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# Lilly’s Oral Diabetes Drug Outperforms Rival in Head-to-Head Trial
- URL: https://www.fdaweb.com/lillys-oral-diabetes-drug-outperforms-rival-in-head-to-head-trial/
- Published: 2025-09-17T12:00:00.000Z
- Updated: 2026-09-14T15:21:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159882

Eli Lilly says its investigational oral diabetes drug orforglipron achieved stronger blood sugar and weight loss results than Novo Nordisk’s oral semaglutide in a large late-stage head-to-head study. In the 52-week ACHIEVE-3 Phase 3 trial, orforglipron cut average A1C levels — a key measure of blood sugar control — by as much as 2.2 percentage points, compared with a 1.4-point reduction for the highest dose of oral semaglutide, the company says. Participants on the highest dose of orforglipron also lost an average of 19.7 pounds (9.2% of body weight), nearly double the 11 pounds (5.3%) shed by those on semaglutide, it adds.

Lilly says that beyond blood sugar and weight loss, orforglipron also demonstrated improvements in cardiovascular risk factors such as cholesterol, blood pressure and triglycerides. It adds that the safety profile of orforglipron was consistent with earlier studies. Gastrointestinal side effects were the most common and typically mild to moderate, and discontinuation rates due to side effects were slightly higher than with semaglutide (about 9% vs. 5%).

Lilly plans to present full results from the trial at a future medical meeting and submit orforglipron for regulatory approval next year.

Orforglipron is part of Lilly’s broader ACHIEVE clinical program, which is also evaluating it for weight management, obstructive sleep apnea, and hypertension in adults with obesity.