Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity
- Registration Number
- NCT06585462
- Lead Sponsor
- Amgen
- Brief Summary
The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
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) between ≥ 30 kg/m^2 and ≤ 40 kg/m^2.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Multiple Ascending Dose (MAD) in Participants with Obesity (Part B) AMG 513 In Part B participants will enroll into MAD cohorts and will be randomized to receive AMG 513 or placebo SC. Multiple Ascending Dose (MAD) in Participants with Obesity (Part B) Placebo In Part B participants will enroll into MAD cohorts and will be randomized to receive AMG 513 or placebo SC. Single Ascending Dose (SAD) in Participants with Obesity (Part A) AMG 513 In Part A participants will enroll into SAD cohorts and will be randomized to receive AMG 513 or placebo subcutaneously (SC) or intravenously (IV). Single Ascending Dose (SAD) in Participants with Obesity (Part A) Placebo In Part A participants will enroll into SAD cohorts and will be randomized to receive AMG 513 or placebo subcutaneously (SC) or intravenously (IV).
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-emergent Adverse Events (TEAE) Approximately 178 days (Part A) and 225 days (Part B)
- Secondary Outcome Measures
Name Time Method Maximum Observed Drug Concentration (Cmax) of AMG 513 Day 1 up to Day 57 Time to Cmax (Tmax) of AMG 513 Day 1 up to Day 57 Area Under the Concentration-time Curve (AUC) of AMG 513 Day 1 up to Day 57
Trial Locations
- Locations (5)
Anaheim Clinical Trials
🇺🇸Anaheim, California, United States
Orange County Research Center
🇺🇸Lake Forest, California, United States
Fomat Medical Research
🇺🇸Oxnard, California, United States
Translational Clinical Research LLC
🇺🇸Aventura, Florida, United States
Clinical Pharmacology of Miami, LLC
🇺🇸Miami, Florida, United States