Study of MB07811 in Subjects With Hypercholesterolemia
- Registration Number
- NCT00879112
- Lead Sponsor
- Ligand Pharmaceuticals
- Brief 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.
- Detailed Description
This is an outpatient, Phase 2, multicenter, double-blind, placebo-controlled, randomized, parallel-group study assessing the efficacy, safety, and tolerability of MB07811 given orally to subjects with primary hypercholesterolemia for 12 weeks. There will be a 3- to 6-week screening/run-in period, including washout of any lipid-modifying therapies (as needed) prior to randomization. Eligible subjects will be randomized (1:1:1:1) to placebo, or 3 different doses of MB07811 for 12 weeks. After the double-blind treatment phase, all randomized subjects will proceed into a 6-week off-drug phase. Assessments include: laboratory tests, adverse events (AEs), electrocardiograms (ECGs), vitals, and PK samples.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 80
- 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;
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4 Placebo Cohort 4 1 MB07811 MB07811 Cohort 1 3 MB07811 MB07811 Cohort 3 2 MB07811 MB07811 Cohort 2
- Primary Outcome Measures
Name Time Method Evaluate the effects of MB07811 compared to placebo on LDL-C 12-weeks of treatment
- Secondary Outcome Measures
Name Time Method Evaluate the effects of MB07811 on other lipid markers compared to placebo 12 weeks Assess the safety and tolerability of MB07811 after 12 weeks of treatment and during off-drug phase
Trial Locations
- Locations (11)
Troy Internal Medicine
🇺🇸Troy, Michigan, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
University Clinical Research
🇺🇸Pembroke Pines, Florida, United States
Commonwealth Biomedical Research
🇺🇸Madisonville, Kentucky, United States
National Clinical Research
🇺🇸Richmond, Virginia, United States
Midwest Institute for Clinical Research
🇺🇸Indianapolis, Indiana, United States
National Clinical Research - Norfolk
🇺🇸Norfolk, Virginia, United States
Research Across America
🇺🇸Dallas, Texas, United States
Coastal Carolina Research Center, Inc.
🇺🇸Goose Creek, South Carolina, United States
Scripps Clinic, Clinical Research
🇺🇸San Diego, California, United States
Radiant Research
🇺🇸Chicago, Illinois, United States