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

Active Not RecruitingPhase 1

Sponsor: Amgen

Conditions: Cardiometabolic Disease

Interventions: AMG 513, Placebo, AMG 513, Placebo

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (13)

Anaheim, California, United States
Lake Forest, California, United States
Oxnard, California, United States
Aventura, Florida, United States
Jacksonville, Florida, United States
Lauderhill, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Union City, Georgia, United States
Fayette, Mississippi, United States
Fargo, North Dakota, United States
Austin, Texas, United States