RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 513 in Participants With Obesity.

Quick Facts

Study Start:2024-09-09
Study Completion:2026-07-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06585462

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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) between ≥ 30 kg/m\^2 and ≤ 40 kg/m\^2.
  2. * Females enrolled must be of non-childbearing potential.
  1. * 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.
  2. * Triglycerides ≥ 5.65 mmol/L (i.e., 500 mg/dL) at screening.

Contacts and Locations

Study Contact

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

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

Anaheim Clinical Trials
Anaheim, California, 92801
United States
Orange County Research Center
Lake Forest, California, 92630
United States
Fomat Medical Research
Oxnard, California, 93030
United States
Translational Clinical Research LLC
Aventura, Florida, 33180
United States
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33172
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-09
Study Completion Date2026-07-25

Study Record Updates

Study Start Date2024-09-09
Study Completion Date2026-07-25

Terms related to this study

Keywords Provided by Researchers

  • AMG 513
  • Cardiometabolic disease

Additional Relevant MeSH Terms

  • Cardiometabolic Disease