Amycretin, an oral weight loss drug, led to up to 13% body weight reduction in three months, showing potential for continued weight loss. While well-tolerated, further long-term studies are needed to evaluate its safety and efficacy.
Individuals who received a once-a-day oral weight loss drug had lost up to 13% of their body weight over three months, according to a recent presentation at the annual meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain (9-13 September).
Amycretin, which is being developed by the Danish pharmaceutical company Novo Nordisk A/S, mimics the action of two peptide hormones in one single molecule.
Amycretin is both an amylin and glucagon-like peptide-1 (GLP-1) receptor agonist. Both of these play a key role in appetite regulation and feelings of hunger and have been shown to lead to weight loss.
Current Treatments and Study Design
Currently, GLP-1 based treatment options are mainly administered via injections, a delivery method also used for the amylin-based treatments undergoing clinical development. To date, there are no tablet-form treatment options targeting both of these biologies.
In a single-center, placebo-controlled, double-blinded phase 1 study, adult participants with a BMI of 25.0-39.9 kg/m2 without diabetes were randomized to receive amycretin or a placebo once-a-day for up to 12 weeks.
The study, which was conducted by Novo Nordisk A/S, and a clinical research unit in the US, consisted of single- and multiple ascending dose parts, where different doses of amycretin were tested orally: single-ascending dose (increasing from 1 mg a day to 25 mg)10-day multiple-ascending doses (investigating from 3 to 12 mg), and 12-week multiple-ascending doses (by introducing stepwise dose escalation, investigating from a start dose of 3 mg and up to a final dose of 2×50 mg).
In the first-in-human trial, amycretin appeared to have a safe and tolerable profile in line with the drug receptor classes. Side effects were mainly mild to moderate in severity and of gastrointestinal nature including nausea and vomiting.
Weight Loss Results
At the end of the trial, average weight loss was greater with amycretin than with the placebo. Participants taking amycretin 50 mg reduced their body weight by 10.4%, on average, within 12 weeks of treatment, while those taking amycretin 2x50mg, the maximum dose tested, achieved a body weight reduction of 13.1%. This compares to an average weight loss of 1.1% among those taking placebo during the same time.
Notably, at the end of the treatment period, weight loss had not reached a plateau for participants taking amycretin, indicating the potential for further weight loss with extended use.
The study’s authors conclude that daily oral amycretin treatment in adults with overweight or obesity and without diabetes demonstrated a safe and tolerable profile in line with the drug receptor classes, and with notable reductions in body weight.
They add: “A single molecule that targets both amylin and GLP-1 biology in a tablet form could offer a more convenient approach to achieving better outcomes for individuals with overweight or obesity.
“However, larger and longer studies are needed to fully assess the drug’s safety profile and potential.”
Meeting: Annual Meeting of the European Association for the Study of Diabetes (EASD)
