Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity
Recruiting · NCT06585462 · Interventional (participants receive a specific treatment) · Lead sponsor: Amgen
View the official record on ClinicalTrials.gov →Interventions studied
AMG 513Placebo
What this trial is about
The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
10 locations listed across 5 US states.
- 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 Neuroscience Solutions - Jacksonville - Jacksonville, Florida, United States
- New Horizon Research Center - Miami, Florida, United States
- Clinical Pharmacology of Miami, LLC - Miami, Florida, United States
- Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group - Union City, Georgia, United States
- Lillestol Research LLC - Fargo, North Dakota, United States
- Pinnacle Clinical Research - Austin, Texas, United States