Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity
ConditionCardiometabolic Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAmgen
About this trial
The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.
Eligibility criteria
Qualifiers
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/m² to 40.0 kg/m² for Part A and BMI of 27.0 kg/m² to 40.0 kg/m² for Part B.
Females enrolled must be of non-childbearing potential.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- AMG 513
- Placebo
- AMG 513
- Placebo
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov