Dyslipidemia Self-Scheduler

Basic Criteria 

• Age: 18-70 years old 
• Gender: Men and women (women must be on an approved highly effective form of contraception, postmenopausal or surgically sterilized)
• BMI: Greater than 18
• Availability: Must stay at research facility 2 separate overnight visits (2 days each) and attend 1 follow-up visit. Must also be okay with taking an oral medication daily at home.
• Lp(a) Value: Greater than 70 mg/dL

Exclusion Questions – Answers Must Be NO 

• For men: Are you unwilling or unable to use appropriate contraception and avoid fathering a child for 3 months after the study? 

• Do you drink more than 2 cups of coffee per day or consume excessive amounts of caffeine?

• Do you have a history of drug or alcohol abuse, or do you drink alcohol heavily?  

• Do you have uncontrolled blood pressure? (Uncontrolled = not stable on medication and >160/90)?

• Do you have poorly controlled diabetes? (HbA1c greater than 10%)

• Do you use or have you ever used any of the following: Inclisiran, Evolocumab or Alirocumab?

• ave you used Lomitapide within the last 12 months?

• Do you currently smoke or use any cigarettes, use e-cigarettes, vape, or use any nicotine products in the last 3 months?

• Have you used any medications that affect the liver in the past 3 weeks? (Such as St. John’s Wort)

• Do you have any known bleeding disorders, blood clotting problems, or take blood thinners?

• Have you been diagnosed with any, liver, kidney, stomach, or intestinal diseases?

• Have you been hospitalized, had surgery, or been seriously ill within the past month?

• Do you have a personal or family history of heart rhythm problems, including long QT syndrome?

• Do you currently have HIV, hepatitis B, or hepatitis C?

• Have you donated plasma within the past month? 

• Have you donated or lost more than 500 mL (one pint) of blood within the past 3 months? 

• Do you have any medical dietary restrictions or unable to comply with meals provided at the clinic? 

• Are you in detention, a protected adult under guardianship, trusteeship, or committed to an institution by governmental or juridical order? 

• Do you have kidney problems, or have you been told your kidney function is reduced? 

• Are you allergic to any medications or have you had severe allergic reactions? 

• Do you currently use any of the following enzyme inducers: Phenytoin, Carbamazepine, Phenobarbital, Primidone, Rifampin, St. John’s Wort?

Answers Must Be YES 

• Are you currently receiving moderate or high-intensity statin therapy? Have you been stable for > 2 months? (stable = no changes in dosages/medications)  

• Do you currently have any of the following medical conditions: Coronary Artery Disease, Stroke, Peripheral Artery Disease , Moderate to high risk of having a heart or blood vessel event caused by plaque buildup in the arteries, Hypertension, Hypercholesterolemia, Type 2 Diabetes? 

• Are you willing to avoid alcohol, smoking, and follow dietary restrictions during the study? 

• Are you able to fast overnight before taking the study medication when required? 

• If female of childbearing potential, do you meet one of the following requirements? 

• • Utilizing a highly effective non-hormonal contraception  

• • Must be stable on birth control for at least 1 month prior  

• If female of non-childbearing potential, do you meet one of the following requirements? 

• • Postmenopausal defined as no cycle for 12 months without an alternative medical cause

• • Documented: hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks prior to first visit

• Are you willing to refrain from consuming poppy seeds, red wine, Seville oranges, grapefruit, or grapefruit juice, pomelos, exotic citrus fruits, grapefruit hybrids, citrus fruit juices, liquorice, or quinine at certain times during the study? 

• If male, are you willing to refrain from sperm donation throughout the study? 

Additional Criteria May Apply

Please Note: Your first visit will be a prescreening appointment to see if you may be eligible for the study. If your results fall within the study’s requirements, we will contact you to schedule a follow-up screening visit.

• If you do not see an available appointment, please call (210) 714-0067 for availability.

• Transportation may be available. Call (210) 714-0067. 

• Compensation up to $2,550, travel is reimbursed up to $65.00 with receipts