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Study of MB07811 in Subjects With Hypercholesterolemia

Primary Purpose

Hypercholesterolemia

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MB07811
Placebo
Sponsored by
Ligand Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Hyperlipidemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Scripps Clinic, Clinical Research
  • Jacksonville Center for Clinical Research
  • University Clinical Research
  • Radiant Research
  • Midwest Institute for Clinical Research
  • Commonwealth Biomedical Research
  • Troy Internal Medicine
  • Coastal Carolina Research Center, Inc.
  • Research Across America
  • National Clinical Research - Norfolk
  • National Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

MB07811 Cohort 1

MB07811 Cohort 2

MB07811 Cohort 3

Cohort 4

Outcomes

Primary Outcome Measures

Evaluate the effects of MB07811 compared to placebo on LDL-C

Secondary Outcome Measures

Evaluate the effects of MB07811 on other lipid markers compared to placebo
Assess the safety and tolerability of MB07811

Full Information

First Posted
April 8, 2009
Last Updated
August 10, 2011
Sponsor
Ligand Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00879112
Brief Title
Study of MB07811 in Subjects With Hypercholesterolemia
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 Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Study terminated prior to initiation
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ligand Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Hyperlipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
MB07811 Cohort 1
Arm Title
2
Arm Type
Experimental
Arm Description
MB07811 Cohort 2
Arm Title
3
Arm Type
Experimental
Arm Description
MB07811 Cohort 3
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Cohort 4
Intervention Type
Drug
Intervention Name(s)
MB07811
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Evaluate the effects of MB07811 compared to placebo on LDL-C
Time Frame
12-weeks of treatment
Secondary Outcome Measure Information:
Title
Evaluate the effects of MB07811 on other lipid markers compared to placebo
Time Frame
12 weeks
Title
Assess the safety and tolerability of MB07811
Time Frame
after 12 weeks of treatment and during off-drug phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trish Novak, Ph.D.
Organizational Affiliation
Metabasis Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Scripps Clinic, Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
University Clinical Research
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Radiant Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
Midwest Institute for Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Commonwealth Biomedical Research
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Troy Internal Medicine
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Coastal Carolina Research Center, Inc.
City
Goose Creek
State/Province
South Carolina
ZIP/Postal Code
29445
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
National Clinical Research - Norfolk
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
National Clinical Research
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States

12. IPD Sharing Statement

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Study of MB07811 in Subjects With Hypercholesterolemia

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