With the green light already in place for obesity, Eli Lilly is moving forward with its newly launched Foundayo (orforglipron) for the treatment of type 2 diabetes, with the goal of creating an oral product to rival Novo Nordisk’s two GLP-1 tablets in both indications.
Now, with results from three pivotal Phase 3 trials presented Monday at the American Diabetes Association’s 2026 Scientific Sessions, Lilly is setting its diabetes data squarely in the crosshairs of two of oral GLP-1’s biggest potential rivals.
The most notable topic at the conference will undoubtedly be the results of Achieve-3, a head-to-head study in which Foundayo outperformed Novo’s oral semaglutide in lowering blood sugar levels and weight loss in T2D patients.
Prior to the launch of Wegovy tablets, Novo had been boasting an oral semaglutide formulation for type 2 diabetes called Rybelsus since 2019. In early May, Novo, recognizing the excellent brand recognition of its diabetes incretin injection Ozempic, relaunched its oral T2D product in a slightly adjusted formulation, now sold as Ozempic tablets.
Lilly’s head-to-head battle used oral semaglutide even before the brand change, with Novo’s oral doses of 7mg and 14mg and Foundayo’s oral doses of 9mg and 17.2mg being contested.
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Breaking down the Achieve-3 numbers, Foundayo lowered patients’ A1C by an average of 1.9% and 2.2% at 52 weeks for the 9mg and 17.2mg doses, compared to 1.1% for oral semaglutide 7mg and 1.4% for oral semaglutide 14mg. Lilly said in a release on Monday that when comparing the highest doses, Foundayo resulted in a relative reduction of 57.1%.
Additionally, 37.1% of patients receiving the highest dose of Foundayo were able to achieve an A1C below 5.7%, which is within the euglycemic threshold, compared to only 12.5% of patients receiving the highest dose of oral semaglutide tested.
In terms of weight loss, Lilly’s oral GLP-1 was once again superior to Novo’s at all doses. Patients were able to lose an average of about 9.2% (approximately 19.7 pounds) with 17.2 mg of foundayo compared to an average loss of 5.3% (11 pounds) with 14 mg of oral semaglutide.
Lilly’s data utilized efficacy estimates. This means that the data reflects the results if all patients properly adhered to the treatment plan. Persistence and compliance are continuing obstacles for incretin drugs, especially in the obese setting where high doses often cause unpleasant gastrointestinal side effects.
The head-to-head results are “substantive,” said Thomas Seck, Lilly senior vice president of cardiometabolic health product development, during a fireside chat at the scientific session.
Regarding safety, Seck noted that Foundayo’s profile is “consistent” with the broader GLP-1 class. Overall, he emphasized that he believes Achieve-3 will serve as a “very robust study” that will provide information to help healthcare professionals make treatment decisions when faced with choosing between several promising anti-diabetic drugs.
While oral semaglutide is arguably Foundayo’s biggest rival in the GLP-1 class, Lilly also used the ADA Scientific Sessions in New Orleans to demonstrate the drug’s potential to improve on older diabetes treatments in AstraZeneca’s SGLT2 blockbuster Faxiga (dapagliflozin).
AZ’s drug, also a pill taken by mouth, first won approval from the FDA for type 2 diabetes in 2014, and was later expanded with a lasso to reduce the risk of heart failure hospitalizations in those same patients. Additionally, the drug has received approval for certain uses, including for heart failure and kidney disease.
In Lilly’s Achieve-2 trial, Foundayo helped lower A1C by an average of 1.7% from baseline of 8.1%. Meanwhile, Farxiga’s decline at week 40 of the study was 0.8%. Meanwhile, Lilly said up to 68.6% of patients given the highest dose of Foundayo, 17.2mg, achieved an A1C of 6.5% or below, the level recommended for more thorough blood sugar control. In contrast, just under 22% of patients receiving Farxiga met the A1C benchmark.
Mr. Foundayo also outperformed Mr. Fasiga in terms of weight loss in the trial, which enrolled 962 participants with type 2 diabetes and poor blood sugar control with metformin.
Lilly concluded with the program’s third exam, Achieve-5. The trial compared insulin glargine titrated over 40 weeks to a placebo and similarly favored Foundayo when it came to lowering blood sugar levels and weight loss.
Lilly announced the Achieve-4 results in April, just days after Foundayo was launched as an oral option to treat obesity. This Phase 3 study demonstrated that Foundayo was non-inferior to insulin glargine in adults with type 2 diabetes who are obese or overweight and at increased cardiovascular risk. Demonstrating the superiority of insulin glargine in improving blood sugar levels and reducing weight, the risk of major major cardiovascular events (MACE) was 16% lower in the Foundayo cohort compared to the insulin group.
At the time, Lilly said it would use this data package to submit a potential U.S. diabetes application to Foundayo by the end of the second quarter. Lilly said it aims to use one of the FDA Commissioner’s national priority review vouchers for the application, adding that Foundayo’s review could be completed in just a few months.
