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

Last updated: April 23, 2025
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

1

Condition

Obesity

Diabetes Prevention

Treatment

AMG 513

Placebo

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) between ≥ 30kg/m^2 and ≤ 40 kg/m^2.

  • 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: AMG 513
Phase: 1
Study Start date:
September 09, 2024
Estimated Completion Date:
July 25, 2026

Connect with a study center

  • Anaheim Clinical Trials

    Anaheim, California 92801
    United States

    Active - Recruiting

  • Orange County Research Center

    Lake Forest, California 92630
    United States

    Active - Recruiting

  • Fomat Medical Research

    Oxnard, California 93030
    United States

    Active - Recruiting

  • Orange County Research Center

    Tustin, California 92780
    United States

    Site Not Available

  • Translational Clinical Research LLC

    Aventura, Florida 33180
    United States

    Active - Recruiting

  • Clinical Pharmacology of Miami, LLC

    Miami, Florida 33172
    United States

    Active - Recruiting

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