Danish pharmaceutical giant Novo Nordisk has unveiled plans to initiate Phase 3 clinical trials for its innovative obesity treatment amycretin, marking a significant expansion of its weight-loss medication portfolio. The company announced on Thursday that the trials are scheduled to commence in early 2026, encompassing both injectable and oral formulations of the drug.
The development comes at a crucial time for Novo Nordisk, which has experienced significant market challenges, including a more than 40% decline in share value over the past year and the recent announcement of CEO Lars Fruergaard Jørgensen’s departure. The company’s position in the obesity drug market has been challenged by competitor Eli Lilly’s Zepbound, which has gained substantial market share from Novo’s established treatment, Wegovy.
Initial Phase 2 trial results for amycretin have shown promising outcomes, with participants experiencing up to 22% body weight reduction over a 36-week period. These results surpass the weight loss achieved with both Wegovy and Lilly’s Zepbound. The drug’s mechanism of action targets both GLP-1 and amylin, the latter being a metabolic hormone that has attracted increasing attention from pharmaceutical companies.
Amycretin’s development represents a different approach from Novo’s other dual-action treatment, cagrisema, which recently disappointed in Phase 3 trials. While cagrisema combines two separate medicines in a dual-chamber injector pen, amycretin is engineered as a single molecule with potentially more potent amylin-targeting capabilities, according to Cantor Fitzgerald analyst Prakhar Agrawal.
The announcement follows recent industry developments highlighting growing interest in amylin-based therapies. Earlier this week, biotechnology company Metsera saw its shares surge following positive Phase 1 results for its own amylin-targeting compound. Major pharmaceutical companies have also made significant investments in this space, with Roche committing over $1 billion to acquire a Zealand Pharma-developed therapy, and AbbVie securing rights to a
Gubra-developed compound in a deal potentially worth nearly $2 billion.
Novo Nordisk continues to advance other obesity treatments, including an oral version of Wegovy currently under FDA review and a higher-dose injectable formulation in Phase 3 testing. The company is also pursuing additional studies of cagrisema to optimize its dosing regimen for enhanced weight loss results before its planned regulatory submission in 2026.
Meanwhile, competition in the obesity drug market remains intense, with Eli Lilly advancing two new medications through late-stage development. These include a GLP-1 pill that has already demonstrated success in Phase 3 diabetes trials and an amylin-targeting compound in Phase 2 studies.
The expanding focus on amylin-based therapies reflects a broader industry trend toward developing more effective obesity treatments. With multiple pharmaceutical companies investing heavily in this area, the competition to develop next-generation weight loss medications continues to intensify. Success in this field could be particularly significant for Novo Nordisk as it seeks to maintain its position as a leader in obesity treatment while facing increased market pressure and the need to diversify its product pipeline beyond its current offerings.
The timing of amycretin’s Phase 3 trials positions Novo Nordisk to potentially introduce a new competitive entry in the rapidly evolving obesity drug market, where demand for effective treatments continues to grow despite existing options.
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