Basic Criteria
Age Requirements:
- Must be between 18 and 64 years old
- Must have a Primary Care Physician to process medical record requests
Current Conditions:
- Must have cholesterol levels of 100 mg/dL or higher on fasting blood test
- Must either be new to cholesterol medications OR have been off specific cholesterol treatments for required time periods
- Cannot be planning to start any cholesterol medications during screening
Answers Must Be NO
- Are you currently pregnant, trying to get pregnant, or breastfeeding?
- Do you routinely drink more than 2 alcoholic drinks per day?
- Have you had problems with drug abuse in the past year or are you currently using illegal drugs?
- Do you have uncontrolled high blood pressure with readings consistently above 160/100 mmHg despite medication?
- If diabetic, is your A1C ≥9.0%?
- Are you currently taking any of these medications: cyclosporine, certain antiviral medications, gemfibrozil, regorafenib, darolutamide, enasidenib, teriflunomide, capmatinib, fostamatinib, febuxostat, tafamadis, cholestyramine, colchicine, ticagrelor, warfarin, or high-dose niacin (1 gram or more daily)?
- Are you currently in another research study or have you been in one within the past 3 months?
- Are you unwilling to take statin medications, or have you had serious side effects or allergic reactions to statin medications in the past?
- Have you had a heart attack, stroke, coronary procedures, or other major cardiovascular events in the past 3 months?
- Are you currently receiving chemotherapy for cancer or have you had any cancer (except skin cancer) in the past 3 years?
- Do you have active liver disease or have recent blood tests shown liver problems?
- Have you ever had myopathy, myositis, rhabdomyolysis (serious muscle breakdown), or unexplained muscle pain and weakness from medications?
- Do you have advanced heart failure that severely limits your daily activities or have you been hospitalized for heart failure in the past 3 months?
- Do you have severe kidney disease requiring dialysis or have you been told your kidney function is severely reduced (eGFR less than 30, typically stage 4 &5 )?
- Have you had LDL apheresis treatments (a procedure to remove cholesterol from blood) in the past 3 months or are you planning to start these treatments?
- Have you been told you have high triglycerides (above 400 mg/dL if known)?
- Are you currently engaged in vigorous exercise training such as marathon training or bodybuilding or plan to do so?
- In the past 3 months, have you experienced any recurrent vomiting, inflammatory bowel disease with ongoing symptoms, chronic intestinal disease accompanied by a disturbance in digestion absorption, or have a history of extensive resection of the upper GI tract?
- Have you had elevated creatine kinase levels (a muscle enzyme) above 3 times the normal limit, or a history of unexplained muscle enzyme elevations?
- Have you had an organ transplant or do you have major heart, lung, or abdominal surgery planned in the next 5 months?
- Do you have HIV infection or AIDS?
- Have you ever been diagnosed with nephrotic syndrome (a serious kidney condition causing protein loss)?
- Do you identify as being of Asian descent or heritage?
- Do you have a personal or family history of hereditary muscular disorders or genetic muscle diseases?
- Have you been diagnosed with homozygous familial hypercholesterolemia (a severe genetic form of high cholesterol) or other rare inherited cholesterol disorders?
Answers Must Be YES
- Do you have a primary care physician?
- Are you willing and able to follow fasting instructions (no food or drink except water for 8+ hours before dosing and clinic visits)?
- If you are a woman who could become pregnant, are you using highly effective birth control (birth control pills, IUD, implant, sexual abstinence, or other highly effective method) and willing to continue for 8 weeks after the study medication?
- If male, are you willing to use condoms during the study and continue for 8 weeks after study medication?
- Are you willing to commit to taking daily study medication and attending all required visits over approximately 6 months?
Compensation may be available for time and travel
Insurance is not required
PLEASE NOTE: If you do not see an available appointment, please call 210-714-0067 for availability
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