Early trials show that a dual-action weight-loss pill can help individuals lose 13% of their body weight in just three months.
Novo Nordisk claims that the pill enhances the effects of Ozempic and Wegovy without reaching a plateau.
A three-month trial of an experimental weight-loss pill has demonstrated impressive outcomes, with participants losing approximately 13% of their body weight.
This week at the European Association for the Study of Diabetes (EASD) annual meeting in Madrid, Novo Nordisk, the Danish drugmaker responsible for Ozempic and Wegovy, presented the findings from early clinical trials.
Amycretin mimics two hormones that regulate hunger, including amylin, which induces feelings of fullness, and GLP-1, the same hormone used in Ozempic and Wegovy to suppress appetite and increase insulin secretion.
Novo Nordisk's Amycretin is the first treatment to utilize both amylin and GLP-1's distinct biological pathways in a single molecule, according to Martin Holst Lange, executive vice president and head of development at the company.
"The phase 1 study results at EASD demonstrate that amycretin led to a mean change in percentage body weight of -13.1% after 12 weeks of treatment."
Unlike Ozempic and Wegovy, amycretin is taken as a 50-milligram oral pill.
Novo Nordisk reported that participants in a clinical trial who were obese or overweight but did not have diabetes lost more weight when taking amycretin for 12 weeks compared to those on a placebo. Additionally, higher doses of amycretin resulted in even more weight loss.
Consuming the pill daily resulted in approximately a 10% reduction in weight, while those who doubled the dosage experienced a 13% weight loss.
The researchers emphasized that individuals taking amycretin did not experience a "weight loss plateau," and instead, they continued to lose weight while taking it.
According to Agnes Gasoirek, a senior clinical pharmacology specialist at Novo Nordisk, the absence of weight loss plateauing suggests that additional weight reductions may be achievable through prolonged treatment.
‘Dual effect’
The NYU Langone Weight Management Program's director and chief of bariatric surgery, Dr. Christine Ren-Fielding, discussed the drug's effectiveness.
The doctor stated that GLP-1-based treatments, such as Ozempic, have demonstrated significant weight loss outcomes by making patients feel fuller for a longer period and decreasing their appetite, according to a study.
"The addition of amylin, a hormone that regulates insulin and hunger signals, intensifies this effect."
According to Ren-Fielding, this "dual action" makes for a more potent tool to control cravings and caloric consumption.
She stated that the approach is unique because it considers weight management through various physiological pathways, which makes it more comprehensive and potentially more effective than traditional treatments that concentrate on a single mechanism.
Potential risks or side effects
Gastrointestinal issues such as nausea and vomiting are the most commonly reported side effects of amycretin, particularly with higher doses, as stated by Novo Nordisk.
Ren-Fielding pointed out that adverse effects on gastric motility are common with GLP-1 receptor agonists.
"It addresses weight management through multiple physiological pathways."
She advised closely monitoring side effects, particularly GI issues, among obesity patients.
Ren-Fielding stated that although the initial weight loss results are promising, additional research is necessary to confirm that the benefits of the therapy consistently outweigh the risks, particularly when administered over a long period.
‘Not a cure-all’
GLP-1 based drugs, including the new experimental pill, may provide promising results for obesity, but Ren-Fielding emphasized that they are not a cure-all for obesity.
She informed Planet Chronicle Digital that obesity is a complex, ongoing condition that necessitates a holistic, prolonged strategy to manage.
"Combining pharmacological treatments with other interventions can significantly improve the management of the condition."
The doctor suggested that some patients might benefit from surgical interventions, in addition to lifestyle changes like regular exercise, healthy eating, and psychological support to tackle underlying behavioral factors.
She emphasized that obesity is not just about losing weight, but it's a long-term condition that requires continuous management, similar to other chronic diseases.
Next steps
The study's findings are provisional, as they have not yet been published in a peer-reviewed medical journal.
Novo Nordisk has announced that the researchers will continue to study amycretin in the upcoming months.
Lange stated that the safety and tolerability profiles and the magnitude of weight loss support the continued development of amycretin, and we are eagerly anticipating the results of the ongoing phase 1 trial with subcutaneous amycretin, which is expected to be released in 2025.
"If further research supports these initial findings, I can envision it becoming a viable option for those struggling with obesity."
Ren-Fielding stated that the new drug has "potential" to obtain FDA approval due to the success of GLP-1-based drugs in recent years, but emphasized that further testing is necessary.
She informed Planet Chronicle Digital that while the current clinical trials are showing positive results, larger and long-term studies are necessary to accurately evaluate the drug's safety and overall benefits.
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"If additional research confirms these initial results, I can see it as a potential solution for people battling obesity," she continued.
"Although I am hopeful with caution, we have not yet reached the point of widespread availability."
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