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Recruiting
Sponsor ID
20230022

Single and Multiple Ascending Dose Study of AMG 513 in Participants with Obesity

Sponsor ID
20230022
Clinicaltrials.gov ID
NCT06585462
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.

Additional Study Details

Phase
Phase 1
Product
AMG 513
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
80
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events (TEAE)

Timeframe: Approximately 178 days (Part A) and 225 days (Part B)

Secondary Outcome Measures

Maximum Observed Drug Concentration (Cmax) of AMG 513

Timeframe: Day 1 up to Day 57

Time to Cmax (Tmax) of AMG 513

Timeframe: Day 1 up to Day 57

Area Under the Concentration-time Curve (AUC) of AMG 513

Timeframe: Day 1 up to Day 57

Locations

Location
Status
Contact Us
Location
Orange County Research Center
Lake Forest, CA, United States, 92630
Status
Recruiting
Location
Fomat Medical Research
Oxnard, CA, United States, 93030
Status
Recruiting
Location
Anaheim Clinical Trials
Anaheim, CA, United States, 92801
Status
Recruiting
Location
Clinical Pharmacology of Miami, LLC
Miami, FL, United States, 33172
Status
Recruiting
Location
Translational Clinical Research LLC
Aventura, FL, United States, 33180
Status
Recruiting
Location
Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
Union City, GA, United States, 30291
Status
Recruiting
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Study Info
Age
18 - 65 Years
Condition
  • Heart, Blood & Circulatory - Other
    • Sex
    All
    Trial Dates
    Sep 2024 - Oct 2026
    Inclusion and Exclusion 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.