FDA Lifts Clinical Hold on Amgen's Obesity Drug, Paving Way for Phase 1 Trial

Amgen, a leading pharmaceutical company, has received clearance from the U.S. Food and Drug Administration (FDA) to resume clinical trials for its early-stage obesity asset, AMG 513. The decision comes after a brief clinical hold, signaling a positive development in the company's ongoing efforts to expand its presence in the competitive obesity treatment market.

AMG 513 Trial Resumes with FDA Approval

The FDA's decision to lift the clinical hold on AMG 513 marks a significant milestone for Amgen's obesity research program. The phase 1 study, which was temporarily suspended in early February, is now actively enrolling participants. The trial is designed as a placebo-controlled, single and multiple ascending dose study, with plans to recruit approximately 80 individuals with obesity.

While specific details about AMG 513's mechanism of action remain undisclosed, Amgen executives have previously indicated that the issue leading to the clinical hold was not believed to be related to the drug itself. The company maintains its characteristic discretion regarding the asset, revealing limited information during a recent May 1 earnings call.

According to ClinicalTrials.gov, the study commenced in September 2024 and is expected to yield primary results by mid-2026. This timeline suggests a cautious approach to drug development, allowing for thorough evaluation of safety and efficacy data.

Amgen's Broader Obesity Pipeline: Challenges and Progress

The developments surrounding AMG 513 occur against the backdrop of Amgen's complex history in obesity drug development. The company has faced setbacks, including the discontinuation of several prospects and a controversial incident involving MariTide, Amgen's other clinical-stage obesity treatment.

MariTide, a monoclonal antibody designed to modulate GLP-1 and GIP receptor activity, has shown promising results in recent clinical trials. In a phase 2 study, monthly doses of MariTide led to average weight loss of up to 20% over 52 weeks in individuals with obesity or overweight, excluding those with Type 2 diabetes.

Building on these encouraging outcomes, Amgen has initiated the Maritime phase 3 program for MariTide. This ambitious late-stage development plan includes two major trials:

1. Maritime-1: Targeting 3,500 participants with obesity or overweight without Type 2 diabetes.
2. Maritime-2: Aiming to enroll 999 individuals with obesity or overweight and Type 2 diabetes.

Both trials are expected to deliver primary readouts in early 2027, potentially positioning Amgen as a strong contender in the obesity treatment landscape.

Future Prospects and Expanded Indications

Amgen's obesity research extends beyond weight management, with plans to explore MariTide's potential in treating various related conditions. The company has announced intentions to launch additional late-stage trials this year, focusing on indications such as atherosclerotic cardiovascular disease, heart failure, chronic kidney disease, and obstructive sleep apnea.

As the pharmaceutical industry continues to recognize the far-reaching implications of obesity on overall health, Amgen's multifaceted approach underscores the potential for innovative treatments to address a spectrum of obesity-related disorders.