Novel Obesity Drug Induces Weight Loss Up to 22% with No Safety Concerns in clinical trial

In a phase 1b/2a trial subcutaneous amycretin demonstrated a safety profile similar to other incretin-based drugs . Adults with obesity experienced greater weight loss with 1.25 mg, 5 mg, and 20 mg amycretin compared to placebo.A novel GLP-1 and amylin receptor agonist, amycretin, showed a safety profile comparable to other incretin-based therapies while delivering substantial weight loss in adults with obesity. These findings come from top-line results of a phase 1b/2a clinical trial.

Amycretin (Novo Nordisk) is a once-weekly subcutaneous drug in development for treating overweight individuals, obesity, and type 2 diabetes. The study enrolled 125 adults with overweight or obesity in a five-part trial, with treatment-emergent adverse events as the primary endpoint.

A three-part proof-of-concept study compared amycretin's weight loss effects against a placebo, demonstrating its potential as a promising treatment option for obesity management.

The trial was a combined single ascending dose, multiple ascending dose and dose-response trial investigating three different maintenance doses with a total treatment duration of up to 36 weeks.

The primary endpoint was treatment emergent adverse events. The safety profile of amycretin was consistent with incretin-based therapies. The most common adverse events with amycretin were gastrointestinal and the vast majority were mild to moderate in severity.

When evaluating the effects of treatment if all people adhered to treatment1 from a mean baseline body weight of 92.7 kg, people treated with amycretin achieved an estimated body weight loss of 9.7% on 1.25mg (20 weeks), 16.2% on 5mg (28 weeks) and 22.0% on 20mg (36 weeks). People treated with placebo experienced an estimated 1.9%, 2.3% and 2.0% body weight gain, respectively.

“We are very encouraged by the subcutaneous phase 1b/2a results for amycretin in people living with overweight or obesity,” said Martin Lange, executive vice president for Development at Novo Nordisk. “The results seen in the trial support the weight lowering potential of this novel unimolecular GLP-1 and amylin receptor agonist, amycretin, that we have previously seen with the oral formulation.”

Based on the results, Novo Nordisk is now planning further clinical development of amycretin in adults with overweight or obesity.

About amycretin

Amycretin is a unimolecular long-acting GLP-1 and amylin receptor agonist under development by Novo Nordisk, to provide an efficacious and convenient treatment for adults with overweight or obesity and as a treatment for adults with type 2 diabetes. Amycretin is developed for oral and subcutaneous administration.

About the Phase 1b/2a subcutaneous amycretin trial

The trial was a randomised, placebo-controlled and double-blinded study assessing the safety, tolerability, pharmacokinetics, and proof-of-concept after subcutaneous administration of amycretin in people with overweight or obesity. The trial was conducted in 5 parts: A single ascending dose (Part A) for determination of pharmacokinetics and starting dose for the first multiple dose cohort in which the safety and tolerability were explored using dose escalation until 36 weeks of total treatment duration (Part B). Lastly, in the proof-of-concept part, body weight loss was explored for up to 36 weeks of dosing by escalating to dose levels of 1.25 mg, 5 mg, and 20 mg, respectively, dosed for 12 weeks (Part E, D and C).