Eli Lilly's Foundayo Shows Promising Results in Type 2 Diabetes Trials
Lilly's oral GLP-1 Foundayo (orforglipron) delivered superior A1C control and weight loss in three pivotal type 2 diabetes trials
Image: Benzinga
Eli Lilly's oral GLP-1 medication, Foundayo (orforglipron), demonstrated superior A1C reduction and weight loss in three Phase 3 trials for type 2 diabetes. The company plans to submit Foundayo for FDA approval by mid-2026, highlighting its potential as a first-line therapy.
- 01In the ACHIEVE-3 trial, Foundayo reduced A1C by 2.2% at the highest dose, compared to 1.4% with oral semaglutide, marking a 57.1% greater reduction.
- 02Foundayo achieved a weight loss of 19.7 lbs (9.2%) at the 17.2 mg dose, compared to 11.0 lbs (5.3%) with oral semaglutide.
- 03Up to 68.6% of participants in ACHIEVE-2 reached an A1C goal of ≤6.5% with Foundayo, compared to 21.6% with dapagliflozin.
- 04The trials demonstrated consistent safety profiles, with gastrointestinal issues being the most common side effects.
- 05Lilly plans to submit Foundayo for FDA approval by the end of the second quarter of 2026.
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Eli Lilly and Company announced positive results from three pivotal Phase 3 trials—ACHIEVE-2, ACHIEVE-3, and ACHIEVE-5—evaluating Foundayo (orforglipron), an oral GLP-1 receptor agonist for type 2 diabetes. In the ACHIEVE-3 trial, Foundayo showed a 2.2% reduction in A1C at the highest dose, outperforming oral semaglutide, which achieved a 1.4% reduction. Participants taking Foundayo also experienced significant weight loss, averaging 19.7 lbs compared to 11.0 lbs with semaglutide. The trials indicated that up to 68.6% of patients reached an A1C goal of ≤6.5% with Foundayo, significantly higher than the 21.6% achieved with dapagliflozin in ACHIEVE-2. Safety profiles were consistent with previous studies, primarily showing gastrointestinal side effects. Based on these findings, Lilly plans to submit Foundayo for regulatory approval to the U.S. Food and Drug Administration by mid-2026, positioning it as a potential first-line therapy for type 2 diabetes.
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Foundayo's approval could provide a new oral treatment option for millions of adults with type 2 diabetes, potentially improving management of the condition.
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