Novo Nordisk Advances Next-Generation Obesity Treatment Amycretin to Phase 3 Trials

Danish pharmaceutical giant Novo Nordisk has announced plans to move its investigational obesity treatment, amycretin, into phase 3 clinical trials. This development marks a significant step forward in the company's efforts to maintain its leadership position in the increasingly competitive weight loss drug market.

Amycretin: A Dual-Acting Approach to Weight Loss

Amycretin, a novel GLP-1 and amylin receptor agonist, has shown promising results in earlier studies. In a phase 1b/2a trial, participants receiving weekly amycretin injections experienced an average weight loss of 22% over 36 weeks. This efficacy places amycretin in a potentially competitive position against other leading weight loss medications.

Novo Nordisk is pursuing both subcutaneous and oral formulations of amycretin, broadening its potential application and market reach. The oral version demonstrated a 13.1% weight reduction in participants who took the therapy daily for 12 weeks during a phase 1 trial.

Phase 3 Program Details and Timeline

The company's decision to advance amycretin to late-stage trials follows positive feedback from regulatory authorities after end-of-phase 2 interactions. The phase 3 program, set to begin in the first quarter of 2026, will enroll adults with overweight or obesity.

While specific details of the trial design have not been disclosed, the program is expected to further evaluate the efficacy and safety profile of amycretin. Previous data suggest a safety profile consistent with other incretin therapies, with gastrointestinal issues being the most common adverse events.

Competitive Landscape and Strategic Implications

Novo Nordisk's advancement of amycretin comes at a crucial time for the company. In December 2024, Eli Lilly's Zepbound outperformed Novo's current flagship product, Wegovy, in a head-to-head weight loss trial. This setback, coupled with the disappointing performance of another next-generation candidate, CagriSema, has intensified Novo Nordisk's search for more effective obesity treatments.

The company has been actively expanding its obesity pipeline through various licensing deals with companies such as United Laboratories, Lexicon Pharmaceuticals, Septerna, and Deep Apple Therapeutics. These strategic moves, combined with the progression of amycretin, underscore Novo Nordisk's commitment to maintaining its position at the forefront of obesity treatment innovation.