Study of MB07811 in Subjects With Hypercholesterolemia

• Status: Withdrawn
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 2 randomized, placebo controlled study assessing the efficacy, safety, and tolerability of MB07811 given orally to subjects with primary hypercholesterolemia for 12 weeks followed by a 6-week off drug phase.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ligand Pharmaceuticals

Criteria

Inclusion Criteria:

• Body mass index (BMI) 18.50 - 40 kg/m2 inclusive at screening;

• Fasting serum LDL-C ≥145 mg/dL at both Q2 and Q3 visits;

• Fasting mean serum LDL-C <220 mg/dL from Q2 and Q3;

Exclusion Criteria:

• History of clinically significant cardiovascular disease

• Uncontrolled hypertension

• Significant sinus bradycardia defined as <40 beats per minute (bpm);

• Personal or family history of clinically significant unexplained syncope, near-syncope or unexplained sudden death or QT syndrome;

• Holter monitor report demonstrating any abnormality that is clinically significant, including but not limited to PVC frequency > 1 per minute, any alert criteria or any other condition that requires further evaluation;

• History of clinical significant arrhythmia;

• Resting 12-lead ECG showing QTc >450 msec or <360 msec (males or females), any tachyarrhythmia or morphology change, or any other clinically significant abnormality;

• Any other cardiovascular event requiring hospitalization;

• History or presence of thyroid disorder or other metabolic/endocrine disorder that affects lipids or glucose; Exceptions: polycystic ovarian syndrome (PCOS) and impaired glucose tolerance (IGT) are allowed.

• Liver disease, gallbladder disease, Gilbert's syndrome, biopsy-proven nonalcoholic steatohepatitis (NASH), positive serology for hepatitis B surface antigen (HBsAg) or hepatitis C antibodies; Exceptions: gallbladder disease treated with cholecystectomy

• History of human immunodeficiency virus (HIV);

• Subjects with a prior history of malignancy in past 5 years;Exceptions: Subjects with previous history of basal or squamous cell carcinoma of the skin, or cervical cancer in situ are allowed if successfully treated;

• History of myopathy, including any history of statin-induced myopathy;

• History of intolerance to statins (e.g., myalgias, elevated liver tests);

• History of clinically significant psychiatric disorders, including but not limited to bipolar disorder, major depressive disorder, psychosis;

• Renal dysfunction;

• Alcohol and/or drug abuse within 12 months prior to screening;