Eli Lilly (LLY, Financial) rose about 14% in premarket trade Thursday after reporting positive top-line results from a late-stage trial of its experimental oral GLP-1 drug, orforglipron, in adults with type 2 diabetes.
In the Phase 3 ACHIEVE-1 study, the once-daily pill met its main goal, showing a reduction in A1C levels, a key diabetes marker, of 1.3% to 1.6% across multiple doses. Patients on placebo saw a drop of just 0.1%.
The 40-week trial, which enrolled 559 patients, also showed average weight loss of 7.9% (about 16 pounds) at the highest 36 mg dose, though participants had not reached a weight plateau at analysis. Using a broader treatment model that includes all randomized participants, weight loss peaked at 7.6%, which the company said was statistically significant.
Gastrointestinal side effects were the most frequent, generally mild to moderate, but 8% of patients on the 36 mg dose discontinued due to adverse events, versus 1% on placebo.
Lilly plans to submit marketing applications for orforglipron for type 2 diabetes and obesity starting in late 2025.
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