Lipoprotein(a) / Heart Health Self-Scheduler

BASIC CRITERIA 

• Age between 18 and 80 years old 
• BMI 18.5 and 40 (inclusive) 
• Must have either a history of cardiovascular disease such as heart attack, stroke, stent placement, bypass surgery, or blocked arteries OR Type 2 diabetes and currentlytaking medications to manage these conditions. 
  • anti-diabetic medications including insulin must be on a stable regimen and dose for a minimum of 4 weeks 
  • GLP1- based therapies (e.g. as a treatment for T2DM, overweight/obesity, or other) should have been taking a stable dose for at least 6 months

ANSWERS MUST BE NO 

• In the past 12 weeks, have you had any of the following: heart attack, unstable chest pain, heart surgery, stent placement, stroke, mini-stroke (TIA), or any procedure to unblock arteries in your heart, neck, or legs? 
• Do you have any planned heart surgery, stent procedures, or other major surgery scheduled during the next 2 years? 
• Do you have a history of drug abuse or alcohol dependency? 
• Do you have severe kidney disease (stage 4 or 5) or are you on dialysis? 
• Have you ever tested positive for HIV, hepatitis B, or hepatitis C? 
• Are you pregnant, breastfeeding, or planning to become pregnant during the study? (Women of childbearing potential must use highly effective birth control) 
• Do you have liver disease or have you been told you have abnormal liver function? 
• Have you ever had a bleeding stroke or major bleeding in your brain? 
• Do you have a bleeding disorder such as hemophilia? 
• Do you have severe heart failure where you get short of breath with minimal activity or at rest? (NYHA Class III or IV) 
• Have you been told your heart’s pumping function (ejection fraction) is less than 30%? 
• Do you have an irregular heartbeat (such as atrial fibrillation or ventricular tachycardia) that is not controlled with medication? 
• Do you have uncontrolled high blood pressure? (typically above 160/100 despite medication) 
• Do you have Type 1 diabetes or poorly controlled Type 2 diabetes? (HbA1c 8.5% or higher) 
• 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) 
• Do you have any active infection or chronic disease that is not currently stable? 
• Are you currently taking or have you taken high-dose niacin (more than 2000 mg per day) in the past 3 months? 
• Have you taken any of the following medications in the past year: anacetrapib, dalcetrapib, evacetrapib, obicetrapib, or lomitapide? 
• Have you had lipid apheresis (a procedure to remove cholesterol from your blood) in the past 3 months? 
• Have you taken any herbal supplements or vitamins known to affect cholesterol, such as fish oil, turmeric, or red yeast rice within the last 4 weeks?  
• Have you participated in another clinical research study or taken investigational medication in the past 3 months? 
• Have you ever taken experimental RNA-based therapies such as siRNA or antisense oligonucleotides? (mRNA COVID vaccines are okay) 
• Are you currently taking or planning to take any experimental therapy to lower lipoprotein(a)? 
• Do you have any medical, psychiatric, or other condition that would make it difficult for you to follow the study requirements or attend all visits? 

ANSWERS MUST BE YES 

• Are you willing to use highly effective birth control during the study and for 6 months after the last dose? Note: In case of use of hormonal contraception, must be stable on the same method for a minimum of 3 months. 
  • Combined (estrogen and progestogen containing) hormonal contraception; oral, intravaginal or transdermal. 
  • Progestogen-only hormonal contraception: oral, injectable or implantable. 
  • Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) 
  • Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). 
  • Bilateral oophorectomy with or without hysterectomy, total hysterectomy or bilateral salpingectomy, Bilateral tubal occlusion, bilateral tubal ligation, vasectomized male partner at least 6 weeks prior to screening 
• 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) 
•  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? 
• Are you willing to avoid donating blood during the study? 
• Are you willing to fast for approximately 8 hours before certain study visits? (water is allowed) 
• Are you willing and able to sign an informed consent form?