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

Hyperlipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559962
• Other study ID #: AEGR-733-004
• Status: Completed
• Phase: Phase 2
• First received: November 15, 2007
• Last updated: February 21, 2018
• Start date: October 2007
• Est. completion date: November 2008

Study information

• Verified date: February 2018
• Source: Aegerion Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Maine Research Associates	Auburn	Maine
United States	Health Trends Research	Baltimore	Maryland
United States	Johns Hopkins	Baltimore	Maryland
United States	Radiant Research	Chicago	Illinois
United States	Sterling Research Group	Cincinnati	Ohio
United States	Baylor College of Medicine	Houston	Texas
United States	Clinical Trial Network	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	LMARC	Louisville	Kentucky
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Washington Univ. School of Medicine	Saint Louis	Missouri
United States	dgd Research	San Antonio	Texas
United States	Scripps Clinic	San Diego	California
United States	Radiant Research	Santa Rosa	California
United States	MedStar Research Institute	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Aegerion Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change From Baseline in Percent Hepatic Fat	Absolute change from Baseline in percent hepatic fat	Baseline and 12 weeks on study drug
Secondary	Absolute Change From Baseline in Percent Hepatic Fat	Absolute change from Baseline in percent hepatic fat	Baseline and 12 weeks on study drug