Phase 2
N=260
Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS
Hyperlipidemia
Bottom Line
View on ClinicalTrials.gov: NCT00559962 ↗Enrolled (actual)
260
Serious AEs
1.2%
Results posted
Feb 2013
Primary outcome: Primary: Absolute Change From Baseline in Percent Hepatic Fat — 0.03; 4.72 Percent of Hepatic Fat — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AEGR-733 (Drug); placebo (Drug); AEGR-733 and atorvastatin (Drug); AEGR-733 and fenofibrate (Drug); AEGR-733 and ezetimibe (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aegerion Pharmaceuticals, Inc.
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Percent Hepatic Fat |
0.03; 4.95; 4.72; 3.94; 7.86; 3.68 | <0.001 sig |
| SECONDARY Absolute Change From Baseline in Percent Hepatic Fat |
0.03; 4.95; 4.72; 3.94; 7.86; 3.68 | <0.001 sig |
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
Eligibility Criteria
Inclusion Criteria
- LDL-C between 100 and 190 mg/dL
- Hepatic fat under 6.2% per MRS
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00559962). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.