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
This trial accepts healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
AMG 513
DrugAMG 513 will be administered by SC or IV injection.
Placebo
DrugPlacebo will be administered by SC or IV injection.
AMG 513
DrugAMG 513 will be administered by SC injection.
Placebo
DrugPlacebo will be administered by SC injection.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Single Ascending Dose (SAD) in Participants with Obesity (Part A)Experimental treatment 2 interventions
Group B: Multiple Ascending Dose (MAD) in Participants with Overweight or Obesity (Part B)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of Participants With Treatment-emergent Adverse Events (TEAE)
Time frame
Approximately 178 days (Part A) and 225 days (Part B)Secondary outcomes
1
Maximum Observed Drug Concentration (Cmax) of AMG 513
Time frame
Day 1 up to Day 572
Time to Cmax (Tmax) of AMG 513
Time frame
Day 1 up to Day 573
Area Under the Concentration-time Curve (AUC) of AMG 513
Time frame
Day 1 up to Day 57 Source ClinicalTrials.gov