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

NCT01133210 | Completed Phase 1 DMC

• 1 other identifier: 10-0533
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect of maraviroc therapy in obese insulin resistant subjects on:

1. 1.Plasma triglyceride concentration
2. 2.Plasma HDL-cholesterol and LDL-cholesterol concentrations
3. 3.Plasma markers of cardiometabolic risk and inflammation

Conditions

Hypertriglyceridemia

Keywords

hypertriglyceridemia; triglyceride; cholesterol; Maraviroc

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Effect of Maraviroc on serum HDL concentration

  12 weeks

• effect of Maraviroc on serum LDL-cholesterol concentration

  12 weeks

• Effect of Maraviroc on plasma markers of cardiometabolic risk and inflammation

  12 weeks

Study Arms (2)

Maraviroc

EXPERIMENTAL

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

Drug: Maraviroc

Placebo

PLACEBO COMPARATOR

Subjects will receive 12 weeks of treatment with placebo

Other: placebo

Interventions

Maraviroc DRUG

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

Also known as: Selzentry, Celsentri

Maraviroc

placebo OTHER

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

Also known as: control

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• obese (body mass index (BMI) between 30 and 45.9)
• increased plasma triglyceride concentrations (150-400 mg/dL)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Pfizer: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

Maraviroc

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Samuel Klein, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 28, 2010
• Study Start: January 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 10, 2013

Record last verified: 2013-12

Locations

US (1)