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.
“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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