Mechanistic Clinical Trial of PCSK9 Inhibition for AAA

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06081153
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Abdominal Aortic Aneurysm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — DRUG
    See arm description.
  • Placebo — DRUG
    See arm description.

Study Details

The goal of this mechanistic clinical trial is to assess whether lowering the low-density lipoprotein cholesterol (LDL-C) levels in the blood with the injections of the medication evolocumab will have any effect on the tissue or cells of patients with abdominal aortic aneurysm (AAA). Researchers will compare participants receiving evolocumab injections to participants receiving placebo injections to see how the tissue and cells of the aorta are affected by changes in LDL-C levels.

Key Dates

Start date
Dec 1, 2026
Status verified
Apr 2026
Primary completion
Jan 15, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Evolocumab
    Evolocumab is the drug that will be administered in this study. It will be administered as a 140mg subcutaneous injection every 14 days for 5 weeks (for a total of 3 doses).
  • Placebo Comparator: Placebo
    This arm is a matching placebo that will be administered in the same fashion as the study drug if the patient is randomized to placebo.

Primary Outcome Measure

Interleukin (IL)-6 in myeloid derived monocytes/macrophages from in AAA tissue [ Time Frame: AAA Repair (Week 5) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19010
Scott Damrauer, MD
[email protected]
215-6140176

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By research site
Hospital of the University of Pennsylvania· Philadelphia, PA

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