Study of MB07811 in Subjects With Hypercholesterolemia

NCT00879112 | Withdrawn Phase 2

• 1 other identifier: MB07811-201
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 11

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.

Conditions

Hypercholesterolemia

Keywords

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

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

  12-weeks of treatment

Secondary Outcomes (2)

• Evaluate the effects of MB07811 on other lipid markers compared to placebo

  12 weeks

• Assess the safety and tolerability of MB07811

  after 12 weeks of treatment and during off-drug phase

Study Arms (4)

1

EXPERIMENTAL

MB07811 Cohort 1

Drug: MB07811

2

EXPERIMENTAL

MB07811 Cohort 2

Drug: MB07811

3

EXPERIMENTAL

MB07811 Cohort 3

Drug: MB07811

4

PLACEBO COMPARATOR

Cohort 4

Drug: Placebo

Interventions

MB07811 DRUG

Oral

1; 2; 3

Placebo DRUG

Oral

4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ligand Pharmaceuticals: lead

Study Sites (11)

Scripps Clinic, Clinical Research

San Diego, California, 92128, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

University Clinical Research

Pembroke Pines, Florida, 33024, United States

Location

Radiant Research

Chicago, Illinois, 60654, United States

Location

Midwest Institute for Clinical Research

Indianapolis, Indiana, 46260, United States

Location

Commonwealth Biomedical Research

Madisonville, Kentucky, 42431, United States

Location

Troy Internal Medicine

Troy, Michigan, 48098, United States

Location

Coastal Carolina Research Center, Inc.

Goose Creek, South Carolina, 29445, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

National Clinical Research - Norfolk

Norfolk, Virginia, 23502, United States

Location

National Clinical Research

Richmond, Virginia, 23294, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia; Hyperlipidemias

Interventions

2-((3,5-dimethyl-4-(4'-hydroxy-3'-isopropylbenzyl)phenoxy)methyl)-4-(3-chlorophenyl)-2-oxido(1,3,2)dioxaphosphonane

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Trish Novak, Ph.D.

  Metabasis Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 8, 2009
• First Posted: April 9, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 12, 2011

Record last verified: 2011-08

Locations

US (11)