Study of Oral MD-0727 Administered to Patients With Primary Hypercholesterolemia

Ironwood Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Hypercholesterolemia

Treatments

Drug: MD-0727

Study type

Interventional

Funder types

Industry

Identifiers

NCT00404001

MCP-104-201

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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