Back to resultsEvaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS
Primary Purpose
Hyperlipidemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AEGR-733
placebo
AEGR-733
AEGR-733
AEGR-733
AEGR-733 and atorvastatin
AEGR-733 and fenofibrate
AEGR-733 and ezetimibe
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipidemia focused on measuring LDL, hepatic fat
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
Sites / Locations
- Scripps Clinic
- Radiant Research
- MedStar Research Institute
- Radiant Research
- University of Iowa
- LMARC
- Maine Research Associates
- Health Trends Research
- Johns Hopkins
- Washington Univ. School of Medicine
- Sterling Research Group
- University of Pennsylvania
- Baylor College of Medicine
- Clinical Trial Network
- dgd Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
4
5
6
7
8
Arm Description
Placebo
2.5 mg AEGR-733
5 mg AEGR-733
7.5 mg AEGR-733
10 mg AEGR-733
5 mg AEGR-733 + 20 mg atorvastatin
5 mg AEGR-733 + 145 mg fenofibrate
5 mg AEGR-733 + 10 mg ezetimibe
Outcomes
Primary Outcome Measures
Absolute Change From Baseline in Percent Hepatic Fat
Absolute change from Baseline in percent hepatic fat
Secondary Outcome Measures
Absolute Change From Baseline in Percent Hepatic Fat
Absolute change from Baseline in percent hepatic fat
Full Information
NCT ID
NCT00559962
First Posted
November 15, 2007
Last Updated
February 21, 2018
Sponsor
Aegerion Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00559962
Brief Title
Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Aegerion Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
LDL, hepatic fat
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
2
Arm Type
Active Comparator
Arm Description
2.5 mg AEGR-733
Arm Title
3
Arm Type
Active Comparator
Arm Description
5 mg AEGR-733
Arm Title
4
Arm Type
Active Comparator
Arm Description
7.5 mg AEGR-733
Arm Title
5
Arm Type
Active Comparator
Arm Description
10 mg AEGR-733
Arm Title
6
Arm Type
Active Comparator
Arm Description
5 mg AEGR-733 + 20 mg atorvastatin
Arm Title
7
Arm Type
Active Comparator
Arm Description
5 mg AEGR-733 + 145 mg fenofibrate
Arm Title
8
Arm Type
Active Comparator
Arm Description
5 mg AEGR-733 + 10 mg ezetimibe
Intervention Type
Drug
Intervention Name(s)
AEGR-733
Intervention Description
3 capsules each evening for each 4-week period
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
3 capsules each evening for each 4-week period
Intervention Type
Drug
Intervention Name(s)
AEGR-733
Intervention Description
3 capsules each evening for each 4-week period
Intervention Type
Drug
Intervention Name(s)
AEGR-733
Intervention Description
3 capsules each evening for each 4-week period
Intervention Type
Drug
Intervention Name(s)
AEGR-733
Intervention Description
3 capsules each evening for each 4-week period
Intervention Type
Drug
Intervention Name(s)
AEGR-733 and atorvastatin
Intervention Description
3 capsules each evening for each 4-week period
Intervention Type
Drug
Intervention Name(s)
AEGR-733 and fenofibrate
Intervention Description
3 capsules each evening for each 4-week period
Intervention Type
Drug
Intervention Name(s)
AEGR-733 and ezetimibe
Intervention Description
3 capsules each evening for each 4-week period
Primary Outcome Measure Information:
Title
Absolute Change From Baseline in Percent Hepatic Fat
Description
Absolute change from Baseline in percent hepatic fat
Time Frame
Baseline and 12 weeks on study drug
Secondary Outcome Measure Information:
Title
Absolute Change From Baseline in Percent Hepatic Fat
Description
Absolute change from Baseline in percent hepatic fat
Time Frame
Baseline and 12 weeks on study drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Sasiela, PhD
Organizational Affiliation
Aegerion Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Scripps Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Facility Name
Radiant Research
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
MedStar Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20003
Country
United States
Facility Name
Radiant Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
LMARC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Maine Research Associates
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Health Trends Research
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Washington Univ. School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Sterling Research Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clinical Trial Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
dgd Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
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Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS
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