Novel obesity drug induces up to 22% weight loss with no safety concerns
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Key takeaways:
- Subcutaneous amycretin featured a safety profile similar to other incretin-based drugs in a phase 1b/2a trial.
- Adults with obesity lost more weight with 1.25 mg, 5 mg and 20 mg amycretin vs. placebo.
A novel GLP-1 and amylin receptor agonist featured a safety profile similar to other incretin-based therapies and conferred a significant weight reduction compared with placebo, according to top-line results from a phase 1b/2a trial.
Amycretin (Novo Nordisk) is a once-weekly subcutaneous agent currently under development for the treatment of overweight or obesity and type 2 diabetes. There were 125 adults with overweight or obesity enrolled in a five-part trial. The trial’s primary endpoint was treatment-emergent adverse events. Weight loss with amycretin was compared with placebo in a three-part proof-of-concept study.
According to the release, the safety profile of amycretin was consistent with incretin-based therapies. Most adverse events were mild to moderate in nature, with the most common adverse events being gastrointestinal.
The proof-of-concept portion of the trial consisted of three 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.
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 vs. a 2% weight gain with placebo in Part C.
“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 a press release. “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 Healio 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.
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, according to the release.
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