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Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 513 in Participants With Obesity

NCT06585462•Amgen

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (5)

Anaheim Clinical Trials

Anaheim, California, United States

Carilion Medical Center

Lake Forest, California, United States

Fomat Medical Research

Oxnard, California, United States

Translational Clinical Research LLC

Aventura, Florida, United States

Clinical Pharmacology of Miami, LLC

Miami, Florida, United States

Key Dates

Start Date

September 9, 2024

Primary Completion Date

October 1, 2026

Completion Date

October 1, 2026

Last Updated

February 13, 2026

Enrollment

ESTIMATED participants

Conditions

Cardiometabolic Disease

Interventions

AMG 513

DRUG

Placebo

DRUG

AMG 513

DRUG

Placebo

DRUG

Contacts

Amgen Call Center

CONTACT

866-572-6436 medinfo@amgen.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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