NCT06585462 Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity
| NCT ID | NCT06585462 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Amgen |
| Condition | Cardiometabolic Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-09-09 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2024-09-09 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.
Eligibility 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.
Contact & Investigator
MD
STUDY DIRECTOR
Amgen
Frequently Asked Questions
Who can join the NCT06585462 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Cardiometabolic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06585462 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06585462 currently recruiting?
Yes, NCT06585462 is actively recruiting participants. Contact the research team at medinfo@amgen.com for enrollment information.
Where is the NCT06585462 trial being conducted?
This trial is being conducted at Anaheim, United States, Lake Forest, United States, Oxnard, United States, Aventura, United States and 6 additional locations.
Who is sponsoring the NCT06585462 clinical trial?
NCT06585462 is sponsored by Amgen. The principal investigator is MD at Amgen. The trial plans to enroll 80 participants.