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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01133210
First received: May 26, 2010
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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

Condition Intervention Phase
Hypertriglyceridemia
Drug: Maraviroc
Other: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • effect of Maraviroc on plasma triglyceride concentration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Effect of Maraviroc on serum HDL concentration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 serum LDL-cholesterol concentration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    We will compare pre and post-treatment serum LDL-cholesterol concentrations in subjects receiving a 12 week course of either Maraviroc or placebo.

  • Effect of Maraviroc on plasma markers of cardiometabolic risk and inflammation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 27
Study Start Date: January 2011
Study Completion Date: November 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Maraviroc
Subjects will receive 12 weeks of treatment with maraviroc (300 mg po bid).
Drug: Maraviroc
dosage will be a 300mg Maraviroc pill twice a day for 12 weeks
Other Names:
  • Selzentry
  • Celsentri
Placebo Comparator: Placebo
Subjects will receive 12 weeks of treatment with placebo
Other: placebo
subjects will be given placebo pills with instructions to take one pill twice a day for 12 weeks.
Other Name: control

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
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133210

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Pfizer
Investigators
Principal Investigator: Samuel Klein, M.D. Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01133210     History of Changes
Other Study ID Numbers: 10-0533
Study First Received: May 26, 2010
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
hypertriglyceridemia
triglyceride
cholesterol
Maraviroc

Additional relevant MeSH terms:
Hypertriglyceridemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014