The FDA has freed Amgen’s mysterious early-stage obesity asset from a clinical hold, with the phase 1 study now enrolling participants.
The historically tight-lipped Amgen execs remain judicious with what they share, providing few details regarding the matter on a May 1 earnings call.
The candidate in question, dubbed AMG 513, was hit with an FDA hold reported at the beginning of February. While Amgen hasn’t publicly shared the mechanism of AMG 513, the pharma has previously said that it didn't think the issue was related to the drug.
The obesity asset is being tested in a placebo-controlled, single and multiple ascending dose trial that launched in September 2024, according to ClinicalTrials.gov. The trial is expected to enroll about 80 participants with obesity, with a primary readout slated for mid-2026.
Amgen’s obesity efforts have been shadowed by drama, with several prospects being axed and a hidden Excel tab containing data on bone density changes in a phase 1 study of MariTide—the company’s only other clinical obesity prospect—temporarily wiping billions of dollars off the pharma’s market cap last year.
MariTide is a monoclonal antibody linked to a pair of peptides designed to increase GLP-1 receptor activity while tamping down on the receptor for GIP. In November, the company shared phase 2 data that tied monthly doses of the investigational treatment to average weight loss of up to 20% over 52 weeks in individuals with obesity or who are overweight, but without Type 2 diabetes.
Now, the pharma plans to share new data in June on the asset from a phase 2 trial recruiting adults with obesity or who are overweight with or without Type 2 diabetes mellitus. The data will be shared at the American Diabetes Association’s annual meeting in Chicago.
A few months ago, Amgen launched Maritime, a phase 3 program assessing MariTide that includes two freshly launched trials.
The program includes one study for people living with obesity or overweight without Type 2 diabetes, with an expected enrollment of 3,500 participants. Called Maritime-1, the trial has a primary readout date set for the start of 2027.
Meanwhile, Maritime-2 will recruit 999 people living with obesity or who are overweight and Type 2 diabetes, with a readout also expected in the start of 2027.
The pharma said it expects to launch further late-stage trials in other indications—such as atherosclerotic cardiovascular disease, heart failure, chronic kidney disease and obstructive sleep apnea—sometime this year.