Genetic Cholesterol Self-Scheduler

BASIC CRITERIA 

1.  Are you between 18 and 80 years old? 
2. Have you been told by a doctor that you have high lipoprotein(a)? Inclusive LPa >150 nmol/L
   1. Note: If unknown, schedule optional LPa pre-screening)
3. Do you have a history of cardiovascular disease such as heart attack, stroke, stent placement, bypass surgery, or blocked arteries OR Type 2 diabetes? 
4. If you have cardiovascular disease or Type 2 diabetes, are you currently taking medications to manage these conditions?  

ANSWERS MUST BE NO 

1. In the past 3 months, have you had any of the following Cardiac events such as a heart attack or stroke?
2. Do you have any planned cardiac procedures planned in the near future such as coronary bypass or stent? 
3.  Do you have severe kidney disease requiring dialysis? 
4.  Do you have a history of drug abuse or alcohol dependency? 
5. Have you ever tested positive for HIV, hepatitis B, or hepatitis C? 
6. Do you have liver disease, or have you been told you have significant abnormal liver function? 
7. Have you ever had a bleeding stroke or major bleeding in your brain? 
8. Do you have a bleeding disorder? 
9.  Have you been diagnosed with severe heart failure where you get short of breath with minimal activity or at rest? (NYHA Class III or IV) 
10. Do you have an irregular heartbeat (such as atrial fibrillation or ventricular tachycardia) that is not controlled with medication? 
11. Do you have Type 1 diabetes or poorly controlled Type 2 diabetes? (HbA1c 8.5% or higher) 
12. Have you had cancer in the past 5 years? (excluding non-melanoma skin cancer, cervical carcinoma in situ, breast ductal carcinoma in situ, stage 1 prostate cancer, or benign tumors) 
13.  Do you have any active infection or chronic disease that is not currently stable? 
14. Are you currently taking, or have you taken high-dose niacin (more than 2000 mg per day) in the past 3 months? (if part of multivitamin, its ok – Not excluded) 
15. Have you had lipid apheresis (a procedure to remove cholesterol from your blood) in the past 3 months? 
16. Are you currently taking herbal supplements or vitamins known to affect cholesterol, such as fish oil, turmeric, or red yeast rice? (ok if stable for 4 weeks before screening) 
17.  Have you participated in another clinical research study or taken an investigational medication in the past 3 months? 
18. Have you ever participated in a Lipoprotein(a) study?  
19. Are you pregnant, breastfeeding, or planning to become pregnant during the study? (Women of childbearing potential must use highly effective birth control) 
    1. (If applicable) Are you unwilling or unable to use highly effective birth control during the study and for 6 months after the last dose? 
20.  Do you have any medical, psychiatric, or other conditions that would make it difficult for you to follow the study requirements or attend all visits? 

ANSWERS MUST BE YES 

1. If you are taking cholesterol medications (such as statins, ezetimibe, or PCSK9 inhibitors), have you been on the same dose for at least 4 weeks? (Note: Must stay on the same dose throughout the study) 
2.  If you are taking diabetes medications or insulin, have you been on the same dose for at least 4 weeks? 
3. If you are taking GLP-1 medications (such as Ozempic, Wegovy, Mounjaro, or Trulicity), have you been on the same dose for at least 6 months? 
4.  If you are taking hormone medications (testosterone, estrogen, anti-estrogens, progesterone, or growth hormone), have you been on the same dose for at least 4 weeks? 
5.  Are you willing to avoid donating blood during the study? 
6.  Are you willing to fast for approximately 8 hours before certain study visits? (water is allowed) 

Additional criteria may apply