Atherosclerosis study: Lepodisiran
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?
This is an investigational injectable medicine being studied to see if it can reduce plaque in the heart's vessels in people with high levels of a protein called Lp(a). It is designed to lower the amount of Lp(a) in your blood.
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
- The study compares lepodisiran to a placebo to see how it changes the amount and type of plaque in heart arteries using a special CT scan.
- Who it's for
- Adults with high Lp(a) levels who have had heart events or are at high risk for heart disease.
- What's involved
- Participants receive either lepodisiran or a placebo and undergo imaging scans and other tests to measure plaque changes.
- Time commitment
- The study lasts about 120 weeks, with regular visits and scans scheduled throughout that period.
- 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 is enrolling
- 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
- Farmington Hills, Michigan, United States
- Las Vegas, Nevada, United States
- York, Pennsylvania, United States
- Murray, Utah, United States
- Falls Church, Virginia, United States
- Roanoke, Virginia, United States
- Redmond, Washington, United States
- Adelaide, Australia
- Birtinya, Australia
- Brisbane, Australia
- Burwood, Australia
+ 26 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, but 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?
This study is enrolling now at 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 40 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.