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Daily Briefing

Amgen's new monthly weight-loss drug shows promise in trial


Results from a Phase 1 trial of Amgen's experimental weight loss drug maridebart cafraglutide, (MariTide), showed the drug promoted significant weight loss with an acceptable safety profile, and only requires patients to take the drug once a month.

Drug and trial details

According to Amgen, MariTide contains a monoclonal antibody, which is a type of drug that lasts longer in the body than other medications. The drug is designed to activate the GLP-1 hormone, which is associated with the feeling of fullness, and block the activity of the GIP gut hormone, which is linked to fat storage and metabolic regulation.

This is notably different from other weight loss drugs like Wegovy, which only activates the GLP-1 hormone, and Zepbound, which activates both the GLP-1 and GIP hormones. MariTide is also designed to be taken monthly, as opposed to other weight loss drugs, which are taken weekly.

For the trial, published in Nature Metabolism, 49 participants received different doses of MariTide, ranging from 21 milligrams to 840 milligrams. All participants in the study were obese but didn't have any other underlying health conditions like diabetes.

The most common side effects related to MariTide were nausea and vomiting. One patient, who was given a 140 milligram dose of the drug, saw elevated levels of pancreatic enzymes, as did another patient who also received 140 milligrams in a multiple-dose group.

The researchers also found that levels of HbA1c, a blood sugar measurement, were in the non-diabetic range at the start of the trial and decreased in every dose group by day 85. However, HbA1c numbers trended back toward baseline during the follow-up period at day 207.

In late 2022, Amgen announced the Phase 1 trial found that, at the highest tested dose provided for 12 weeks, MariTide led to a mean weight loss of 14.5% body weight and that patients maintained that weight loss for 70 days.

Discussion

In research on other drugs like Zepbound and Wegovy, patients quickly regained their weight after stopping treatment. So, according to Narimon Honarpour, Amgen's head of global clinical development, these trial findings are notable since participants were able to maintain their weight loss for 70 days following their last dose.

Honarpour added that Amgen anticipates patients would need to continue taking some amount of MariTide to continue getting its benefits rather than being able to completely stop taking the drug. However, he said, "we do want to be students of the data" and that Amgen will see what happens in trials when participants stop taking MariTide.

Randy Seeley, director of the Michigan Nutrition Obesity Research Center, noted that patients' ability to maintain their weight loss for an extended period while the drug isn't circulating in their bodies is intriguing.

"The most interesting thing that is in the data is the hint that when you take the molecule away, you do not get the level of weight rebound that you would expect," he said.

Seeley said he believes it makes sense for drugmakers to prioritize developing longer-lasting therapies within the obesity space.

"For me, the most important thing that we could do is to get closer to one and done versions of this," he said. "The notion that we could build pharmaceutical interventions that would have long lasting effects beyond the status of the drug is incredibly intriguing." (Beasley, Reuters, 2/5; Chen, STAT+, 2/5)


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