Novo Nordisk has announced positive headline results from a Phase 2 clinical trial for its investigational drug, amycretin, showcasing its potential to be a next-generation treatment for type 2 diabetes (T2D) by driving significant improvements in both blood sugar control and body weight.
The company revealed that amycretin, a novel unimolecular GLP-1 and amylin receptor agonist, achieved statistically significant weight loss and reductions in HbA1c (a key measure of long-term blood sugar control) in patients with inadequately controlled T2D compared to placebo. The drug is being developed in both a once-weekly subcutaneous injection and a once-daily oral formulation.
Trial Results Detail Impressive Efficacy
The Phase 2 trial was a 36-week, dose-finding study involving 448 patients with T2D, who had baseline HbA1c levels between 7% and 10% and were already taking stable doses of metformin (with or without an SGLT2 inhibitor). The results validated amycretin’s dual-action mechanism across both delivery methods:
- Subcutaneous Formulation (Once-Weekly): Patients receiving once-weekly subcutaneous amycretin achieved dose-dependent reductions in HbA1c of up to ≤-1.8% from a mean baseline of 7.8% by week 36. Crucially, up to 89.1% of participants achieved the therapeutic target of HbA1c below 7%, with 76.2% reaching the more aggressive target of HbA1c ≤6.5%.
- Oral Formulation (Once-Daily): Patients treated with the once-daily oral version of amycretin showed comparable dose-dependent improvements in HbA1c up to ≤-1.5% by the end of the 36-week trial.
While specific percentage weight loss figures from the press release were reserved for the subcutaneous version, the overall data indicated significant weight loss across all effective doses, further solidifying the drug’s position as a promising candidate in the highly competitive GLP-1/anti-obesity market.
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Company Leadership Praises Amycretin’s Profile
The positive outcomes reinforce Novo Nordisk’s robust pipeline in metabolic disease treatment. Martin Holst Lange, chief scientific officer and executive vice president of research and development at Novo Nordisk, expressed strong optimism regarding the findings.
We are very encouraged by the Phase 2 data with amycretin in people with type 2 diabetes the first time amycretin has been evaluated in this population,
The data further validate the potential best-in-class profile of amycretin and its unique mechanism of action as a co-agonist of both the GLP-1 and amylin receptors.
Martin Holst Lange
The dual-receptor agonism of amycretin is designed to combine the proven blood glucose control and weight loss benefits of GLP-1 (like its blockbuster drugs Ozempic and Wegovy) with the appetite suppression and gastric emptying modulation of amylin, potentially offering a more powerful therapeutic option.
Following these successful headline results, Novo Nordisk is expected to accelerate the development of amycretin into Phase 3 trials, positioning it as a key component of the company’s future portfolio in diabetes and obesity care.
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