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

Phase 1

Completed

• Conditions: Hypertriglyceridemia
• Interventions: Other: placebo; Drug: Maraviroc

• Registration Number: NCT01133210
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

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:

1. Plasma triglyceride concentration

2. Plasma HDL-cholesterol and LDL-cholesterol concentrations

3. Plasma markers of cardiometabolic risk and inflammation

Study Timeline

• Study First Submitted: 2010-05-26
• Study First Submitted QC: 2010-05-26
• Study First Posted: 2010-05-28
• Study Start: 2011-01
• Primary Completion: 2012-08
• Study Completion: 2012-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-09
• Last Update Posted: 2013-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Subjects will receive 12 weeks of treatment with placebo
Maraviroc	Maraviroc	Subjects will receive 12 weeks of treatment with maraviroc (300 mg po bid).

Primary Outcome Measures

Name	Time	Method
effect of Maraviroc on plasma triglyceride concentration	12 weeks	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

Name	Time	Method
Effect of Maraviroc on serum HDL concentration	12 weeks	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 plasma markers of cardiometabolic risk and inflammation	12 weeks	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.
effect of Maraviroc on serum LDL-cholesterol concentration	12 weeks	We will compare pre and post-treatment serum LDL-cholesterol concentrations in subjects receiving a 12 week course of either Maraviroc or placebo.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States