Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity
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
Amgen
80 participants
Sep 9, 2024
INTERVENTIONAL
Conditions
Summary
The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.
Eligibility
Inclusion Criteria2
- 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 Criteria2
- 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.
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Interventions
AMG 513 will be administered by SC or IV injection.
Placebo will be administered by SC or IV injection.
AMG 513 will be administered by SC injection.
Placebo will be administered by SC injection.
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT06585462