
outside of Novo Nordisk, manufacturers of new weight loss drug amycretin
Drug manufacturer Novo Nordisk’s amycretin, an experimental weight-loss pill in clinical trials, may boast substantial weight loss results comparable to those of popular GLP-1 injectables like Ozempic and Wegovy (both of which were created by the same company). And now, an injectable version of amycretin has shown even more impressive weight loss results in a recently-released study. Here’s what we know so far about the new obesity drugs in clinical development.
Early clinical trials show significant weight loss with amycretin
Novo Nordisk has released results from early-stage trials from both the amycretin pill and injectable amycretin.
Amycretin pill weight loss results
Data from the trial suggests that amycretin, a combination agonist of GLP-1 and amylin (a hormone that helps regulate blood sugar), was associated with a lower body weight after 12 weeks.
Researchers presented the results at the 60th annual meeting of the European Association for the Study of Diabetes (EASD) in September 2024.
Participants in this first-in-human study using the drug had a BMI of 25 to 39.9 and no diabetes. They were randomized to receive once-daily oral amycretin or a placebo. After three months, those taking amycretin lost 13.1 percent of their body weight, which was considered significantly greater than that of the placebo group.
Adverse events amongst those taking the pill were considered mild to moderate, say researchers. Like many other GLP-1s, side effects were related to gastrointestinal discomforts including nausea, vomiting and decreased appetite. Symptoms were considered to be in an acceptable safety and tolerability range, the study found.
Injectable amycretin weight loss results
On January 24, Novo Nordisk released phase 1b/2a clinical trial results on injectable amycretin, which was tested in 125 participants with overweight or obesity over 36 weeks.
Participants with a baseline weight of 204 pounds saw an estimated body weight loss of 9.7 percent at a 1.25 mg dose (20 weeks), 16.2 percent at 5 mg (28 weeks) and 22.0 percent at 20 mg (36 weeks).
In contrast, the placebo group gained an estimated 1.9 to 2.3 percent in body weight, according to the company. By comparison, those taking Ozempic typically experience a 15 percent weight loss.
“The results seen in the trial support the weight lowering potential of this novel unimolecular GLP-1 and amylin receptor agonist, amycretin, that we have previously seen with the oral formulation,” said Martin Lange, executive vice president for Development at Novo Nordisk, in a press release.
Experts respond to weight loss drug amycretin
While these findings are very much preliminary and necessary protocols will likely take several years to complete, we checked in with our experts for their initial thoughts on the potential of amycretin.
“Given the current data, amycretin may affect the mechanism of the gut-brain axis and has an impact on hunger-regulating peptides such as GLP-1,” offers Michael Lahey, MD, weight loss physician with My Weight Loss Partner. “It may work like other drugs such as semaglutide to decrease hunger, enhance feelings of satiety and [improve] glycemic control, all of which help with shedding pounds.”
The initial data on amycretin is encouraging, especially knowing that GLP-1 agonist medications—as well as dual-acting GLP-1 and GIP agonists—have already proven to be safe and effective for both weight loss and the management of type 2 diabetes, says HaVy Ngo-Hamilton, Pharmd.D, pharmacist and clinical consultant at BuzzRx.
“I do not have any specific concerns about amycretin and believe that this medication holds significant promise as it mimics the actions of two natural hormones in the body: GLP-1 and amylin, while Wegovy and Ozempic are designed to target only GLP-1 receptors,” she adds. “However, it is essential to establish a robust safety profile for amycretin through further well-designed studies.”
Amycretin side effects are similar to semaglutide
The fact that gastrointestinal side effects have been observed with amycretin is typical for medications that mirror natural gut hormones, says Ngo-Hamilton.
However, she raises the importance of currently-missing detailed information including participants who withdrew from the clinical trial studying the oral pill version of amycreton.
“While the initial findings are encouraging, it is imperative that we conduct further research on amycretin’s safety profile,” Ngo-Hamilton explains. “Comprehensive studies with larger samples will be necessary to gain a reliable understanding of its effectiveness in diabetes treatment and weight management in real-life settings.”
How soon will amycretin for weight loss be available?
Several critical steps are necessary before amycretin can be made available for clinical use, says Dr. Lahey:
- Larger clinical trials: The amycretin pill is set to undergo Phase III trials to evaluate its efficacy, safety and side effects. Such trials have to also encompass the targeted groups to ensure that the medication proves useful for everyone with the disease, he explains. Based on the results of injectable amycretin, Novo Nordisk is also planning further clinical development.
- Regulatory review: Upon the end of the clinical trials, the information will be presented to the necessary committees such as the FDA. These administrations will draw out a risk-benefit ratio and sum up any side effects that were recorded during the trials, he adds.
- Manufacturing and distribution: If amycretin passes clinical trials, there will be calls to increase the production quantity and efficiently organize the delivery of products to the consumer, says Dr. Lahey. Healthcare providers will then need to familiarize themselves with the new prescription.
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