Lilly to Seek Global Approval for GLP-1 Pill After Obesity and Diabetes Trial Success

Eli Lilly plans to submit global regulatory applications for its first GLP-1 oral weight loss pill, orforglipron, by the end of 2025, including to the FDA in the US13.

The latest Phase 3 trial showed that orforglipron led to an average weight loss of 10.5%-11% in patients with both obesity and type 2 diabetes over 72 weeks, outperforming placebo and closely matching results seen in obesity-only patients134.

Orforglipron also led to significant improvements in blood sugar (A1C) levels, addressing both weight and glycemic control for a difficult-to-treat population125.

Analysts say orforglipron is likely to be the first commercially successful oral GLP-1 therapy for weight loss due to its efficacy, safety, and tolerability2.

Orforglipron is the second GLP-1 weight loss pill to be submitted for approval globally, following rival Novo Nordisk13.

Compared to injectable GLP-1 drugs (e.g., Wegovy, Zepbound), pills like orforglipron offer easier administration but have somewhat lower efficacy; injectables have shown weight loss rates above 20%1.

If approved, Lilly expects orforglipron could be available as a once-daily pill as soon as next year15.

Sources:

1. https://www.emarketer.com/content/eli-lilly-moves-file-approval-of-glp-1-weight-loss-pill

2. https://www.fiercebiotech.com/biotech/lilly-rounds-out-oral-glp-1-approval-bid-ph-3-win-patients-obesity-and-diabetes

3. https://www.biopharmadive.com/news/lilly-glp-1-orforglipron-fda-submission-obesity-diabetes/758608/

4. https://firstwordpharma.com/story/5992059

5. https://abcnews.go.com/GMA/Wellness/eli-lillys-oral-glp-1-pill-people-type/story?id=124963525