Clinical trial
Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity
Recruiting now · Phase 1 · 1 countries · Registry ID NCT06585462
Recruiting nowPhase 1Interventional
What this study is about
The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 65 Years
SexAll
Healthy volunteersAccepted
ConditionCardiometabolic Disease
Full registry criteria
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.
Treatments and study arms
AMG 513
Drug
AMG 513 will be administered by SC or IV injection.
Placebo
Drug
Placebo will be administered by SC or IV injection.
AMG 513
Drug
AMG 513 will be administered by SC injection.
Placebo
Drug
Placebo will be administered by SC injection.
Primary outcomes
Number of Participants With Treatment-emergent Adverse Events (TEAE)Approximately 178 days (Part A) and 225 days (Part B)
Study locations
10 locations were listed when this page was built. The first 40 are shown.
Anaheim Clinical Trials🇺🇸 Anaheim, California, United States
Pinnacle Clinical Research🇺🇸 Austin, Texas, United States
Translational Clinical Research LLC🇺🇸 Aventura, Florida, United States
Lillestol Research LLC🇺🇸 Fargo, North Dakota, United States
Clinical Neuroscience Solutions - Jacksonville🇺🇸 Jacksonville, Florida, United States
Orange County Research Center🇺🇸 Lake Forest, California, United States
Clinical Pharmacology of Miami, LLC🇺🇸 Miami, Florida, United States
New Horizon Research Center🇺🇸 Miami, Florida, United States
Fomat Medical Research🇺🇸 Oxnard, California, United States
Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group🇺🇸 Union City, Georgia, United States