Promising early data details on Amgen weight-loss drug published
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[February 05, 2024]
By Deena Beasley
(Reuters) - Animal and early-stage human trial data for Amgen's
experimental obesity drug published in a medical journal showed that it
promoted significant weight loss with an acceptable safety profile, the
company said on Monday.
The dataset published in Nature Metabolism details outcomes and adverse
events for the 49 patients in the Phase 1 trial of the drug, maridebart
cafraglutide. Trial participants received different doses of the drug
ranging from 21 milligrams to 840 mg. Patients in the study were obese,
but did not have other underlying health conditions such as diabetes.
The most common treatment related side effects were nausea and vomiting.
One patient given a single 140 mg dose of the drug experienced elevated
levels of pancreatic enzymes, as did another patient treated with 140 mg
in the multiple dose group.
Amgen said the injected drug, also known as MariTide, links a compound
designed to activate the GLP-1 hormone associated with a feeling of
fullness to an antibody that blocks activity of a different gut hormone,
GIP, that has been linked to fat storage and metabolic regulation.
The company first announced in late 2022 that the Phase 1 clinical trial
showed that at the highest monthly dose tested, given for 12 weeks, the
drug led to mean loss of 14.5% of body weight and that patients
maintained that for 70 days.
Those findings are especially noteworthy given data that has since
emerged showing that patients on current popular treatments like Eli
Lilly's Zepbound and Novo Nordisk's Wegovy quickly gain weight back
after stopping treatment, said Narimon Honarpour, Amgen's head of global
clinical development.
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![](../images/020524PIX/health17.jpg)
An Amgen sign is seen at the company's office in South San
Francisco, California October 21, 2013. REUTERS/Robert
Galbraith/File Photo
![](http://archives.lincolndailynews.com/2024/Feb/05/images/ads/current/peasley_lda_051513.png) "Our data has not changed, but the
context probably has," he said.
Four out of eight participants in the 420 mg segment of the
multiple-dose cohort dropped out of the study after their first
dose. Amgen said it appeared those patients did not want to continue
participating in a clinical trial, and that there was no indication
they had experienced adverse events beyond those seen with other
participants.
Levels of HbA1c, a measure of blood sugar, were in the non-diabetic
range at the beginning of the trial, decreased in all dose groups by
day 85, but trended back toward baseline during the safety follow-up
period at day 207, the researchers reported.
Amgen is currently conducting a Phase 2 trial of MariTide with
results expected late this year.
(Reporting By Deena Beasley; Editing by Bill Berkrot)
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