Data sets up phase 3 trials for Novo's amycretin in diabetes

Novo Nordisk has decided to move its amycretin into pivotal trials in type 2 diabetes after a phase 2 readout, having already started preparing phase 3 studies of the dual GLP-1 and amylin agonist as a weight-loss therapy.

The trial of once-weekly injectable and once-daily oral formulations of amycretin showed significant improvements in weight loss and improved blood glucose control compared to placebo in the study, which marks the first time that the drug has been evaluated in a diabetic population.

Novo Nordisk said it will now move ahead with a phase 3 programme for both versions of the drug in adults with type 2 diabetes next year. In June, the company said it would advance both formulations directly into phase 3 for obesity based on phase 1b/2a trial results and feedback from regulatory authorities.

The latest study tested six subcutaneous doses of amycretin, from 0.4 mg to 40 mg, and three oral doses (6 mg, 25 mg and 50 mg) with a total treatment duration of up to 36 weeks.

The results showed weight loss of up to 14.5% of total body weight for the subcutaneous injection, compared to 2.6% in the placebo group, while for the oral dosing, weight loss was up to 10.1% and 2.5%, respectively.

Meanwhile, from an average baseline haemoglobin A1c (HbA1c) level of 7.8% – indicating blood sugar is significantly elevated – there were reductions of up to 1.8% by the end of follow-up for the subcutaneous version. In the oral cohort, levels started at 8.0% and fell by up to 1.5%.

Novo Nordisk also said that both formulations of amycretin appeared to be safe and well-tolerated in the study, with the most common adverse events being gastrointestinal, in common with most incretin-based therapies.

"We are very encouraged by the phase 2 data with amycretin in people with type 2 diabetes," said Martin Holst Lange, Novo Nordisk's chief scientific officer and head of R&D.

"The data further validate the potential best-in-class profile of amycretin…and we are looking forward to bringing amycretin into an extensive phase 3 development programme across multiple indications in 2026."

The positive result for amycretin comes after the disappointment of the evoke and evoke+ trials earlier this week, which showed that Novo Nordisk's oral formulation of GLP-1 agonist semaglutide was unable to slow down the cognitive decline in patients with Alzheimer's disease.

Shares in Novo Nordisk were up nearly 4% after the amycretin data was announced, likely something of a recovery from the Alzheimer's disappointment but also reflecting the importance attached to the programme by investors to the company's efforts to maintain its position in the increasingly competitive incretin market.