Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity

NCT06585462 · tracked via the Priya Life Science USA tracker

Sponsor

Amgen

Phase

Phase 1

Started

2024-09-09

Last updated

2026-09-09

Condition(s) studied

Cardiometabolic Disease

Investigational drug(s) / intervention(s)

AMG 513PlaceboAMG 513Placebo

AMG 513: AMG 513 will be administered by SC or IV injection.

Placebo: Placebo will be administered by SC or IV injection.

AMG 513: AMG 513 will be administered by SC injection.

Placebo: Placebo will be administered by SC injection.

Study summary

The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Accepted

Inclusion Criteria: * Participants in the study will be males and females 18 to 65 years of age at the time of signing the informed consent with a body mass index (BMI) of 30.0 kg/m\^2 to 40.0 kg/m\^2 for Part A and BMI of 27.0 kg/m\^2 to 40.0 kg/m\^2 for Part B. * Females enrolled must be of non-childbearing potential. Exclusion Criteria: * History and/or clinical evidence of diabetes mellitus, including hemoglobin A1c ≥ 6.5% and/or a fasting glucose of ≥ 126 mg/dL (7 mmol/L) at screening. * Triglycerides ≥ 5.65 mmol/L (i.e., 500 mg/dL) at screening.

Primary outcome measure(s)

Number of Participants With Treatment-emergent Adverse Events (TEAE) — Day 1 up to approximately 150 days after last dose

Trial sites (13)

Facility	City	Region
Anaheim Clinical Trials	Anaheim	California
Orange County Research Center	Lake Forest	California
Fomat Medical Research	Oxnard	California
Translational Clinical Research LLC	Aventura	Florida
Clinical Neuroscience Solutions - Jacksonville	Jacksonville	Florida
South Florida Clinical Research Institute - Lauderhill	Lauderhill	Florida
New Horizon Research Center	Miami	Florida
Clinical Pharmacology of Miami, LLC	Miami	Florida
Clinical Neuroscience Solutions	Orlando	Florida
Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group	Union City	Georgia
Prime Health and Wellness Sky Clinical Research Network Group	Fayette	Mississippi
Lillestol Research LLC	Fargo	North Dakota
Pinnacle Clinical Research	Austin	Texas

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06585462 on ClinicalTrials.gov ↗ ← All trials in the USA