Novo Nordisk's experimental obesity pill could achieve greater weight-loss than early trial results have indicated, if taken for an extended period, according to a new study.
The Danish pharmaceutical giant behind blockbuster obesity treatment Wegovy and diabetes drug Ozempic saw its shares surge in March after a Phase 1 trial of the Amycretin pill showed weight loss of around 13% after 12 weeks, better than the 6% weight loss patients experienced after 12 weeks in a Wegovy trial.
Presenting detailed data of the Amycretin trial at a medical conference in Madrid on Wednesday, researchers said the drug was given to overweight or obese patients without diabetes at steadily increasing dose strengths. Those receiving the maximum dose of two 50 milligram pills a day had lost an average 13.1% of their weight at the end of the trial versus 1.1% for those on a placebo.
The study shows Amycretin appears to have an acceptable safety and tolerability profile, while the majority of adverse effects reported were mild to moderate in severity and related to gastrointestinal discomfort such as nausea, vomiting and decreased appetite.
"Daily oral Amycretin treatment...led to remarkable reductions in body weight over only 12 weeks," the researchers said in material presented at the conference. "The lack of weight loss plateauing indicates the possibility of achieving further weight reductions with extended treatment."
Novo Nordisk has previously hinted that it could skip a phase 2 trial and instead move straight to a final phase 3 trial, but it said Wednesday that it will wait to evaluate the next steps until it has early study data from an injectable version of the drug next year.
"The safety and tolerability profiles and the magnitude of weight loss support further development of Amycretin, and we are awaiting data from the ongoing phase 1 trial with subcutaneous Amycretin, with expected read-out in 2025," Martin Holst Lange, head of development at Novo Nordisk, said in a statement.
Investigations of Amycretin in larger and longer studies are being planned to fully assess its efficacy and safety profile.
The runaway success of its Wegovy treatment has left Novo Nordisk scrambling to boost manufacturing capacity to meet demand, with the drug still only available in a few markets.
As supply increases and the company is able to launch Wegovy in new markets, the company expects sales to rapidly increase, but it will eventually face increased competition as rivals rush to develop their own treatments and claim a slice of the market currently dominated by Novo Nordisk and Eli Lilly.
Amycretin represents one of the company's next generation of drugs that aims to supercharge weight-loss as it tries to stay ahead of the chasing pack.
The drug mimics the same gut hormone as Wegovy to suppress appetite, delay stomach emptying and control blood sugar, but combines it with amylin, a hormone in the pancreas that also regulates appetite.
Another eagerly awaited drug is CagriSema, a combination of the semaglutide active ingredient in Wegovy and Ozempic with a drug called cagrilintide. It is currently in a Phase 3 trial, having already shown greater blood-sugar control and weight-loss benefits in diabetic patients than those treated with only semaglutide or cagrilintide.
Studies have shown weight-loss and diabetes drugs are also yielding extra health benefits, such as cutting the risks of stroke and heart attacks as well as slowing the progression of kidney failure, prompting Novo Nordisk to expand into areas like cardiovascular diseases and increase focus on treating conditions outside of its core diabetes and weight-loss market.
Write to Dominic Chopping at [email protected]