The Amgen logo is displayed outside Amgen headquarters in Thousand Oaks, California, on May 17, 2023.
Mario Tama | Getty Images
Amgen on Wednesday said it has started two critical late-stage trials for its experimental weight loss injection MariTide, another step in its bid to enter the booming obesity drug market.
“We’re delighted to share that these trials have now been initiated, and really, the progression of the MARITIME program is going very, very well,” Dr. Jay Bradner, Amgen’s executive vice president of research and development, said during a TD Cowen conference, using the name of the drug’s phase three development program.
MariTide is a monthly injection that investors hope could compete against existing weight loss drugs from Novo Nordisk and Eli Lilly, which are weekly injectables. They are part of a class of drugs called GLP-1s, which mimic certain hormones produced in the gut to tamp down appetite and regulate blood sugar.
About 6% of U.S. adults, or more than 15 million people, were using a prescription for GLP-1s as of May, according to a survey from health policy organization KFF. Some analysts expect the market for GLP-1s to be worth more than $150 billion annually by the early 2030s.
One of the new phase three trials is examining Amgen’s drug in around 3,500 people with obesity or who are overweight without Type 2 diabetes, Bradner said. The second study examines MariTide in 999 patients who are obese or overweight and have Type 2 diabetes
The main goal of both studies is to measure the percentage of weight loss at 72 weeks. Amgen will study three target doses of MariTide and plans to use dose escalation, or starting patients at a lower dose of the drug and increasing that amount over time. The company did not share a specific regimen for dosing in the trials.
Amgen in November said MariTide helped patients with obesity lose up to 20% of their weight on average after a year in a phase two trial, with no weight loss plateau. The drug also helped patients with obesity and Type 2 diabetes lose up to 17% of their weight after a year with no plateau. But the results were on the lower end of Wall Street’s lofty expectations for the drug.
Amgen will report more data on MariTide this year. The full results of the phase two trial will be presented at the American Diabetes Association conference in June. The company is also continuing to study patients in an extension of that trial that will read out in the second half of this year.
MariTide brings a new approach to weight loss compared with the existing drugs on the market because it is a so-called peptide antibody conjugate, which refers to a monoclonal antibody linked to two peptides. The peptides activate receptors of a gut hormone called GLP-1, while the antibody blocks receptors of another hormone called GIP.
That’s unlike Eli Lilly’s obesity drug, Zepbound, which activates both GIP and GLP-1. Novo Nordisk’s Wegovy activates GLP-1 but does not target GIP, which may also affect how the body breaks down sugar and fat.
