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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hyperlipidemia

In brief

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

Key facts

Study ID

NCT00559962

Run by

Aegerion Pharmaceuticals, Inc.

People needed

260

Starts

2007-10-01

Expected to finish

2008-11-01

Last updated by the study team

2018-02-23

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• LDL-C between 100 and 190 mg/dL
• Hepatic fat under 6.2% per MRS

You may not qualify if…

• Pregnant or lactating females
• Uncontrolled hypertension >180/95 mmHg
• Chronic renal insufficiency - serum creatinine >2.5 mg/dL at screen
• Liver disease; i.e., hepatitis, cirrhosis
• Major surgery within 3 months of screen
• Cardiac insufficiency
• Hx of malignancy other than basal or squamous cell within past 5 yrs
• Participation in any investigational drug study within 6 wks of screen
• Prior exposure to AEGR-733 in past 12 months
• Serious or unstable medical or psychological conditions
• More than one alcoholic drink per day
• Regular consumption of grapefruit juice or meds known to be metabolized by CYP 3A4
• Currently taking corticosteroids
• Other lipid-lowering meds (washout permitted)
• Fish oil, niacin grater than 200 mg/day and herbal weight loss products (washout permitted)
• Acute CVD or event within previous 6 months
• Diabetes Mellitus
• Hepatitis B or C
• Medicated COPD
• Idiopathic pulmonary fibrosis
• G.I. disorders that cause chronic diarrhea
• Fasting triglycerides =/> 400 mg/dL
• Body Mass Index > 35kg/m2

Where it is running

• 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

Full record on ClinicalTrials.gov

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