AMG-513: An Emerging Investigational Agent for Obesity

I. Executive Summary

AMG-513 is an early-stage investigational therapeutic agent currently under development by Amgen for the treatment of obesity.[1] This candidate is in Phase 1 clinical trials, signifying Amgen's ongoing strategic commitment to addressing the complex and widespread challenge of metabolic diseases, particularly in the area of weight management.[1] A notable characteristic of AMG-513 at this juncture is its undisclosed mechanism of action, which sets it apart from many other obesity drug candidates that target known biological pathways.[2] This confidentiality, while standard for protecting innovation in early-phase research and development, contributes to both heightened interest and a degree of uncertainty regarding its potential novelty and therapeutic profile.

The cornerstone of AMG-513's current development is a Phase 1 clinical trial, identified as NCT06585462. This study is designed as a randomized, double-blind, placebo-controlled, single and multiple ascending dose investigation. Its primary objectives are to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AMG-513 in participants diagnosed with obesity.[1] The trial encountered a temporary clinical hold imposed by the U.S. Food and Drug Administration (FDA), which was first reported in early February 2025. Amgen indicated that the reasons for this hold were not directly related to the drug candidate itself. The hold was subsequently lifted by May 2025, enabling the trial to resume participant enrollment.[1] The primary data readout from this pivotal Phase 1 study is anticipated in mid-2026, which will be critical in determining the future development trajectory for AMG-513.[1]