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Recruiting

NCT Number: NCT06585462

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

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

Recruiting

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Key information

Conditions

Cardiometabolic Disease

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials, Anaheim, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AMG 513

Drug

AMG 513 will be administered by SC or IV injection.

Placebo

Drug

Placebo will be administered by SC or IV injection.

Primary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (TEAE)

    Time frame: Approximately 178 days (Part A) and 225 days (Part B)

Secondary outcomes

  1. Maximum Observed Drug Concentration (Cmax) of AMG 513

    Time frame: Day 1 up to Day 57

  2. Time to Cmax (Tmax) of AMG 513

    Time frame: Day 1 up to Day 57

  3. Area Under the Concentration-time Curve (AUC) of AMG 513

    Time frame: Day 1 up to Day 57

Study contacts

Contact information is provided by the study sponsor or research team.

Amgen Call Center

CONTACT

[email protected]

866-572-6436

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 5, 2024
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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