Novo Nordisk’s Amycretin Demonstrates Superior Weight Loss Versus Placebo

Amycretin has shown statistically significant weight loss and reductions in HbA1c in patients with inadequately controlled type 2 diabetes (T2D), according to results from a phase 2 clinical trial.1

Announced by parent company Novo Nordisk on November 25, 2025, these positive headline results highlight the efficacy of the investigative unimolecular GLP-1 and amylin receptor agonist. The treatment is intended for once-weekly subcutaneous administration or once-daily oral administration.1

“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,” Martin Holst Lange, chief scientific officer and executive vice president of research and development at Novo Nordisk, said in a statement.1

The phase 2 trial was an interventional, multinational, multi-center, randomized, double-blind, placebo-controlled, parallel, dose-finding study investigating the safety, efficacy, and pharmacokinetic properties of amycretin. Patients in the trial were required to have T2D poorly controlled (HbA1c 7-10%) and be on a stable dose of metformin with or without an SGLT2 inhibitor.1

A total of 448 patients were included in the trial; of these, roughly 40% were using an SGLT2 inhibitor prior to the trial. Patients were randomly assigned among 6 subcutaneous doses from 0.4 to 40 mg weekly and 3 daily oral doses of 6 mg, 25 mg, and 50 mg, or placebo. Treatment duration was 36 weeks.1

If all patients adhered to treatment from a mean baseline HbA1c of 7.8%, those taking once-weekly subcutaneous amycretin achieved dose-dependent reductions in HbA1c of ≤-1.8% by week 36. The proportion of people achieving HbA1c <7% and ≤6.5% were up to 89.1% and 76.2%, respectively. Those treated with once-daily oral amycretin achieved dose-dependent improvements up to ≤-1.5% by week 36. The proportion of patients achieving an HbA1c <7% and ≤6.5% with oral amycretin was 77.6% and 62.6%, respectively.1

The placebo arm achieved HbA1c improvement of -0.2% and -0.4% with subcutaneous and oral amycretin, respectively. Additionally, estimated HbA1c improvements were statistically significant versus placebo across the board.1

Additionally, patients saw statistically significant weight loss ≤-14.5% compared to -2.6% in those receiving placebo. People treated with the highest possible dose of subcutaneous amycretin were on the final maintenance dose for 4 weeks. Additionally, from a mean baseline body weight of 101.1 kg, people receiving oral amycretin also achieved substantial weight loss ≤-10.1% versus -2.5% in the placebo arm. No weight loss plateau was observed at week 36.1

“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 program across multiple indications in 2026,” Lange said.1

Novo Nordisk has also announced its plan to initiate a phase 3 development program for adults with T2D in 2026.1

References

1. Novo Nordisk. Novo Nordisk phase 2 trial with amycretin reports significant weight loss and HbA1c reduction in type 2 diabetes. November 25, 2025. Accessed November 25, 2025. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916463