Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS
NCT ID: NCT00559962
Last Updated: 2018-02-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
260 participants
INTERVENTIONAL
2007-10-31
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Placebo
placebo
3 capsules each evening for each 4-week period
2
2.5 mg AEGR-733
AEGR-733
3 capsules each evening for each 4-week period
3
5 mg AEGR-733
AEGR-733
3 capsules each evening for each 4-week period
4
7.5 mg AEGR-733
AEGR-733
3 capsules each evening for each 4-week period
5
10 mg AEGR-733
AEGR-733
3 capsules each evening for each 4-week period
6
5 mg AEGR-733 + 20 mg atorvastatin
AEGR-733 and atorvastatin
3 capsules each evening for each 4-week period
7
5 mg AEGR-733 + 145 mg fenofibrate
AEGR-733 and fenofibrate
3 capsules each evening for each 4-week period
8
5 mg AEGR-733 + 10 mg ezetimibe
AEGR-733 and ezetimibe
3 capsules each evening for each 4-week period
Interventions
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AEGR-733
3 capsules each evening for each 4-week period
placebo
3 capsules each evening for each 4-week period
AEGR-733
3 capsules each evening for each 4-week period
AEGR-733
3 capsules each evening for each 4-week period
AEGR-733
3 capsules each evening for each 4-week period
AEGR-733 and atorvastatin
3 capsules each evening for each 4-week period
AEGR-733 and fenofibrate
3 capsules each evening for each 4-week period
AEGR-733 and ezetimibe
3 capsules each evening for each 4-week period
Eligibility Criteria
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Inclusion Criteria
2. Hepatic fat under 6.2% per MRS
Exclusion Criteria
2. Uncontrolled hypertension \>180/95 mmHg
3. Chronic renal insufficiency - serum creatinine \>2.5 mg/dL at screen
4. Liver disease; i.e., hepatitis, cirrhosis
5. Major surgery within 3 months of screen
6. Cardiac insufficiency
7. Hx of malignancy other than basal or squamous cell within past 5 yrs
8. Participation in any investigational drug study within 6 wks of screen
9. Prior exposure to AEGR-733 in past 12 months
10. Serious or unstable medical or psychological conditions
11. More than one alcoholic drink per day
12. Regular consumption of grapefruit juice or meds known to be metabolized by CYP 3A4
13. Currently taking corticosteroids
14. Other lipid-lowering meds (washout permitted)
15. Fish oil, niacin grater than 200 mg/day and herbal weight loss products (washout permitted)
16. Acute CVD or event within previous 6 months
17. Diabetes Mellitus
18. Hepatitis B or C
19. Medicated COPD
20. Idiopathic pulmonary fibrosis
21. G.I. disorders that cause chronic diarrhea
22. Fasting triglycerides =/\> 400 mg/dL
23. Body Mass Index \> 35kg/m2
18 Years
70 Years
ALL
No
Sponsors
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Aegerion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Aegerion Pharmaceuticals
Principal Investigators
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William Sasiela, PhD
Role: STUDY_DIRECTOR
Aegerion Pharmaceuticals, Inc.
Locations
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Scripps Clinic
San Diego, California, United States
Radiant Research
Santa Rosa, California, United States
MedStar Research Institute
Washington D.C., District of Columbia, United States
Radiant Research
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
LMARC
Louisville, Kentucky, United States
Maine Research Associates
Auburn, Maine, United States
Health Trends Research
Baltimore, Maryland, United States
Johns Hopkins
Baltimore, Maryland, United States
Washington Univ. School of Medicine
St Louis, Missouri, United States
Sterling Research Group
Cincinnati, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Clinical Trial Network
Houston, Texas, United States
dgd Research
San Antonio, Texas, United States
Countries
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Other Identifiers
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AEGR-733-004
Identifier Type: -
Identifier Source: org_study_id
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