Back to resultsEffect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)
Primary Purpose
Hypertriglyceridemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Maraviroc
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertriglyceridemia focused on measuring hypertriglyceridemia, triglyceride, cholesterol, Maraviroc
Eligibility Criteria
Inclusion Criteria:
- obese (body mass index (BMI) between 30 and 45.9)
- increased plasma triglyceride concentrations (150-400 mg/dL)
Exclusion Criteria:
- active or previous infection with hepatitis B or C
- history of alcohol abuse
- current alcohol consumption (>20g/day)
- severe hypertriglyceridemia (>400 mg/dL)
- active peptic ulcer disease
- diabetes
- pregnant or lactating
- take statins, fibrates, niacin, moderate to strong Cyp3A4 inhibitors or inducers, or any other medication that might confound interpretation of the study results will be excluded.
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Maraviroc
Placebo
Arm Description
Subjects will receive 12 weeks of treatment with maraviroc (300 mg po bid).
Subjects will receive 12 weeks of treatment with placebo
Outcomes
Primary Outcome Measures
effect of Maraviroc on plasma triglyceride concentration
We will compare pre and post-treatment serum triglyceride concentrations in subjects receiving a 12 week course of either Maraviroc or placebo.
Secondary Outcome Measures
Effect of Maraviroc on serum HDL concentration
We will compare pre and post-treatment serum HDL concentrations in subjects receiving a 12 week course of either Maraviroc or placebo.
effect of Maraviroc on serum LDL-cholesterol concentration
We will compare pre and post-treatment serum LDL-cholesterol concentrations in subjects receiving a 12 week course of either Maraviroc or placebo.
Effect of Maraviroc on plasma markers of cardiometabolic risk and inflammation
We will compare pre and post-treatment plasma concentrations of C-reactive protein and InterLeukin-6 in subjects receiving a 12 week course of either Maraviroc or placebo.
Full Information
NCT ID
NCT01133210
First Posted
May 26, 2010
Last Updated
December 9, 2013
Sponsor
Washington University School of Medicine
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT01133210
Brief Title
Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)
Official Title
Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the effect of maraviroc therapy in obese insulin resistant subjects on:
Plasma triglyceride concentration
Plasma HDL-cholesterol and LDL-cholesterol concentrations
Plasma markers of cardiometabolic risk and inflammation
Detailed Description
The purpose of this study is to determine, in obese insulin resistant subjects, the effect of maraviroc therapy, a selective antagonist of the human chemokine receptor CCR5, on:
Plasma triglyceride concentration
Plasma HDL-cholesterol and LDL-cholesterol concentrations
Plasma markers of cardiometabolic risk and inflammation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia
Keywords
hypertriglyceridemia, triglyceride, cholesterol, Maraviroc
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Maraviroc
Arm Type
Experimental
Arm Description
Subjects will receive 12 weeks of treatment with maraviroc (300 mg po bid).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive 12 weeks of treatment with placebo
Intervention Type
Drug
Intervention Name(s)
Maraviroc
Other Intervention Name(s)
Selzentry, Celsentri
Intervention Description
dosage will be a 300mg Maraviroc pill twice a day for 12 weeks
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
control
Intervention Description
subjects will be given placebo pills with instructions to take one pill twice a day for 12 weeks.
Primary Outcome Measure Information:
Title
effect of Maraviroc on plasma triglyceride concentration
Description
We will compare pre and post-treatment serum triglyceride concentrations in subjects receiving a 12 week course of either Maraviroc or placebo.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Effect of Maraviroc on serum HDL concentration
Description
We will compare pre and post-treatment serum HDL concentrations in subjects receiving a 12 week course of either Maraviroc or placebo.
Time Frame
12 weeks
Title
effect of Maraviroc on serum LDL-cholesterol concentration
Description
We will compare pre and post-treatment serum LDL-cholesterol concentrations in subjects receiving a 12 week course of either Maraviroc or placebo.
Time Frame
12 weeks
Title
Effect of Maraviroc on plasma markers of cardiometabolic risk and inflammation
Description
We will compare pre and post-treatment plasma concentrations of C-reactive protein and InterLeukin-6 in subjects receiving a 12 week course of either Maraviroc or placebo.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
obese (body mass index (BMI) between 30 and 45.9)
increased plasma triglyceride concentrations (150-400 mg/dL)
Exclusion Criteria:
active or previous infection with hepatitis B or C
history of alcohol abuse
current alcohol consumption (>20g/day)
severe hypertriglyceridemia (>400 mg/dL)
active peptic ulcer disease
diabetes
pregnant or lactating
take statins, fibrates, niacin, moderate to strong Cyp3A4 inhibitors or inducers, or any other medication that might confound interpretation of the study results will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Klein, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)
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