Novo Nordisk advances Amycretin to Phase 3 trials for weight management

DENMARK—Danish pharmaceutical company Novo Nordisk has announced plans to advance its drug candidate, amycretin, into phase 3 clinical trials for weight management.

This decision follows positive feedback from regulatory authorities after the completion of phase 2 studies for both subcutaneous and oral forms of amycretin.

Martin Lange, Executive Vice President for Development at Novo Nordisk, expressed enthusiasm about the regulatory approval to proceed.

He described this milestone as an important step forward for the company and highlighted their excitement about the potential of the amycretin molecule.

Lange also indicated that more details about the design of the upcoming phase 3 program would be shared in due course.

Novo Nordisk aims to begin the phase 3 development program for amycretin in the first quarter of 2026, targeting adults who are overweight or living with obesity.

Amycretin is a long-acting, unimolecular drug that acts as both a GLP-1 and amylin receptor agonist.

It is being developed to offer an effective and convenient treatment option for adults with overweight or obesity, as well as for those with type 2 diabetes.

Notably, amycretin is being formulated for both subcutaneous injection and oral administration, providing flexibility in how patients can receive the medication.

Results from earlier clinical trials supported the decision to move forward.

The phase 1 trial for oral amycretin tested single and multiple ascending doses—up to twice daily doses of 50 mg—in individuals with overweight or obesity, with treatment lasting for up to 12 weeks.

Meanwhile, the phase 1b/2a trial for subcutaneous amycretin assessed its safety, tolerability, pharmacokinetics, and efficacy when administered once weekly.

This combined trial encompassed single-ascending dose, multiple-ascending dose, and dose-response assessments across three distinct maintenance doses, with treatment durations extending up to 36 weeks.

By advancing amycretin into phase 3 trials, Novo Nordisk is taking a significant step toward potentially expanding treatment options for weight management and type 2 diabetes.

The company’s focus on both injectable and oral forms of the drug demonstrates a commitment to enhancing patient convenience and adherence, which are critical factors in managing chronic conditions such as obesity and diabetes.

The upcoming phase 3 trials will be crucial in confirming amycretin’s efficacy and safety on a larger scale before it can be considered for regulatory approval and wider use.

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