Phase 2 Completed N=260 Randomized Triple-blind Treatment

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

Hyperlipidemia

Source: ClinicalTrials.gov NCT00559962 ↗

Enrolled (actual)

260

Serious AEs

1.2%

Results posted

Feb 2013

Primary outcomePrimary: Absolute Change From Baseline in Percent Hepatic Fat — 0.03; 4.72 Percent of Hepatic Fat — p=<0.001

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

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

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

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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. Informational only — not medical advice.