Study of MB07811 in Subjects With Hypercholesterolemia

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00879112
• Other study ID #: MB07811-201
• Status: Withdrawn
• Phase: Phase 2
• First received: April 8, 2009
• Last updated: August 10, 2011
• Start date: April 2009
• Est. completion date: December 2009

Study information

• Verified date: August 2011
• Source: Ligand Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 80
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• MB07811
Oral
• Placebo
Oral

Locations

Country	Name	City	State
United States	Radiant Research	Chicago	Illinois
United States	Research Across America	Dallas	Texas
United States	Coastal Carolina Research Center, Inc.	Goose Creek	South Carolina
United States	Midwest Institute for Clinical Research	Indianapolis	Indiana
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Commonwealth Biomedical Research	Madisonville	Kentucky
United States	National Clinical Research - Norfolk	Norfolk	Virginia
United States	University Clinical Research	Pembroke Pines	Florida
United States	National Clinical Research	Richmond	Virginia
United States	Scripps Clinic, Clinical Research	San Diego	California
United States	Troy Internal Medicine	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Ligand Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the effects of MB07811 compared to placebo on LDL-C		12-weeks of treatment	No
Secondary	Evaluate the effects of MB07811 on other lipid markers compared to placebo		12 weeks	No
Secondary	Assess the safety and tolerability of MB07811		after 12 weeks of treatment and during off-drug phase	No