Research Study for Elevated Lipoprotein – Lp(a) Self-Scheduler

Basic Criteria: 

• Adults 45–80 years old (or 55–80 if you’ve never had a heart event)
• Have high lipoprotein(a), a type of cholesterol
• Have heart or blood vessel disease, or are at risk for a first heart event
• Able to attend clinic visits and have heart CT scans over about 2 years
• No recent heart attack or stroke and no history of heart bypass surgery

Please note additional criteria will apply 

Answers Must Be No: 

• Acute coronary syndrome, myocardial infarction, stroke, or TIA within the protocol‑defined recent timeframe
• Severe heart failure or reduced ejection fraction below protocol threshold
• History of coronary artery bypass graft surgery (CABG)
• Planned coronary revascularization during the study
• Clinically significant or uncontrolled arrhythmias
• Uncontrolled hypertension
• Inability to safely undergo CCTA with contrast
• Body mass index (BMI) > 35 kg/m²
• Severe renal impairment or end‑stage kidney disease
• Clinically significant liver disease or abnormal liver function beyond protocol limits
• Uncontrolled diabetes mellitus per protocol criteria
• Any condition that could interfere with study participation or interpretation of results
• Prior or current treatment with investigational agents targeting Lp(a)
• Recent participation in another interventional clinical trial within the protocol‑defined washout period
• Use of prohibited concomitant medications
• Pregnant or breastfeeding
• Planning pregnancy during the study or required follow‑up period
• Known hypersensitivity to lepodisiran or its components
• Active or recent malignancy not meeting protocol exceptions
• Serious medical or psychiatric condition compromising safety, consent, or compliance

Answers Must Be Yes 

• Adults 45–80 years of age with established ASCVD, or adults 55–80 years of age without prior ASCVD but at risk for a first cardiovascular event
• Elevated lipoprotein(a) [Lp(a)] per protocol‑defined threshold
• Documented established ASCVD or protocol‑defined risk for a first cardiovascular event
• On stable standard‑of‑care lipid‑lowering therapy, if applicable
• Able to undergo coronary CT angiography (CCTA) with contrast
• Body mass index (BMI) ≤ 35 kg/m²
• Adequate venous access for blood sampling
• Willing and able to comply with all study procedures and visits
• Able to provide written informed consent
• Willing to use protocol‑specified contraception, if of childbearing potential

  Additional criteria will apply

PLEASE NOTE: Please confirm your eligibility before your appointment by calling 352-354-4466

• If you do not see an available appointment, please call 352-354-4466 for availability.

• Transportation may be available. Call 352-354-4466 Compensation may be available for time and travel.