Overview
- Eli Lilly submitted a new drug application on December 18 seeking U.S. approval of orforglipron for obesity.
- In the 52-week ATTAIN-MAINTAIN phase 3 study, participants switching from Wegovy gained about 0.9 kg (≈2 lb) and from Zepbound about 5 kg (≈11 lb), preserving roughly 80–95% of prior weight loss and outperforming placebo.
- Safety findings mirrored the GLP-1 class, with mostly mild-to-moderate gastrointestinal events and fewer than 8% discontinuing due to side effects.
- Orforglipron is a once-daily oral GLP-1 that can be taken without the fasting or timing restrictions associated with oral semaglutide.
- Industry reports indicate an FDA ruling could come in early 2026 as Novo Nordisk’s oral Wegovy is also under review and both companies hold priority vouchers.