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Study of MB07811 in Subjects With Hypercholesterolemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00879112
Recruitment Status : Withdrawn (Study terminated prior to initiation)
First Posted : April 9, 2009
Last Update Posted : August 12, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: MB07811 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of MB07811 for 12 Weeks Followed by a 6-Week Off Drug Phase in Subjects With Primary Hypercholesterolemia
Study Start Date : April 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
MB07811 Cohort 1
Drug: MB07811

Experimental: 2
MB07811 Cohort 2
Drug: MB07811

Experimental: 3
MB07811 Cohort 3
Drug: MB07811

Placebo Comparator: 4
Cohort 4
Drug: Placebo

Primary Outcome Measures :
  1. Evaluate the effects of MB07811 compared to placebo on LDL-C [ Time Frame: 12-weeks of treatment ]

Secondary Outcome Measures :
  1. Evaluate the effects of MB07811 on other lipid markers compared to placebo [ Time Frame: 12 weeks ]
  2. Assess the safety and tolerability of MB07811 [ Time Frame: after 12 weeks of treatment and during off-drug phase ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00879112

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United States, California
Scripps Clinic, Clinical Research
San Diego, California, United States, 92128
United States, Florida
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
University Clinical Research
Pembroke Pines, Florida, United States, 33024
United States, Illinois
Radiant Research
Chicago, Illinois, United States, 60654
United States, Indiana
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Commonwealth Biomedical Research
Madisonville, Kentucky, United States, 42431
United States, Michigan
Troy Internal Medicine
Troy, Michigan, United States, 48098
United States, South Carolina
Coastal Carolina Research Center, Inc.
Goose Creek, South Carolina, United States, 29445
United States, Texas
Research Across America
Dallas, Texas, United States, 75234
United States, Virginia
National Clinical Research - Norfolk
Norfolk, Virginia, United States, 23502
National Clinical Research
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
Ligand Pharmaceuticals
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Study Director: Trish Novak, Ph.D. Metabasis Therapeutics, Inc.

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Responsible Party: Director, Project Management, Ligand Pharmaceuticals Identifier: NCT00879112     History of Changes
Other Study ID Numbers: MB07811-201
First Posted: April 9, 2009    Key Record Dates
Last Update Posted: August 12, 2011
Last Verified: August 2011
Keywords provided by Ligand Pharmaceuticals:
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases