Once-daily weight loss drug shows promising results in reducing body weight

At the annual meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain (September 9-13), it was announced that people who received an oral weight loss medication once a day lost up to 13 percent of their body weight within three months.

Amycretin, being developed by the Danish pharmaceutical company Novo Nordisk A/S, mimics the effects of two peptide hormones in a single molecule.

Amycretin is both an amylin and a glucagon-like peptide-1 (GLP-1) receptor agonist. Both play a key role in appetite regulation and hunger and have been shown to lead to weight loss.

Currently, GLP-1-based treatment options are primarily administered through injections, a delivery method also used for the amylin-based treatments in clinical development. To date, there are no tablet-based treatment options that target both of these biological systems.

In a single-center, placebo-controlled, double-blind Phase 1 study, adult participants with a BMI of 25.0-39.9 kg/m² without diabetes were randomized to receive amycretin or placebo once daily for up to 12 weeks.

The study, conducted by Novo Nordisk A/S and a clinical research unit in the US, consisted of single and multiple ascending dose parts in which different doses of amycretin were tested orally: single ascending dose (increasing from 1 mg per day to 25 mg), 10-day multiple ascending doses (investigating from 3 to 12 mg), and 12-week multiple ascending doses (introducing a gradual dose increase, investigating from an initial dose of 3 mg to a final dose of 2 x 50 mg).

In the first human study, amycretin appeared to have a safe and tolerable profile consistent with the drug receptor classes. Side effects were mainly mild to moderate in nature and included nausea and vomiting..

At the end of the experiment, the average was Weight loss was greater with amycretin than with placebo. Participants taking 50 mg of amycretin reduced their body weight by an average of 10.4% over 12 weeks of treatment, while those taking amycretin 2 x 50 mg, the maximum dose tested, achieved a weight loss of 13.1%. In comparison, the average weight loss for those taking a placebo over the same period was 1.1%.

Notably, weight loss in participants taking amycretin had not reached a plateau at the end of the treatment period, suggesting that there is potential for further weight loss with prolonged use.

The authors of the study conclude that daily oral treatment with amycretin in adults with overweight or obesity and without diabetes had a safe and tolerable profile according to the drug receptor classes and resulted in a significant reduction in body weight.

They add: “A single molecule in tablet form that targets both amylin and GLP-1 biology could provide a more convenient approach to achieve better outcomes for individuals who are overweight or obese.

“However, to fully assess the drug’s safety profile and potential, more extensive and longer studies are needed.“