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

Last updated: February 11, 2026
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

1

Condition

Diabetes Prevention

Obesity

Treatment

Placebo

AMG 513

Clinical Study ID

NCT06585462
20230022
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants in the study will be males and females 18 to 65 years of age at thetime 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

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.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
September 09, 2024
Estimated Completion Date:
October 01, 2026

Connect with a study center

  • Anaheim Clinical Trials

    Anaheim, California 92801
    United States

    Site Not Available

  • Orange County Research Center

    Lake Forest, California 92630
    United States

    Site Not Available

  • Fomat Medical Research

    Oxnard, California 93030
    United States

    Site Not Available

  • Orange County Research Center

    Tustin, California 92780
    United States

    Site Not Available

  • Anaheim Clinical Trials

    Anaheim 5323810, California 5332921 92801
    United States

    Active - Recruiting

  • Carilion Medical Center

    Lake Forest 5364514, California 5332921 92630
    United States

    Active - Recruiting

  • Fomat Medical Research

    Oxnard 5380184, California 5332921 93030
    United States

    Active - Recruiting

  • Translational Clinical Research LLC

    Aventura, Florida 33180
    United States

    Site Not Available

  • Clinical Pharmacology of Miami, LLC

    Miami, Florida 33172
    United States

    Site Not Available

  • Translational Clinical Research LLC

    Aventura 4146429, Florida 4155751 33180
    United States

    Active - Recruiting

  • Clinical Pharmacology of Miami, LLC

    Miami 4164138, Florida 4155751 33172
    United States

    Active - Recruiting

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