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

Sponsor:	Aegerion Pharmaceuticals, Inc.
Information provided by:	Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00559962

Purpose

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

Condition	Intervention	Phase
Hyperlipidemia	Drug: AEGR-733 Drug: placebo Drug: AEGR-733 and atorvastatin Drug: AEGR-733 and fenofibrate Drug: AEGR-733 and ezetimibe	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Procetofen Atorvastatin Atorvastatin calcium Ezetimibe BMS201038

U.S. FDA Resources

Further study details as provided by Aegerion Pharmaceuticals, Inc.:

Primary Outcome Measures:

Percent change from baseline in hepatic fat content at 12 weeks measured by MRS for AEGR-733-5mg compared to placebo. [ Time Frame: Following 12 weeks on study drug ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Percent change from baseline in hepatic fat content as measured by MRS between treatment groups. [ Time Frame: Following 12 weeks on study drug ] [ Designated as safety issue: Yes ]

Enrollment:	260
Study Start Date:	October 2007
Study Completion Date:	November 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Placebo	Drug: placebo 3 capsules each evening for each 4-week period Other Name: Placebo
Active Comparator: 2 2.5 mg AEGR-733	Drug: AEGR-733 3 capsules each evening for each 4-week period Other Name: AEGR-733
Active Comparator: 3 5 mg AEGR-733	Drug: AEGR-733 3 capsules each evening for each 4-week period Other Name: AEGR-733
Active Comparator: 4 7.5 mg AEGR-733	Drug: AEGR-733 3 capsules each evening for each 4-week period Other Name: AEGR-733
Active Comparator: 5 10 mg AEGR-733	Drug: AEGR-733 3 capsules each evening for each 4-week period Other Name: AEGR-733
Active Comparator: 6 5 mg AEGR-733 + 20 mg atorvastatin	Drug: AEGR-733 and atorvastatin 3 capsules each evening for each 4-week period Other Name: AEGR-733 and atorvastatin
Active Comparator: 7 5 mg AEGR-733 + 145 mg fenofibrate	Drug: AEGR-733 and fenofibrate 3 capsules each evening for each 4-week period Other Name: AEGR-733 and fenofibrate
Active Comparator: 8 5 mg AEGR-733 + 10 mg ezetimibe	Drug: AEGR-733 and ezetimibe 3 capsules each evening for each 4-week period Other Name: AEGR-733 and ezetimibe

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559962

Locations

United States, California
Scripps Clinic
San Diego, California, United States, 92128
Radiant Research
Santa Rosa, California, United States, 95405
United States, District of Columbia
MedStar Research Institute
Washington, District of Columbia, United States, 20003
United States, Illinois
Radiant Research
Chicago, Illinois, United States, 60610
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
LMARC
Louisville, Kentucky, United States, 40213
United States, Maine
Maine Research Associates
Auburn, Maine, United States, 04210
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21287
Health Trends Research
Baltimore, Maryland, United States, 21209
United States, Missouri
Washington Univ. School of Medicine
St. Louis, Missouri, United States, 63110
United States, Ohio
Sterling Research Group
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Clinical Trial Network
Houston, Texas, United States, 77074
dgd Research
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Aegerion Pharmaceuticals, Inc.

Investigators

Study Director:

William Sasiela, PhD

Aegerion Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	William J Sasiela, PhD Chief Medical Officer, Aegerion Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00559962 History of Changes
Other Study ID Numbers:	733-004
Study First Received:	November 15, 2007
Last Updated:	June 23, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Aegerion Pharmaceuticals, Inc.:

LDL
hepatic fat

Additional relevant MeSH terms:

Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Atorvastatin
Ezetimibe
Hypolipidemic Agents

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012