About this Study:

This study is evaluating an investigational treatment aimed at lowering the risk of heart disease in individuals with high Lipoprotein(a) [Lp(a)] and other risk factors. You may be eligible if you have elevated levels of this genetic cholesterol marker.

You may qualify if you:

• Are 50 years of age or older

• Have high Lp(a) levels (≥200 nmol/L)
• Have risk factors for heart disease such as:

• High blood pressure

• • Diabetes
  • High cholesterol
  • Smoking history
• Or have evidence of plaque buildup in your arteries

 You may not qualify if you have:

• A prior heart attack, stroke, or TIA

• Had stents, bypass surgery, or plan to have one soon
• A history of major bleeding disorders

Why participate?

• Help advance research in heart disease prevention

• Compensation may be available (if applicable)

Study Details: 

Location: Jacksonville, FL 

All study- related care is provided at no cost to you or your insurance company.

About this Study:

The study  is designed to test whether a specific drug targeting Lp can reduce the risk of first major cardiovascular (CV) events.

You may qualify if you:

• Age ≥50 years
• Elevated (Lipoprotein (a)) Lp(a) during screening
• Multiple atherosclerotic cardiovascular disease risk factors, and/or evidence of atherosclerosis

 You may not qualify if you have:

• Prior acute atherothrombotic event (myocardial infarction, stroke, transient ischemic attack, acute limb ischemia)
• Prior or planned arterial revascularization
• History of major bleeding disorder

Why participate?

• Help advance research in heart disease prevention

• Compensation may be available (if applicable)

Study Details: 

Location: Jacksonville, FL 

All study- related care is provided at no cost to you or your insurance company.

You may qualify if:

• You are 40 years or older

• You have high lipoprotein(a) [Lp(a)]  -done at screening visit
• You have a higher risk of heart disease, such as:

• Coronary artery disease (CAD)

• • Prior stroke
  • Peripheral artery disease
  • Or conditions like familial high cholesterol or type 2 diabetes
• You have been on a stable dose of certain medications for at least 4 weeks, including:

• Cholesterol-lowering medications

• • Hormone-related treatments (such as estrogen, testosterone, etc.)
• Your body mass index (BMI) is between 18.5 and 40

Why participate?

• Help advance research in heart disease prevention

• Compensation may be available (if applicable)

Study Details: 

Location: Jacksonville, FL 

All study- related care is provided at no cost to you or your insurance company.

You may qualify if you:

• Are 18 to 80 years old

• Have been diagnosed with atherosclerotic cardiovascular disease (heart or blood vessel disease caused by plaque buildup)
• Have elevated lipoprotein(a), or Lp(a) — a type of cholesterol in your blood
• Meet other study requirements (the research team will review these with you)

 You may not qualify if you have:

• Have moderate to severe heart failure or your heart is very weak (ejection fraction below 30%)
• Have very high, uncontrolled blood pressure (160+/100+)
• Had serious or uncontrolled heart rhythm problems in the last 3 months
• Had cancer in the past 5 years, except for certain early-stage or treated cancers
• Do not meet other study requirements (the team will review this with you)

Why participate?

• Help advance research in heart disease prevention

• Compensation may be available (if applicable)

Study Details: 

Location: Jacksonville, FL 

All study- related care is provided at no cost to you or your insurance company.

• You may qualify if you:
• Are 18–80 years old

• Have heart/vascular disease (heart attack, stroke, blocked arteries) 
• Have high Lp(a) and LDL >70 mg/dL
• Are on stable cholesterol treatment
• Meet other study requirements (the research team will review these with you)

You may NOT qualify if you:

• Had a recent heart attack, stroke, or surgery

• Have severe heart failure or uncontrolled BP 
• Have serious liver or kidney disease

Recently used certain advanced cholesterol drugs 

• Do not meet other study requirements (the team will review this with you)

Why participate?

• Help advance research in heart disease prevention

• Compensation may be available (if applicable)

Study Details: 

Location: Jacksonville, FL 

All study- related care is provided at no cost to you or your insurance company.

ELIL J3L-MC-EZEJ Lp(a) CCTA (ELS)

About this study:

This study is for people who have high levels of lipoprotein(a), also called Lp(a), a type of cholesterol in the blood that can increase the risk of heart disease. Researchers are studying whether a medication called lepodisiran can lower Lp(a) and help reduce harmful buildup (plaque) in the heart’s blood vessels.

You may qualify if:

• Your Lp(a) is high (≥175)

• You have heart disease or are at high risk for it
• A heart scan (CCTA) shows plaque in your arteries
• Your cholesterol medications have been stable for at least 8 weeks

You may NOT qualify if:

• You had a recent heart attack or stroke (within 60 days)

• You have serious kidney or heart failure
• You’ve had bypass surgery (CABG)
• You’re planning a heart procedure soon (stent, surgery, etc.)
• You’ve received special treatments to lower Lp(a)
• You can’t safely undergo a CT scan (contrast allergy, etc.)

Why participate?

• Help advance research in heart disease prevention
• Compensation may be available (if applicable) )

Study Details: 

Location: Jacksonville, FL 

All study-related care is provided at no cost to you or your insurance company.

CRISPR Gene Editing Research Study for Refractory Dyslipidemias 

Testing investigational CRISPR gene editing treatment for adults with high cholesterol and/or triglycerides that don’t respond to standard medications 

If you have high cholesterol and/or triglycerides that don’t respond to medications, you may be eligible for a groundbreaking gene editing research study. This study is testing an investigational CRISPR gene editing treatment for adults ages 18-75 with refractory dyslipidemias (high cholesterol and/or triglycerides that remain elevated despite maximum tolerated doses of lipid-lowering medications).

Dyslipidemias are conditions characterized by abnormal levels of lipids (fats) in the blood, including high cholesterol (LDL-C, non-HDL-C, apolipoprotein B) and high triglycerides. These conditions significantly increase the risk of heart disease, stroke, and other cardiovascular complications. For most people, lifestyle changes combined with medications such as statins, ezetimibe, PCSK9 inhibitors (alirocumab or evolocumab), fibrates, omega-3 fatty acids, bile acid sequestrants, bempedoic acid, lomitapide, or inclisiran can effectively lower cholesterol and triglycerides to target levels recommended by the American College of Cardiology and American Heart Association. However, some people have refractory dyslipidemias, meaning their cholesterol and/or triglycerides remain dangerously elevated despite trying multiple medications at maximum tolerated doses for at least 12 weeks. This includes people with genetic conditions like familial hypercholesterolemia (inherited high cholesterol due to gene mutations) and severe hypertriglyceridemia (very high triglycerides often >500 mg/dL).

This is a first-in-human Phase 1 study evaluating the safety and tolerability of CTX310, an investigational CRISPR gene editing treatment. CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is a revolutionary gene editing technology that can make precise changes to DNA. CTX310 uses CRISPR-Cas9 technology delivered in a lipid nanoparticle formulation to edit the ANGPTL3 (angiopoietin-like 3) gene in the liver. By disrupting this gene, CTX310 is designed to permanently decrease ANGPTL3 protein levels, which in turn may result in long-lasting reductions in cholesterol and triglycerides. Unlike daily pills or regular injections that require ongoing treatment, this is a single IV infusion that could potentially provide lasting benefits from a one-time treatment.

The study has two phases. Phase 1a (dose escalation) is enrolling people with various types of refractory dyslipidemias including multifactorial chylomicronemia syndrome, familial hypercholesterolemia, familial chylomicronemia syndrome, and other high cholesterol/triglyceride conditions to determine the optimal dose. Phase 1b (disease-specific cohort expansion) is enrolling people in four specific groups: (1) Severe hypertriglyceridemia (triglycerides >500 mg/dL), (2) Homozygous familial hypercholesterolemia (HoFH – two copies of gene mutation), (3) Heterozygous familial hypercholesterolemia (HeFH – one copy of gene mutation), and (4) Mixed hyperlipidemias (including moderate hypertriglyceridemia).

The study involves a single IV infusion of CTX310 administered at the study site. You will be hospitalized for a minimum of 24 hours after the infusion for safety monitoring. You will then be monitored for 12 months with regular clinic visits to assess safety, measure changes in your cholesterol and triglyceride levels, and evaluate the effects of the gene editing. All participants will be invited to enroll in a separate long-term follow-up study for up to 15 years to track the durability and long-term safety of the treatment.

Important: You must have high cholesterol and/or triglycerides that remain elevated despite being on maximum tolerated doses of lipid-lowering medications for at least 12 weeks before screening. You must continue taking your current lipid-lowering medications during the study. Females must be postmenopausal (no females of childbearing potential can participate due to unknown effects on pregnancy). Males must use effective contraception for 12 months after the infusion. You cannot have had prior gene therapy or gene editing treatment. You cannot have liver disease, kidney disease, recent heart attack (within 24 weeks), recent stroke (within 24 weeks), recent pancreatitis (within 12 weeks), HIV, Hepatitis B, Hepatitis C, or cancer within the past 5 years (with some exceptions for completely resected skin cancers). Study-related care, tests, and investigational treatment are provided at no cost. Compensation is provided. 

You may qualify if you: 

• Are between 18 and 75 years old 
• Have high cholesterol (LDL-C, non-HDL-C, and/or ApoB) and/or high triglycerides above recommended levels 
• Have cholesterol and/or triglycerides that remain elevated despite being on maximum tolerated doses of lipid-lowering medications for at least 12 weeks 
• Are currently taking lipid-lowering medications such as statins, ezetimibe, PCSK9 inhibitors, fibrates, omega-3 fatty acids, bile acid sequestrants, bempedoic acid, niacin, lomitapide, or monoclonal antibodies 
• Are willing to continue taking your current lipid-lowering medications during the study 
• Are on a stable dose of lipid-lowering medications with no planned dose increase during study participation 
• If on apheresis (blood filtering for cholesterol removal): Have been on stable frequency for at least 12 weeks with no planned changes 
• If on inclisiran: Have been on it for at least 365 days and it has not adequately controlled your lipid levels 
• For females: Are postmenopausal (at least 12 months without period, OR surgically sterile with hysterectomy and/or removal of ovaries/fallopian tubes) 
• For males: Are willing to use effective contraception for 12 months after the infusion, and your female partner will also use effective contraception 
• Are willing to be hospitalized for at least 24 hours after the infusion 
• Are willing to attend all study visits over 12 months 
• Are willing to enroll in long-term follow-up study for up to 15 years 
• For Phase 1b disease-specific cohorts: Have severe high triglycerides (>500 mg/dL), HoFH, HeFH, or mixed hyperlipidemias