’s favor when it came to blood sugar level lowering and weight loss when pitted against placebo on top of titrated insulin glargine over 40 weeks.
Back in April, mere days after Foundayo’s launch as an oral option for obesity treatment, Lilly rolled out results from Achieve-4, a phase 3 study in which Foundayo proved its non-inferiority to insulin glargine in adult Type 2 diabetes patients who have obesity or are overweight and at increased cardiovascular risk. Alongside demonstrating superiority to insulin glargine on blood sugar level improvement and weight loss, the risk of major adverse cardiovascular events (MACE) was 16% lower in the Foundayo cohort as compared to the insulin arm.
At the time, Lilly said it would use the data package to file Foundayo for a potential U.S. diabetes nod by the end of the second quarter. Lilly has said it aims to use one of the FDA’s Commissioner’s National Priority Review Vouchers for its filing, adding the potential for Foundayo’s review to be completed in a span of just a few months.