Novo Nordisk's Amycretin Shows Promising Phase 2 Results in Type 2 Diabetes, Advances to Phase 3 Trials
核心洞察
Novo Nordisk's amycretin demonstrated significant weight loss of up to 14.5% and HbA1c reductions of up to 1.8% in a phase 2 trial of 448 people with type 2 diabetes (搜索).
The dual GLP-1 and amylin receptor (搜索) agonist showed efficacy in both once-weekly subcutaneous and once-daily oral formulations with a well-tolerated safety profile.
Based on these positive results, Novo Nordisk plans to initiate phase 3 development programs for amycretin in type 2 diabetes (搜索) in 2026.
Novo Nordisk announced positive headline results from a phase 2 clinical trial evaluating amycretin in people with type 2 diabetes (搜索), marking the first time this dual GLP-1 and amylin receptor (搜索) agonist has been tested in this patient population. The results showed significant improvements in both weight loss and glycemic control, prompting the company to advance the drug into phase 3 trials next year.
Trial Design and Patient Population
The phase 2 trial was a multinational, multi-center, randomized, double-blind, placebo-controlled study that enrolled 448 people with type 2 diabetes (搜索) inadequately controlled on metformin with or without an SGLT2 inhibitor. Approximately 40% of participants were using an SGLT2 inhibitor before initiating the trial, and close to two-thirds were male across both administration routes.
The study investigated nine active treatment arms, testing six subcutaneous doses of amycretin ranging from 0.4 mg to 40 mg administered weekly, and three daily oral doses of 6 mg, 25 mg, and 50 mg. The total treatment duration extended up to 36 weeks.
Significant Glycemic Control Improvements
From a mean baseline HbA1c of 7.8%, once-weekly subcutaneous amycretin achieved dose-dependent reductions in HbA1c of up to 1.8% by week 36. The proportion of people achieving HbA1c levels below 7% reached 89.1%, while 76.2% achieved levels at or below 6.5%.
The oral formulation also demonstrated substantial efficacy. From a mean baseline HbA1c of 8.0%, people treated with once-daily oral amycretin achieved dose-dependent improvements in HbA1c of up to 1.5% by week 36. Among oral amycretin recipients, 77.6% achieved HbA1c levels below 7%, and 62.6% reached levels at or below 6.5%.
By comparison, people treated with placebo achieved minimal HbA1c improvements of only 0.2% and 0.4% with subcutaneous and oral formulations, respectively. All estimated improvements in HbA1c were statistically significant versus placebo, confirming the primary endpoints of the trial.
Substantial Weight Loss Benefits
The trial demonstrated impressive weight loss results across both formulations. From a mean baseline body weight of 99.2 kg, subcutaneous amycretin achieved statistically significant weight loss of up to 14.5% compared to 2.6% in people treated with placebo. People treated with the highest dose of subcutaneous amycretin were on the final maintenance dose for a duration of 4 weeks.
Similarly, from a mean baseline body weight of 101.1 kg, people treated with oral amycretin achieved statistically significant weight loss of up to 10.1% compared to 2.5% in the placebo group. Notably, for the higher doses of amycretin, regardless of administration route, no weight loss plateau was observed at week 36.
Safety and Tolerability Profile
Both subcutaneous and oral amycretin appeared to have a safe and well-tolerated profile, consistent with other incretin and amylin-based therapies. The most common adverse events with amycretin were gastrointestinal, and the vast majority were mild to moderate in severity.
Clinical Significance and Future Development
"We are very encouraged by the phase 2 data with amycretin in people with type 2 diabetes (搜索) - the first time amycretin has been evaluated in this population," said Martin Holst Lange, chief scientific officer and executive vice president of Research and Development at Novo Nordisk. "The data further validate the potential best-in-class profile of amycretin."
Lange emphasized that "amycretin is built on the complementary biology of GLP-1 and amylin, and we are looking forward to bringing amycretin into an extensive phase 3 development programme across multiple indications in 2026."
Based on these results, Novo Nordisk is planning to initiate a phase 3 development programme with amycretin for adults with type 2 diabetes (搜索) in 2026. The company had previously announced plans to advance both formulations directly into phase 3 for obesity (搜索) based on earlier trial results and regulatory feedback.
Market Impact
Following the announcement of the amycretin data, shares in Novo Nordisk rose nearly 4%, reflecting investor confidence in the programme and its potential to maintain the company's position in the increasingly competitive incretin market. This positive development comes after recent disappointment with the company's oral semaglutide trials in Alzheimer's disease (搜索), which failed to show cognitive benefits.