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New treatment option for Atherosclerosis
Official title 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
ClinicalTrials.gov ID: NCT07613294
What this study is testing
What is Lepodisiran?
Lepodisiran is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for atherosclerosis.
Also referred to as LY3819469.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 80
You may be able to join if
- 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 likely 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...
- 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)
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Northridge, California, United States
- Torrance, California, United States
- Fort Lauderdale, Florida, United States
- Jacksonville, Florida, United States
- Merritt Island, Florida, United States
- Miami Lakes, Florida, United States
- Winter Park, Florida, United States
- Meridian, Idaho, United States
- Boston, Massachusetts, United States
- Farmington Hills, Michigan, United States
- Las Vegas, Nevada, United States
- York, Pennsylvania, United States
- Murray, Utah, United States
- Leesburg, Virginia, United States
- Roanoke, Virginia, United States
- Redmond, Washington, United States
- Adelaide, Australia
- Birtinya, Australia
- Brisbane, Australia
+ 31 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Northridge, California, United States; Torrance, California, United States; Fort Lauderdale, Florida, United States; Jacksonville, Florida, United States; Merritt Island, Florida, United States and 45 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.