Company, Novo Nordisk presented convincing data from two clinical trials that showed the effectiveness of an experimental drug AM833 (analogue amilina for subcutaneous injection) in the treatment of obesity. About this time, according to PharmaTimes.
In the phase II study duration of 26 weeks, evaluated the safety, tolerability and efficacy of monotherapy AM833 with the participation of 706 patients with obesity or overweight and one or more concomitant disease. Participants were randomised into groups the introduction of five different doses AM833, liraglutide or placebo. The results showed a statistically significant superiority of the experimental drug on the background of the application during the week AM833 highest dose (4.5 mg) average weight loss was 10.8%, whereas in the placebo group this indicator was equal to 3%.
In another study, the phase I duration 20 weeks evaluated the safety, tolerability and efficacy of AM833 in combination with semiluteus (2.4 mg) in 80 patients with obesity or overweight. After 20 weeks of treatment, the participants receiving the highest dose AM833, lost an average of 17.1% of body weight (average body weight of participants was 95.1 kg).
In both studies AM833 well tolerated by patients. The most common adverse events were violations of the gastrointestinal tract, including nausea and vomiting mild to moderate severity.