Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS
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
1 other identifier
interventional
260
1 country
15
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2007
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 15, 2007
CompletedFirst Posted
Study publicly available on registry
November 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
February 22, 2013
CompletedFebruary 23, 2018
February 1, 2018
1 year
November 15, 2007
January 18, 2013
February 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute Change From Baseline in Percent Hepatic Fat
Absolute change from Baseline in percent hepatic fat
Baseline and 12 weeks on study drug
Secondary Outcomes (1)
Absolute Change From Baseline in Percent Hepatic Fat
Baseline and 12 weeks on study drug
Study Arms (8)
1
PLACEBO COMPARATORPlacebo
2
ACTIVE COMPARATOR2.5 mg AEGR-733
3
ACTIVE COMPARATOR5 mg AEGR-733
4
ACTIVE COMPARATOR7.5 mg AEGR-733
5
ACTIVE COMPARATOR10 mg AEGR-733
6
ACTIVE COMPARATOR5 mg AEGR-733 + 20 mg atorvastatin
7
ACTIVE COMPARATOR5 mg AEGR-733 + 145 mg fenofibrate
8
ACTIVE COMPARATOR5 mg AEGR-733 + 10 mg ezetimibe
Interventions
Eligibility Criteria
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)
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Scripps Clinic
San Diego, California, 92128, United States
Radiant Research
Santa Rosa, California, 95405, United States
MedStar Research Institute
Washington D.C., District of Columbia, 20003, United States
Radiant Research
Chicago, Illinois, 60610, United States
University of Iowa
Iowa City, Iowa, 52242, United States
LMARC
Louisville, Kentucky, 40213, United States
Maine Research Associates
Auburn, Maine, 04210, United States
Health Trends Research
Baltimore, Maryland, 21209, United States
Johns Hopkins
Baltimore, Maryland, 21287, United States
Washington Univ. School of Medicine
St Louis, Missouri, 63110, United States
Sterling Research Group
Cincinnati, Ohio, 45219, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Clinical Trial Network
Houston, Texas, 77074, United States
dgd Research
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mark Sumeray, MD, Chief Medical Officer
- Organization
- Aegerion Pharmaceuticals
Study Officials
- STUDY DIRECTOR
William Sasiela, PhD
Aegerion Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 15, 2007
First Posted
November 19, 2007
Study Start
October 1, 2007
Primary Completion
October 1, 2008
Study Completion
November 1, 2008
Last Updated
February 23, 2018
Results First Posted
February 22, 2013
Record last verified: 2018-02