NCT06585462PHASE1RecruitingAccepts Healthy Volunteers
Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity
Amgen
Start Date
9/9/2024
Completion Date
10/1/2026
Summary
The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.
Eligibility Criteria
Age Range: 18 years to 65 years
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.
Interventions
DRUG
AMG 513
DRUG
Placebo
DRUG
AMG 513
DRUG
Placebo
Conditions
Cardiometabolic Disease
Locations
Anaheim Clinical Trials
Anaheim, California 92801
United States
Orange County Research Center
Lake Forest, California 92630
United States
Fomat Medical Research
Oxnard, California 93030
United States
Translational Clinical Research LLC
Aventura, Florida 33180
United States
Clinical Neuroscience Solutions - Jacksonville
Jacksonville, Florida 32256
United States
New Horizon Research Center
Miami, Florida 33165
United States
Clinical Pharmacology of Miami, LLC
Miami, Florida 33172
United States
Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
Union City, Georgia 30291
United States
Lillestol Research LLC
Fargo, North Dakota 58104
United States
Pinnacle Clinical Research
Austin, Texas 78757
United States