Eli Lilly disclosed that its experimental oral GLP‑1, orforglipron, achieved a 2.2% reduction in A1C at the 36‑mg dose in a head‑to‑head Phase 3 trial against Novo Nordisk’s oral semaglutide. The same dose also produced an average weight loss of 19.7 lbs, compared with 11.0 lbs for semaglutide.
The trial, known as ACHIEVE‑3, enrolled patients with type 2 diabetes who were already on basal insulin or metformin. The 36‑mg dose of orforglipron outperformed the 14‑mg dose of semaglutide in both glycemic control and weight reduction, underscoring the drug’s potential to become a competitive oral alternative to injectable GLP‑1 therapies.
Lilly has already submitted orforglipron for regulatory review in more than 40 countries. The U.S. Food and Drug Administration’s target action date is April 10, 2026, with a potential approval for obesity in the second quarter of 2026 and a later submission for type 2 diabetes. The company has built a substantial pre‑launch inventory, reflecting confidence in a timely regulatory decision.
The positive trial data come on the heels of Lilly’s Q4 2025 earnings, in which the company reported revenue of $19.3 billion—up 43% year‑over‑year—and a non‑GAAP earnings per share of $7.54. Management highlighted the strong performance of its cardiometabolic portfolio, noting that products such as Mounjaro and Zepbound continue to drive revenue growth.
Executive commentary emphasized the strategic importance of orforglipron. Kenneth Custer, Ph.D., executive vice president and president of Lilly Cardiometabolic Health, said the drug’s oral formulation and superior efficacy could broaden the company’s market share in both diabetes and obesity. Chair and CEO David A. Ricks noted that 2025 was a pivotal year for product submissions and expanded access to obesity medicines, positioning Lilly for continued growth.
Analysts have expressed optimism about orforglipron’s commercial prospects, citing its head‑to‑head advantage over Novo Nordisk’s oral semaglutide and the growing demand for convenient, effective GLP‑1 therapies. The drug’s higher gastrointestinal side‑effect profile and pulse‑rate increase remain areas of focus for ongoing studies.
With the launch of orforglipron potentially in 2026, Lilly would add a second oral GLP‑1 to its portfolio, reinforcing its leadership in the rapidly expanding diabetes and obesity markets and providing a new revenue stream that could offset competitive pressures from other manufacturers.
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