Eli Lilly (LLY, Financial) shares surged around 14% in premarket trading Thursday after the company reported positive Phase 3 trial results for orforglipron, its once-daily oral GLP-1 drug for type 2 diabetes.
In its ACHIEVE-1 trial, the drug met its primary goal of reducing A1C—a key diabetes marker—by 1.3% to 1.6% across three dose levels from a baseline of 8.0%. The placebo group, by comparison, saw just a 0.1% reduction. Patients on the highest dose also lost an average of 16 pounds, or 7.9% of their body weight, without reaching a plateau by the 40-week mark.
Eli Lilly said the pill could be a scalable option for global use, pending regulatory approval. CEO David Ricks noted that the convenience of a daily oral medication may set it apart from injectables currently dominating the market.
Market reactions were swift: Novo Nordisk (NVO, Financial), Lilly's main GLP-1 competitor, dropped roughly 5%. Viking Therapeutics (VKTX, Financial) and Amgen (AMGN, Financial) also traded lower, while Structure Therapeutics (GPCR, Financial) rose about 8%. Hims & Hers Health declined 7%.
Mild to moderate gastrointestinal issues were the most common side effects, with an 8% dropout rate at the highest dose. Eli Lilly plans to file for regulatory approval in diabetes by 2026 and in obesity by late 2025.
