Actively Recruiting
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
Led by Amgen · Updated on 2026-06-04
80
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AMG 513 in adults with obesity to assess its safety and tolerability after single and multiple doses. This Phase 1 trial focuses on participants with a body mass index (BMI) ranging from overweight to obese levels. The study aims to understand how the drug behaves in the body and its potential effects on cardiometabolic health. The study includes two parts: Part A involves single ascending dose (SAD) cohorts where participants are randomly assigned to receive AMG 513 or a placebo by subcutaneous (SC) or intravenous (IV) injection. Part B involves multiple ascending dose (MAD) cohorts with random assignment to AMG 513 or placebo given by SC injection. Both parts use a randomized, double-blind, placebo-controlled design to evaluate the drug's safety and pharmacokinetics. Participants will be monitored closely for treatment-emergent adverse events over approximately 178 days in Part A and 225 days in Part B. Researchers will measure drug concentration levels and timing, including maximum observed concentration and area under the concentration-time curve over about two months. Safety, tolerability, and pharmacodynamic responses will be assessed through scheduled visits and evaluations during the study period.
CONDITIONS
Brief Title
Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years at the time of informed consent
- Body mass index (BMI) of 30.0 to 40.0 kg/m² for Part A
- Body mass index (BMI) of 27.0 to 40.0 kg/m² for Part B
- Females must be of non-childbearing potential
You will not qualify if you...
- History or clinical evidence of diabetes mellitus, including hemoglobin A1c ≥ 6.5% or fasting glucose ≥ 126 mg/dL at screening
- Triglycerides ≥ 5.65 mmol/L (500 mg/dL) at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 57 days
Participants receive AMG 513 or placebo by subcutaneous or intravenous injection in single ascending dose or multiple ascending dose cohorts.
Multiple visits during dosing and assessments
Duration - Up to 225 days depending on cohort
Participants are monitored for safety and treatment-emergent adverse events after dosing ends.
Periodic follow-up visits
Trial Site Locations
Total: 7 locations
1
Anaheim Clinical Trials
Anaheim, California, United States, 92801
Actively Recruiting
2
Orange County Research Center
Lake Forest, California, United States, 92630
Actively Recruiting
3
Fomat Medical Research
Oxnard, California, United States, 93030
Actively Recruiting
4
Translational Clinical Research LLC
Aventura, Florida, United States, 33180
Actively Recruiting
5
New Horizon Research Center
Miami, Florida, United States, 33165
Actively Recruiting
6
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States, 33172
Actively Recruiting
7
Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
Union City, Georgia, United States, 30291
Actively Recruiting
Research Team
A
Amgen Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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