Eli Lilly (LLY) shares surged 11.99% in pre-market trading on Thursday following the announcement of positive topline Phase 3 results for its experimental oral diabetes and weight loss pill, orforglipron. The company reported that the drug met its primary endpoint in the ACHIEVE-1 trial, demonstrating statistically significant efficacy results and a safety profile consistent with injectable GLP-1 medicines.

Orforglipron, the first oral small molecule GLP-1 receptor agonist to successfully complete a Phase 3 trial, showed impressive results in treating type 2 diabetes and promoting weight loss. The drug lowered A1C levels by an average of 1.3% to 1.6% from a baseline of 8.0% at 40 weeks. In a key secondary endpoint, participants taking the highest dose of orforglipron lost an average of 16.0 lbs (7.9%) of their body weight.

The positive results have significant implications for Eli Lilly's position in the competitive diabetes and obesity treatment market. The company plans to submit orforglipron for weight management to global regulatory agencies by the end of this year, with a submission for the treatment of type 2 diabetes anticipated in 2026. Lilly's CEO, David A. Ricks, expressed confidence in the company's ability to launch orforglipron worldwide without supply constraints if approved, potentially addressing the needs of millions of people with chronic diseases like type 2 diabetes.