Novo Nordisk Plans Phase 3 Trials for Next-Generation Obesity Drug Amycretin

Novo Nordisk will advance both subcutaneous and oral versions of amycretin, a next-generation GLP-1 and amylin receptor co-agonist, into Phase 3 clinical trials targeting adults with overweight or obesity.

The Phase 3 trials are scheduled to begin in the first quarter of 2026, following a positive review and feedback from regulatory authorities after Phase 2 studies125.

In Phase Ib/IIa studies, amycretin showed up to 22% weight loss after 36 weeks—substantially better than Novo's current blockbuster therapy Wegovy (semaglutide), which achieved 14% weight loss in a comparable period1.

The most common side effects reported were gastrointestinal issues, generally mild to moderate in severity1.

If Phase 3 trials are successful, amycretin could receive U.S. approval for weight management in late 2030, and European approval in early 20311.

Amycretin demonstrates the ongoing innovation in Novo Nordisk’s cardiometabolic pipeline and will be discussed among new data at major medical meetings, including the upcoming American Diabetes Association (ADA) 2025 conference3.

Sources:

1. https://www.clinicaltrialsarena.com/news/novo-nordisk-obesity-drug-phase-iii-trial-advance/

2. https://www.nasdaq.com/articles/novo-nordisk-start-phase-3-trial-amycretin-weight-loss-early-2026

3. https://www.prnewswire.com/news-releases/novo-nordisk-to-present-array-of-new-portfolio-data-including-studies-with-semaglutide-and-cagrisema-expanding-evidence-in-obesity-and-diabetes-care-at-ada-2025-302477630.html

5. https://www.pharmajournalist.com/novo-nordisk-advances-amycretin-for-weight-loss-to-phase-3-trials/