Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS
Information source: Aegerion Pharmaceuticals, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperlipidemia
Intervention: AEGR-733 (Drug); placebo (Drug); AEGR-733 and atorvastatin (Drug); AEGR-733 and fenofibrate (Drug); AEGR-733 and ezetimibe (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Aegerion Pharmaceuticals, Inc. Official(s) and/or principal investigator(s):
William Sasiela, PhD, Study Director, Affiliation: Aegerion Pharmaceuticals, Inc.
Summary
To determine safety and effectiveness of low-dose therapeutic AEGR-733 +/- atorvastatin,
ezetimibe or fenofibrate (compared to placebo) on liver fat accumulation measured by Magnetic
Resonance Spectroscopy
Clinical Details
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Low Doses of the MTP-Inhibitor AEGR-733 on Hepatic Fat Accumulation as Measured by Magnetic Resonance Spectroscopy
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percent change from baseline in hepatic fat content at 12 weeks measured by MRS for AEGR-733-5mg compared to placebo.
Secondary outcome: Percent change from baseline in hepatic fat content as measured by MRS between treatment groups.
Detailed description:
The goal within the current development program and this study is to investigate whether
lower doses of AEGR-733 can result in significant reductions in LDL-C and TGs while providing
fewer gastrointestinal adverse events and less hepatic fat accumulation than seen in studies
with higher doses. The potential for atorvastatin, ezetimibe or the PPAR-alpha agonist
(fenofibrate) to ameliorate any hepatic fat accumulation will also be investigated. The
twelve week dosing schedule allows us to demonstrate the longer term effects of lower doses
of MTP-I on hepatic fat accumulation.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. LDL-C between 100 and 190 mg/dL
2. Hepatic fat under 6. 2% per MRS
Exclusion Criteria:
1. Pregnant or lactating females
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
Locations and Contacts
Radiant Research, Santa Rosa, California 95405, United States
Scripps Clinic, San Diego, California 92128, United States
MedStar Research Institute, Washington, District of Columbia 20003, United States
Radiant Research, Chicago, Illinois 60610, United States
University of Iowa, Iowa City, Iowa 52242, United States
LMARC, Louisville, Kentucky 40213, United States
Maine Research Associates, Auburn, Maine 04210, United States
Johns Hopkins, Baltimore, Maryland 21287, United States
Health Trends Research, Baltimore, Maryland 21209, United States
Washington Univ. School of Medicine, St. Louis, Missouri 63110, United States
Sterling Research Group, Cincinnati, Ohio 45219, United States
University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
Baylor College of Medicine, Houston, Texas 77030, United States
dgd Research, San Antonio, Texas 78229, United States
Clinical Trial Network, Houston, Texas 77074, United States
Additional Information
Starting date: October 2007
Ending date: November 2008
Last updated: May 20, 2008
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