Cardiometabolic Disease
Conditions
Keywords
AMG 513, Cardiometabolic disease
Brief summary
The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.
Interventions
DRUGAMG 513
AMG 513 will be administered by SC or IV injection.
DRUGPlacebo
Placebo will be administered by SC or IV injection.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAE) | Day 1 up to approximately 150 days after last dose |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Observed Drug Concentration (Cmax) of AMG 513 | Day 1 up to approximately 150 days after last dose |
| Time to Cmax (Tmax) of AMG 513 | Day 1 up to approximately 150 days after last dose |
| Area Under the Concentration-time Curve (AUC) of AMG 513 | Day 1 up to approximately 150 days after last dose |
Countries
United States
Contacts
STUDY_DIRECTORMD
Amgen
Outcome results
None listed