Study of MB07811 in Subjects With Hypercholesterolemia

This study has been withdrawn prior to enrollment.
(Study terminated prior to initiation)
Sponsor:
Information provided by:
Ligand Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00879112
First received: April 8, 2009
Last updated: August 10, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Hypercholesterolemia
Drug: MB07811
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Ligand Pharmaceuticals:

Primary Outcome Measures:
  • Evaluate the effects of MB07811 compared to placebo on LDL-C [ Time Frame: 12-weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the effects of MB07811 on other lipid markers compared to placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Assess the safety and tolerability of MB07811 [ Time Frame: after 12 weeks of treatment and during off-drug phase ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: April 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MB07811 Cohort 1
Drug: MB07811
Oral
Experimental: 2
MB07811 Cohort 2
Drug: MB07811
Oral
Experimental: 3
MB07811 Cohort 3
Drug: MB07811
Oral
Placebo Comparator: 4
Cohort 4
Drug: Placebo
Oral

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00879112

Locations
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
Investigators
Study Director: Trish Novak, Ph.D. Metabasis Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Director, Project Management, Ligand Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00879112     History of Changes
Other Study ID Numbers: MB07811-201
Study First Received: April 8, 2009
Last Updated: August 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Ligand Pharmaceuticals:
Hyperlipidemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 20, 2014