Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)

Study Overview
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Brief Summary
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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
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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

Official Title
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Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Drug: Maraviroc
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maraviroc<br>Subjects will receive 12 weeks of treatment with maraviroc (300 mg po bid). | Drug: Maraviroc<br>* dosage will be a 300mg Maraviroc pill twice a day for 12 weeks<br>* Other names: Celsentri;|
| Placebo Comparator: Placebo<br>Subjects will receive 12 weeks of treatment with placebo | Other: placebo<br>* subjects will be given placebo pills with instructions to take one pill twice a day for 12 weeks.<br>* Other names: control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 
| 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. | 12 weeks | 
| 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertriglyceridemia, triglyceride, cholesterol, Maraviroc