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

NCT01133210

Last updated date
Study Location
Washington University School of Medicine
St. Louis, Missouri, 63110, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertriglyceridemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-64 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- obese (body mass index (BMI) between 30 and 45.9)

- increased plasma triglyceride concentrations (150-400 mg/dL)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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HypertriglyceridemiaEffect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)
NCT01133210
  1. St. Louis, Missouri
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)
Official Title  ICMJE Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Hypertriglyceridemia
Intervention  ICMJE
  • Drug: Maraviroc
    dosage will be a 300mg Maraviroc pill twice a day for 12 weeks
    Other Names:
    • Selzentry
    • Celsentri
  • Other: placebo
    subjects will be given placebo pills with instructions to take one pill twice a day for 12 weeks.
    Other Name: control
Study Arms  ICMJE
  • Experimental: Maraviroc
    Subjects will receive 12 weeks of treatment with maraviroc (300 mg po bid).
    Intervention: Drug: Maraviroc
  • Placebo Comparator: Placebo
    Subjects will receive 12 weeks of treatment with placebo
    Intervention: Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2013)
27
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2010)
44
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01133210
Other Study ID Numbers  ICMJE 10-0533
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Samuel Klein, M.D.Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP