Study of MB07811 in Subjects With Hypercholesterolemia

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT00879112

Run by

Ligand Pharmaceuticals

People needed

80

Starts

2009-04-01

Expected to finish

2009-12-01

Last updated by the study team

2011-08-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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;

Where it is running

• Scripps Clinic, Clinical Research — San Diego, California, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• University Clinical Research — Pembroke Pines, Florida, United States
• Radiant Research — Chicago, Illinois, United States
• Midwest Institute for Clinical Research — Indianapolis, Indiana, United States
• Commonwealth Biomedical Research — Madisonville, Kentucky, United States
• Troy Internal Medicine — Troy, Michigan, United States
• Coastal Carolina Research Center, Inc. — Goose Creek, South Carolina, United States
• Research Across America — Dallas, Texas, United States
• National Clinical Research - Norfolk — Norfolk, Virginia, United States
• National Clinical Research — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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