HypertriglyceridemiaPhase 1NCT01133210
Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)
A Phase 1 study testing Maraviroc in people with Hypertriglyceridemia, run by Washington University School of Medicine at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- Maraviroc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Nov 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- obese (body mass index (BMI) between 30 and 45.9)
- increased plasma triglyceride concentrations (150-400 mg/dL)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
The purpose of this study is to determine the effect of maraviroc therapy in obese insulin resistant subjects on:
- Plasma triglyceride concentration
- Plasma HDL-cholesterol and LDL-cholesterol concentrations
- Plasma markers of cardiometabolic risk and inflammation
Read the 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:
- Plasma triglyceride concentration
- Plasma HDL-cholesterol and LDL-cholesterol concentrations
- Plasma markers of cardiometabolic risk and inflammation
- Conditions
- Hypertriglyceridemia
- Being tested
- Maraviroc, placebo
- Keywords
- hypertriglyceridemia, triglyceride, cholesterol, Maraviroc
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaravirocDrug
Also called Selzentry, Celsentri
dosage will be a 300mg Maraviroc pill twice a day for 12 weeks
placeboOther
Also called control
subjects will be given placebo pills with instructions to take one pill twice a day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Maraviroc | Experimental | Subjects will receive 12 weeks of treatment with maraviroc (300 mg po bid). Receives: Drug: Maraviroc |
| Placebo | Placebo comparator | Subjects will receive 12 weeks of treatment with placebo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (3)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startJan 2011
- Primary completionAug 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Samuel Klein, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133210
- Sponsor's protocol ID
- 10-0533
- Status last verified
- Dec 2013
- First submitted
- 26 May 2010
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)
- ClinicalTrials.gov ID
- NCT01133210
- Acronym / sponsor ID
- 10-0533
- Conditions
- Hypertriglyceridemia
- Keywords
- hypertriglyceridemia, triglyceride, cholesterol, Maraviroc
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jan 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 28 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of maraviroc therapy in obese insulin resistant subjects on:
- Plasma triglyceride concentration
- Plasma HDL-cholesterol and LDL-cholesterol concentrations
- 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:
- Plasma triglyceride concentration
- Plasma HDL-cholesterol and LDL-cholesterol concentrations
- Plasma markers of cardiometabolic risk and inflammation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maraviroc | Experimental | Drug: MaravirocSubjects will receive 12 weeks of treatment with maraviroc (300 mg po bid). |
| Placebo | Placebo comparator | Other: placeboSubjects will receive 12 weeks of treatment with placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- obese (body mass index (BMI) between 30 and 45.9)
- increased plasma triglyceride concentrations (150-400 mg/dL)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MaravirocAlso: Selzentry, Celsentridosage will be a 300mg Maraviroc pill twice a day for 12 weeks | Drug | Maraviroc |
| placeboAlso: controlsubjects will be given placebo pills with instructions to take one pill twice a day for 12 weeks. | Other | Placebo |
Primary outcome
effect of Maraviroc on plasma triglyceride concentration
Time frame: 12 weeks
We will compare pre and post-treatment serum triglyceride concentrations in subjects receiving a 12 week course of either Maraviroc or placebo.
3 secondary outcomes
Effect of Maraviroc on serum HDL concentration
Time frame: 12 weeks
effect of Maraviroc on serum LDL-cholesterol concentration
Time frame: 12 weeks
Effect of Maraviroc on plasma markers of cardiometabolic risk and inflammation
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Klein, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Maraviroc in people with Hypertriglyceridemia, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of Maraviroc on plasma triglyceride concentration (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2013.