Novo Nordisk’s amycretin showed no weight-loss plateau over 36 weeks in patients with type 2 diabetes, suggesting its efficacy could become even stronger with longer follow-up, according to analysts at BMO Capital Markets.
A day after its blockbuster GLP-1 semaglutide failed to show significant benefit in treating Alzheimer’s disease, Novo Nordisk redeemed its pipeline with a mid-stage win for next-generation weight-loss drug amycretin.
Data released Tuesday from a Phase II trial of 448 people with type 2 diabetes showed that a daily oral dose of amycretin triggered a 7.6% placebo-adjusted reduction in body weight at 36 weeks, while the drug’s weekly subcutaneous formulation resulted in 11.9% placebo-adjusted weight-loss, according to analysts at BMO Capital Markets. Both versions of amycretin were safe, Novo said in its news release, with most side effects being gastrointestinal in nature and mild to moderate in severity.
Writing to investors on Tuesday morning, BMO analysts said these data paint a “potentially differentiated profile” for amycretin, positioning it as a “competitive” therapy to Eli Lilly’s orforglipron and tirzepatide. “Though not enough to completely change the narrative for Novo,” they continued, these mid-stage findings “mark a step in the right direction for the company.”
“Importantly, no weight loss plateau was observed in either administration route, suggesting the potential for additional weight loss at longer time points,” the analysts added.
Tuesday’s readout also includes data on blood glucose levels, as represented by HbA1c. Patients treated with subcutaneous amycretin saw a 1.8% drop in HbA1c at 36 weeks, while the oral version elicited a 1.5% reduction at the same time point. Both drug formulations elicited dose-dependent improvements in glucose concentrations. In contrast, respective placebo comparators saw a 0.2% and 0.4% decrease in HbA1c.
Despite amycretin’s promising efficacy, BMO nevertheless flagged the “limited tolerability data” in Novo’s release, noting that safety “still remains a key consideration” for the drug, particularly its oral formulation, which according to the analysts had a 37.5% vomiting rate in Phase I. “We will look for additional clarity here in an upcoming full data release,” they said.
Amycretin is a long-acting drug that activates both the GLP-1 and amylin receptors, in turn helping to control blood sugar levels and suppressing appetite. Phase Ib/IIa data in 125 adults who were overweight or have obesity released in June showed 23.9% placebo-adjusted weight-loss for a 20-mg subcutaneous dose.
Buoyed by these findings, Novo at the time said it would push both oral and subcutaneous formulations of amycretin into late-stage development. Study initiation is slated for the first half of next year. The Danish pharma is neck-and-neck with Lilly, which earlier this month announced the advancement of amylin asset eloralintide into Phase III after it elicited around 20% weight-loss in a mid-stage trial.
Amycretin’s mid-stage win comes a day after Novo reported that its flagship obesity drug semaglutide bore no clinical benefit on patients with Alzheimer’s disease. Stifel called this late-stage failure “very definitive.”
