Eli Lilly and Company (NYSE: LLY) reported that its oral diabetes drug Foundayo demonstrated superior blood sugar control and weight loss compared to oral semaglutide in a head-to-head clinical trial, according to results presented at the American Diabetes Association's annual meeting.

In the 52-week ACHIEVE-3 trial involving 1,698 participants, Foundayo's highest dose of 17.2 mg reduced A1C levels by 2.2% compared to 1.4% with oral semaglutide's 14 mg dose, representing a 57.1% greater relative reduction. Participants taking Foundayo also lost an average of 19.7 pounds versus 11.0 pounds with oral semaglutide, a 73.6% greater relative weight loss.

The trial marked the first direct comparison between two oral GLP-1 receptor agonists for type 2 diabetes treatment. More patients taking Foundayo's highest dose achieved normal blood sugar levels, with 37.1% reaching an A1C below 5.7% compared to 12.5% with oral semaglutide.

Two additional Phase 3 trials, ACHIEVE-2 and ACHIEVE-5, showed Foundayo met primary endpoints when compared to dapagliflozin and placebo respectively. In ACHIEVE-2, up to 68.6% of patients taking Foundayo achieved an A1C of 6.5% or lower compared to 21.6% with dapagliflozin.

Treatment discontinuation rates due to adverse events were higher with Foundayo, ranging from 8.7% to 12.4% across the three trials compared to 1.2% to 4.9% with comparator drugs. The most common side effects were gastrointestinal, including nausea, diarrhea and vomiting.

Lilly plans to submit Foundayo for type 2 diabetes treatment to the U.S. Food and Drug Administration by the end of the second quarter. The drug is currently approved for weight management in adults with obesity.