Lilly’s Foundayo Delivers 57% Superior A1C Reduction and 73.6% Greater Weight Loss
LLY•Foundayo 17.2 mg produced a 2.2% A1C reduction and 9.2% weight loss, representing 57.1% and 73.6% greater relative improvements than oral semaglutide 14 mg at 52 weeks. Lilly will submit Foundayo for type 2 diabetes approval by the end of Q2 2026.
1. Phase 3 Efficacy Results
Foundayo 17.2 mg lowered A1C by an average of 2.2% and weight by 9.2% at 52 weeks, outperforming oral semaglutide’s 1.4% A1C reduction and 5.3% weight loss by 57.1% and 73.6% relative margins in the ACHIEVE-3 trial. In ACHIEVE-2 and ACHIEVE-5, up to 68.6% and 69.1% of participants respectively achieved an A1C ≤6.5%, with weight losses up to 15.0 lbs versus controls.
2. Regulatory Submission Plans
Lilly plans to file Foundayo’s New Drug Application with the FDA by the end of the second quarter of 2026, aiming to secure approval as the first small-molecule oral GLP-1 receptor agonist without food or water restrictions. This timeline positions Foundayo for potential market entry in late 2026 or early 2027.
3. Safety and Additional Benefits
Foundayo’s safety profile was consistent across trials, with gastrointestinal events such as nausea and diarrhea most common and discontinuation rates under 13% at highest doses. All studies also showed favorable impacts on cardiovascular risk factors, including reductions in non-HDL cholesterol, systolic blood pressure and triglycerides.
