Novo Nordisk has unveiled headline results from two clinical trials with a novel once-weekly subcutaneous amylin analogue (AM833) – a Phase II monotherapy trial and a Phase I combination trial of AM833 and once-weekly subcutaneous semaglutide.
The 26-week blinded Phase II monotherapy trial with AM833 investigated safety, tolerability and efficacy for weight management in 706 people with obesity or overweight with at least one weight-related comorbidity.
Patients were randomised to treatment with five different weekly doses of AM833 (0.3mg, 0.6mg, 1.2mg, 2.4mg, 4.5mg), liraglutide 3.0mg or placebo.
The trial reached its primary endpoint by showing a weight loss of 10.8% at week 26 with AM833 at the 4.5mg dose, compared to a weight loss of 3.0 % with placebo, with the difference being statistically significant.
Also, the Danish drugmaker noted that AM833 appeared to have “a safe and well-tolerated profile”.
The 20-week Phase I combination trial investigated safety, tolerability, pharmacokinetics and weight loss potential of AM833 when administrated in combination with semaglutide 2.4 mg in 80 people with obesity or overweight.
After 20 weeks of treatment, participants receiving the highest dose lost an average of 17.1% body weight from a mean baseline body weight of 95.1 kg.
Again, AM833 was found to be well-tolerated, with the most common adverse events being gastrointestinal disorders including nausea and vomiting, the majority being non-serious and mild or moderate in severity.
The level of gastrointestinal disorders observed for the combination of AM833 and semaglutide in the trial was comparable to what is generally seen for glucagon-like peptides-1 (GLP-1) in monotherapy, the firm said.
“We are encouraged by these impressive results and we look forward to further assessing the efficacy and safety of AM833,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “The Phase I and II data with AM833 for weight management, especially the combination with semaglutide, further strengthen Novo Nordisk’s obesity pipeline and hold potential to close the gap between pharmacotherapy and bariatric surgery,” she added.