Novo Nordisk Completes Promising Phase 1b/2a Study for Amycretin in Overweight and Obesity Treatment

Novo Nordisk has announced encouraging outcomes from its Phase 1b/2a clinical trial investigating amycretin, a novel GLP-1 and amylin receptor agonist developed for weekly subcutaneous use. This investigational therapy is designed to aid individuals struggling with overweight or obesity.

Study Overview

The trial assessed amycretin’s safety, tolerability, pharmacokinetics, and efficacy in promoting weight loss. It involved 125 participants with overweight or obesity and featured a combination of single ascending dose, multiple ascending dose, and dose-response components. Participants received treatment over a period of up to 36 weeks, with three different maintenance doses evaluated: 1.25 mg, 5 mg, and 20 mg.

The primary goal was to monitor treatment-emergent adverse events. The safety profile of amycretin was in line with other incretin-based therapies. Gastrointestinal issues were the most commonly reported side effects, which were mostly mild to moderate in severity.

Weight Loss Results

When examining the treatment’s effectiveness for individuals who adhered to the prescribed regimen:

• 1.25 mg dose (20 weeks): Participants experienced an estimated average weight loss of 9.7% from a baseline of 92.7 kg.

• 5 mg dose (28 weeks): Weight loss increased to 16.2%.

• 20 mg dose (36 weeks): The highest dose resulted in a significant weight reduction of 22.0%.

In comparison, individuals in the placebo group experienced slight weight gains of 1.9%, 2.3%, and 2.0%, respectively, across the same timeframes.

Based on these positive findings, Novo Nordisk is preparing to advance amycretin into further clinical development for adults with overweight or obesity.

About Amycretin

Amycretin is a long-acting, dual-acting GLP-1 and amylin receptor agonist currently under development. This innovative therapy aims to provide an effective and convenient treatment for adults with obesity, overweight, or type 2 diabetes. It is being formulated for both subcutaneous and oral administration to meet the diverse needs of patients.

Details of the Phase 1b/2a Trial

The study was a randomized, placebo-controlled, double-blinded trial. It assessed amycretin’s safety, tolerability, and pharmacokinetics while exploring its potential to reduce body weight. The trial was conducted in five parts:

1. Part A: Single ascending dose to establish pharmacokinetics and determine an appropriate starting dose for subsequent multiple-dose cohorts.

2. Part B: Multiple dose escalation over a total treatment duration of up to 36 weeks to assess safety and tolerability.

3. Parts C, D, and E: Proof-of-concept evaluation, where participants escalated to doses of 1.25 mg, 5 mg, and 20 mg over 12-week intervals to examine weight loss outcomes.