Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aegerion Pharmaceuticals, Inc.
• Treatments: Atorvastatin; Atorvastatin Calcium; Ezetimibe; Fenofibrate

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