Testing AMG 513 for treating obesity-related cardiometabolic disease
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
This study is testing a new drug called AMG 513 to see if it is safe and well-tolerated in adults with obesity-related health issues.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Amgen Industry-sponsored |
| Locations | 5 sites (Anaheim, California and 4 other locations) |
| Trial ID | NCT06585462 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and tolerability of AMG 513, an investigational drug, in individuals with obesity. Participants will receive either single or multiple doses of AMG 513 or a placebo to determine the drug's effects. The study focuses on adults aged 18 to 65 with a body mass index (BMI) between 30 and 40 kg/m², excluding those with diabetes or high triglycerides. The primary goal is to assess how well the drug is tolerated and its safety profile.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a BMI between 30 and 40 kg/m² who do not have diabetes or significantly elevated triglycerides.
Not a fit: Patients with a history of diabetes or high triglyceride levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients struggling with obesity and related cardiometabolic conditions.
How similar studies have performed: While there have been studies on obesity treatments, the specific approach with AMG 513 is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Anaheim, California and 4 other locations
- Anaheim Clinical Trials — Anaheim, California, United States (Recruiting)
- Carilion Medical Center — Lake Forest, California, United States (Recruiting)
- Fomat Medical Research — Oxnard, California, United States (Recruiting)
- Translational Clinical Research LLC — Aventura, Florida, United States (Recruiting)
- Clinical Pharmacology of Miami, LLC — Miami, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Amgen Call Center
- Email: medinfo@amgen.com
- Phone: 866-572-6436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.