Lilly’s Orforglipron Delivers Phase III Weight Maintenance Success, NDA Filed

Eli Lilly’s oral GLP-1 receptor agonist orforglipron has demonstrated strong weight-maintenance efficacy in a Phase III obesity study, supporting the company’s decision to submit a new drug application to the US Food and Drug Administration. In the 52-week ATTAIN-MAINTAIN trial, orforglipron met its primary endpoint by significantly maintaining weight loss compared with placebo when combined with diet and exercise.

The study enrolled patients who had previously completed long-term treatment with injectable GLP-1 therapies, including Lilly’s Zepbound or Novo Nordisk’s Wegovy. Participants transitioning to orforglipron experienced limited weight regain over one year, highlighting its potential as a convenient oral maintenance option. The drug’s safety profile was consistent with earlier studies, with mostly mild-to-moderate gastrointestinal adverse events and low discontinuation rates.

Lilly is investing heavily in manufacturing capacity ahead of a potential 2026 launch. Analysts forecast orforglipron to become a mega-blockbuster, reflecting intensifying competition in the rapidly expanding obesity treatment market.

24-12-2025