Not currently recruiting at UCLA

A Study to See if Lepodisiran Can Reduce Plaque in Coronary Arteries of Adults With Elevated Lp(a) Who Have Had Heart Events or Are at High Risk

a study on Atherosclerosis Peripheral Artery Disease Cardiovascular Disease Lipoprotein(a)

Summary

Eligibility
for people ages 45-80 (full criteria)
Location
at Torrance, California and other locations
Dates
study started
study ends around
Principal Investigator
by Ignacio Velazquez

Description

Summary

Lipoprotein(a), also known as Lp(a), is a protein that carries cholesterol and proteins in your blood. People with high Lp(a) have a higher risk for heart disease. The main purpose of the study is to investigate how lepodisiran, compared to a placebo, affects the amount and type of plaque in the heart's vessels using an imaging technology known as Coronary Computed Tomography Angiography (CCTA) in adults who have high levels of Lp(a).

Participation will last about 120 weeks.

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Lepodisiran to Investigate the Effect on Coronary Plaque in Adults With Elevated Lp(a) Who Have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event

Keywords

Atherosclerosis, Cardiovascular Diseases, Lipoprotein(a), CCTA, Coronary plaque burden, Lepodisiran

Eligibility

You can join if…

Open to people ages 45-80

  • Have an Lp(a) ≥175 nmol/L
  • Have established cardiovascular (CV) disease or are at risk for a first CV event
  • Have angiographic evidence of coronary artery disease on screening CCTA
  • If taking lipid-lowering medications, inclusive of statins or prescription strength niacin and PCSK9 inhibitors, these should be stable for 8 weeks

You CAN'T join if...

  • Have had a major CV event less than 60 days before measurement of the Lp(a) level used for eligibility or uncontrolled high blood pressure at screening
  • Have moderate to severe renal dysfunction
  • Have severe heart failure
  • Have a history of coronary artery bypass graft surgery (CABG)
  • Have a planned coronary angiography, percutaneous coronary intervention (PCI), coronary artery bypass graft, or valvular intervention
  • Have had a procedure to remove lipoproteins from the blood or received therapy specifically targeting Lp(a)
  • Are unable to safely undergo CCTA due to medication intolerance, contrast allergies, or anatomical/technical factors

Locations

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center not yet accepting patients
    Torrance California 90502 United States
  • Valley Clinical Trials, Inc. not yet accepting patients
    Northridge California 91325 United States
  • Vector Clinical Trials accepting new patients
    Las Vegas Nevada 89128 United States
  • Eastside Research Associates accepting new patients
    Redmond Washington 98052 United States

Lead Scientist at UCLA

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
ID
NCT07613294
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 252 study participants
Last Updated