Novo Nordisk’s Amycretin Achieves Up to 22% Weight Loss in Phase 1b/2a Trial
Weekly subcutaneous injections of amycretin featured a safety profile similar to other incretin-based drugs, according to new topline results.
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Novo Nordisk reported today that amycretin, an investigational glucagon-like peptide-1 (GLP-1) and amylin receptor agonist, led to significant weight reductions in individuals with overweight or obesity in a phase 1b/2a clinical trial.1
The randomized, placebo-controlled 5-part trial enrolled 125 adults and assessed the safety, tolerability, pharmacokinetics, and proof-of-concept of once-weekly subcutaneous amycretin. The trial’s primary endpoint was treatment-emergent adverse events. Weight loss with amycretin was compared with placebo in a proof-of-concept study, according to a January 24 press release.1
The proof-of-concept portion of the trial consisted of 3 parts. In part E, adults were randomly assigned to receive up to 1.25 mg amycretin for 20 weeks or placebo. Part D randomly assigned participants to an ascending dose up to 5 mg amycretin or placebo for 28 weeks. Part C randomly assigned people to receive up to 20 mg of amycretin or placebo for 36 weeks.1
In Part E, adults receiving up to 1.25 mg amycretin lost an estimated 9.7% of body weight compared with a 1.9% weight gain for those receiving placebo. In Part D, the 5 mg amycretin group achieved a 16.2% weight reduction compared with a 2.3% weight gain with placebo at 28 weeks. The 20 mg amycretin group lost 22% of body weight at 36 weeks compared with a 2% weight gain with placebo in Part C.1
The safety profile of amycretin was consistent with other incretin-based therapies, with gastrointestinal events being the most commonly reported. Most adverse events were mild to moderate in severity, reported Novo Nordisk.1
“We are very encouraged by the subcutaneous phase 1b/2a results for amycretin in people living with overweight or obesity,” Martin Holst Lange, MD, PhD, executive vice president for development at Novo Nordisk, said in the press release.1 “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.”
As Patient Care Online previously reported, Novo Nordisk presented findings at the European Association for the Study of Diabetes annual meeting in September revealing an oral form of amycretin conferred a more than 10% weight loss at 12 weeks in people with obesity with no safety concerns.2
Novo Nordisk said it plans to pursue further clinical development of amycretin for the treatment of overweight and obesity based on the phase 1b/2a trial results.1
References:
1. Novo Nordisk successfully completes phase 1b/2a trial with subcutaneous amycretin in people with overweight or obesity. News release. Novo Nordisk. January 24, 2025. Accessed January 24, 2025. https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=915251
2. Jennings S. Novel oral antiobesity drug shown to reduce body weight by up to 13% in first-in-human study. Patient Care Online. September 18, 2024. https://www.patientcareonline.com/view/novel-oral-antiobesity-drug-shown-to-reduce-body-weight-by-up-to-13-in-first-in-human-study
