HQ Team
July 13, 2025: Denmark’s Novo Nordisk A/S will advance its experimental drug amycretin, in both injection and oral forms, into end-stage trials in weight management based on completed clinical studies, according to a company statement.
Novo Nordisk plans to initiate a Phase 3 development programme with amycretin for adults with overweight or obesity during the first quarter of 2026, it stated.
The decision to advance subcutaneous and oral amycretin into late-stage trials is based on feedback received from regulatory authorities following completion of mid-stage experiments for subcutaneous and oral amycretin in weight management.
Amycretin is a new drug designed to help adults who are overweight or obese, as well as those with type 2 diabetes. It works by targeting GLP-1 and amylin receptors, which help regulate appetite and metabolism. Previous studies showed that amycretin is safe and effective in both injection and oral forms.
Obesity, type 2 diabetes
The amycretin molecule marked an important step forward, and details about the end-stage trials will be shared at a later date, said Martin Lange, executive vice president for Development at Novo Nordisk.
Amycretin is a unimolecular, long-acting GLP-1 and amylin receptor agonist under development by Novo Nordisk, intended to provide an efficacious and convenient treatment for adults with overweight or obesity, as well as for adults with type 2 diabetes. Amycretin is developed for subcutaneous and oral administration.
Oral amycretin’s early trials evaluated the single-ascending dose and multiple-ascending doses for oral amycretin, up to two times 50 mg, in people with overweight or obesity, with a total treatment duration of up to 12 weeks.
At mid-stage, the trial investigated the safety, tolerability, pharmacokinetics, and proof-of-concept of once-weekly subcutaneous amycretin in people with overweight or obesity.
The trial was a combined single ascending dose, multiple ascending dose and dose-response trial investigating three different maintenance doses with a total treatment duration of up to 36 weeks.
Metabolism, appetite
GLP-1 and amylin receptor agonism refers to drugs that activate two specific receptors involved in regulating metabolism, appetite, and blood sugar.
GLP-1 (glucagon-like peptide-1) receptor agonists bind to GLP-1 receptors, which are G-protein-coupled receptors found mainly on pancreatic cells. Activation of GLP-1 receptors increases insulin secretion and decreases glucagon secretion, helping to lower blood sugar levels.
It also slows gastric emptying and suppresses appetite, contributing to weight loss, and acts on pancreatic beta cells to promote insulin release and on α-cells and δ-cells to inhibit glucagon release, maintaining glucose balance.
GLP-1 receptor activation also influences brain regions in control of satiety and food intake, reducing hunger and food reward.
Slow gastric emptying
Amylin is a hormone co-secreted with insulin by pancreatic β-cells. Amylin receptor agonists activate amylin receptors, which are also G-protein-coupled receptors. Amylin slows gastric emptying and promotes satiety by acting on brain areas such as the area postrema and lateral parabrachial nucleus.
This signalling reduces appetite and food intake, aiding weight loss. The drugs in tandem reduce appetite, slow gastric emptying, improve blood sugar control, and promote significant weight loss.
The combination targets multiple mechanisms of energy balance and glucose metabolism, making it a promising approach for obesity and type 2 diabetes treatment.
