Hypercholesterolemia
Conditions
Keywords
Microbia, MD-0727, Primary Hypercholesterolemia, Hypercholesterolemia, Hyperlipidemia, Dyslipidemia, Cholesterol, LDL
Brief summary
The primary objectives of this study are to evaluate the safety of MD-0727 in patients with primary hypercholesterolemia and to determine the low density lipoprotein cholesterol (LDL-C) lowering effect and dose-response of MD-0727 in patients with primary hypercholesterolemia.
Interventions
DRUGMD-0727
Sponsors
Ironwood Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is male or non-pregnant, non-breastfeeding female, at least 18 years of age * Patient must agree to use contraception and/or birth control if sexually active * Patient may not be on lipid-lowering therapies at least 6 weeks prior to study and must have a fasting LDL-C 130 mg/dl or greater at Screening * Patient must have an average of two fasting LDL-C measures greater than/equal to 130 mg/dl but less than/equal to 210 mg/dl with a difference in the two measures less than/equal to 15%. Patient may not have a fasting serum triglyceride less than 300 mg/dl during Pre-treatment Period * Patient's BMI must be greater than/equal to 18.5 but less than 35.0 at Screening * Patient must complete a physical exam, 12-lead ECG, and other laboratory tests (including pregnancy test) with no clinically-significant findings prior to the first dose of study medication * Patient agrees to comply with the TLC diet * Patient completes a 6-week washout of previous lipid-lowering medication including over-the-counter products
Exclusion criteria
* Patient has a medical condition that is prohibited per protocol or a condition that the Investigator believes may limit the patient's ability to participate in the study * Patient has a TSH level \>1.5 X the upper limit of normal * Patient has history of cardiovascular or coronary artery disease, uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins, or patient has history of NYHA Class III or IV congestive heart failure * Patient is diabetic or presents with fasting blood glucose greater than/equal to 126 mg/dl at any time prior to randomization * Patient has uncontrolled hypertension with a systolic blood pressure greater than/equal to 180 mm Hg or diastolic blood pressure greater than/equal to 110 mmg Hg at two study visits prior to the first dose of study medication * Patient has a 10-year CHD risk of \> 20% * Patient has ALT or AST \> 1.5 X the upper limit of normal prior to randomization * Patient has a history of alcohol or drug abuse within 12 months of Screening * Patient has used a prohibited medication (per protocol) during the 14-day Pre-treatment Visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Low density lipoprotein cholesterol (LDL-C) | — |
Secondary
| Measure | Time frame |
|---|---|
| Total cholesterol | — |
Countries
United States
Outcome results
None listed