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Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Single Ascending Dose (SAD) in Participants with Obesity (Part A) 		In Part A participants will enroll into SAD cohorts and will be randomized to receive AMG 513 or placebo subcutaneously (SC) or intravenously (IV).
  • Drug: AMG 513
    AMG 513 will be administered by SC or IV injection.
  • Drug: Placebo
    Placebo will be administered by SC or IV injection.
Experimental
Multiple Ascending Dose (MAD) in Participants with Overweight or Obesity (Part B) 		In Part B participants will enroll into MAD cohorts and will be randomized to receive AMG 513 or placebo SC.
  • Drug: AMG 513
    AMG 513 will be administered by SC injection.
  • Drug: Placebo
    Placebo will be administered by SC injection.

Recruiting Locations

Anaheim Clinical Trials
Anaheim 5323810, California 5332921 92801

Orange County Research Center
Lake Forest 5364514, California 5332921 92630

Fomat Medical Research
Oxnard 5380184, California 5332921 93030

Translational Clinical Research LLC
Aventura 4146429, Florida 4155751 33180

Clinical Pharmacology of Miami, LLC
Miami 4164138, Florida 4155751 33172

More Details

NCT ID
NCT06585462
Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center