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

Hypertriglyceridemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133210
• Other study ID #: 10-0533
• Status: Completed
• Phase: Phase 1
• First received: May 26, 2010
• Last updated: December 9, 2013
• Start date: January 2011
• Est. completion date: November 2012

Study information

• Verified date: December 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

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

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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No