This trial evaluated the safety, tolerability, pharmacokinetics, and clinical efficacy of weekly subcutaneous injection of erythromycin in 125 overweight or obese individuals. The study used three different maintenance doses, with a total treatment duration of up to 36 weeks. The primary endpoint is treatment associated adverse events (TEAEs). The safety performance of Amycritin is consistent with the therapy based on incretin. The most common adverse events are gastrointestinal related reactions, and the vast majority are mild to moderate.
The average baseline weight of the patient population who followed treatment was 92.7 kilograms. Patients receiving a dose of 1.25 mg of amycycline experienced a weight loss of 9.7% at 20 weeks, 16.2% at 28 weeks in the 5 mg dose group, and 22.0% at 36 weeks in the 20 mg dose group. In contrast, patients receiving placebo treatment gained 1.9%, 2.3%, and 2.0% in weight, respectively.
Amycretin is a single molecule long-acting GLP-1 receptor and amylin receptor agonist developed by Novo Nordisk, which aims to provide an efficient and convenient treatment scheme for overweight or obese adults and type 2 diabetes adults. Amycritin is being developed into two dosage forms: oral and subcutaneous injection. The clinical trial data of oral amycretin reported at the annual meeting of the European Association for the Study of diabetes (EASD) in 2024 showed that the subjects who received the highest dose of amycretin lost 13.1% of their weight 12 weeks later.
<Reprinted from WuXi AppTec>
