Study of MB07811 in Subjects With Hypercholesterolemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

MB07811 Cohort 1

Group Type EXPERIMENTAL

MB07811

Intervention Type DRUG

Oral

2

MB07811 Cohort 2

Group Type EXPERIMENTAL

MB07811

Intervention Type DRUG

Oral

3

MB07811 Cohort 3

Group Type EXPERIMENTAL

MB07811

Intervention Type DRUG

Oral

4

Cohort 4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral

Interventions

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MB07811

Oral

Intervention Type DRUG

Placebo

Oral

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No