Actively Recruiting
Phase 1 Study to Assess Safety and Effects of AMG 513 Given by Injection in Adults With Obesity
Led by Amgen · Updated on 2026-06-22
80
Participants Needed
10
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This trial evaluates the safety and tolerability of AMG 513 in adults with obesity or overweight. It is a Phase 1, randomized, double-blind study assessing single and multiple doses of AMG 513 compared to placebo. The study is designed to understand how participants tolerate AMG 513 and to collect data on the drugs behavior in the body. Participants are assigned to either a single ascending dose group Part A or a multiple ascending dose group Part B. In Part A, AMG 513 or placebo is given by subcutaneous or intravenous injection. In Part B, AMG 513 or placebo is administered subcutaneously. Both parts involve randomized groups to compare AMG 513 with placebo. During the study, participants undergo safety monitoring for treatment-emergent adverse events over approximately 178 days in Part A and 225 days in Part B. Researchers measure AMG 513 drug levels in the body, including maximum concentration, time to maximum concentration, and overall exposure up to Day 57. The study includes visits for dosing and safety assessments, and participants are observed for tolerability over several months.
CONDITIONS
Brief Title
Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity
Research Team
A
Amgen Call Center
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