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

The Washington University

Status and phase: Completed; Phase 1

Conditions: Hypertriglyceridemia

Treatments: Other: placebo; Drug: Maraviroc

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01133210

10-0533

Details and patient eligibility

About

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

Full 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

Enrollment: 27 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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27 participants in 2 patient groups, including a placebo group

Maraviroc

Experimental group

Description:

Subjects will receive 12 weeks of treatment with maraviroc (300 mg po bid).

Treatment:

Drug: Maraviroc

Placebo

Placebo Comparator group

Description:

Subjects will receive 12 weeks of treatment with placebo

Treatment:

Other: placebo