Status:
RECRUITING
Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity
Lead Sponsor:
Amgen
Conditions:
Cardiometabolic Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 22 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06585462
Start Date
September 9 2024
End Date
July 22 2026
Last Update
August 13 2025
Active Locations (5)
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1
Anaheim Clinical Trials
Anaheim, California, United States, 92801
2
Orange County Research Center
Lake Forest, California, United States, 92630
3
Fomat Medical Research
Oxnard, California, United States, 93030
4
Translational Clinical Research LLC
Aventura, Florida, United States, 33180