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

Description

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

Conditions

Cardiometabolic Disease

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Study Overview

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Study Details

Study overview

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

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.

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

Condition
Cardiometabolic Disease
Intervention / Treatment

-

Contacts and Locations

Anaheim

Anaheim Clinical Trials, Anaheim, California, United States, 92801

Lake Forest

Orange County Research Center, Lake Forest, California, United States, 92630

Oxnard

Fomat Medical Research, Oxnard, California, United States, 93030

Aventura

Translational Clinical Research LLC, Aventura, Florida, United States, 33180

Miami

Clinical Pharmacology of Miami, LLC, Miami, Florida, United States, 33172

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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) between ≥ 30 kg/m\^2 and ≤ 40 kg/m\^2.
  • * Females enrolled must be of non-childbearing potential.
  • * 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Amgen,

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

2026-07-25