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

Washington University School of Medicine27 enrolled

Overview

The purpose of this study is to determine the effect of maraviroc therapy in obese insulin resistant subjects on: 1. Plasma triglyceride concentration 2. Plasma HDL-cholesterol and LDL-cholesterol concentrations 3. Plasma markers of cardiometabolic risk and inflammation

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: 1. Plasma triglyceride concentration 2. Plasma HDL-cholesterol and LDL-cholesterol concentrations 3. Plasma markers of cardiometabolic risk and inflammation

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hypertriglyceridemia

Interventions

MaravirocDRUG

dosage will be a 300mg Maraviroc pill twice a day for 12 weeks

placeboOTHER

subjects will be given placebo pills with instructions to take one pill twice a day for 12 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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.

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.