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

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ClinicalTrials.gov Identifier: NCT00559962
Recruitment Status : Completed
First Posted : November 19, 2007
Results First Posted : February 22, 2013
Last Update Posted : February 23, 2018
Sponsor:
Information provided by:
Aegerion Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE November 15, 2007
First Posted Date  ICMJE November 19, 2007
Results First Submitted Date  ICMJE January 18, 2013
Results First Posted Date  ICMJE February 22, 2013
Last Update Posted Date February 23, 2018
Study Start Date  ICMJE October 2007
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2014)
Absolute Change From Baseline in Percent Hepatic Fat [ Time Frame: Baseline and 12 weeks on study drug ]
Absolute change from Baseline in percent hepatic fat
Original Primary Outcome Measures  ICMJE
 (submitted: November 16, 2007)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2014)
Absolute Change From Baseline in Percent Hepatic Fat [ Time Frame: Baseline and 12 weeks on study drug ]
Absolute change from Baseline in percent hepatic fat
Original Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2007)
Percent change from baseline in hepatic fat content as measured by MRS between treatment groups. [ Time Frame: Following 12 weeks on study drug ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hyperlipidemia
Intervention  ICMJE
  • Drug: AEGR-733
    3 capsules each evening for each 4-week period
  • Drug: placebo
    3 capsules each evening for each 4-week period
  • Drug: AEGR-733 and atorvastatin
    3 capsules each evening for each 4-week period
  • Drug: AEGR-733 and fenofibrate
    3 capsules each evening for each 4-week period
  • Drug: AEGR-733 and ezetimibe
    3 capsules each evening for each 4-week period
Study Arms  ICMJE
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: placebo
  • Active Comparator: 2
    2.5 mg AEGR-733
    Intervention: Drug: AEGR-733
  • Active Comparator: 3
    5 mg AEGR-733
    Intervention: Drug: AEGR-733
  • Active Comparator: 4
    7.5 mg AEGR-733
    Intervention: Drug: AEGR-733
  • Active Comparator: 5
    10 mg AEGR-733
    Intervention: Drug: AEGR-733
  • Active Comparator: 6
    5 mg AEGR-733 + 20 mg atorvastatin
    Intervention: Drug: AEGR-733 and atorvastatin
  • Active Comparator: 7
    5 mg AEGR-733 + 145 mg fenofibrate
    Intervention: Drug: AEGR-733 and fenofibrate
  • Active Comparator: 8
    5 mg AEGR-733 + 10 mg ezetimibe
    Intervention: Drug: AEGR-733 and ezetimibe
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2008)
260
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2007)
240
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. LDL-C between 100 and 190 mg/dL
  2. Hepatic fat under 6.2% per MRS

Exclusion Criteria:

  1. Pregnant or lactating females
  2. Uncontrolled hypertension >180/95 mmHg
  3. Chronic renal insufficiency - serum creatinine >2.5 mg/dL at screen
  4. Liver disease; i.e., hepatitis, cirrhosis
  5. Major surgery within 3 months of screen
  6. Cardiac insufficiency
  7. Hx of malignancy other than basal or squamous cell within past 5 yrs
  8. Participation in any investigational drug study within 6 wks of screen
  9. Prior exposure to AEGR-733 in past 12 months
  10. Serious or unstable medical or psychological conditions
  11. More than one alcoholic drink per day
  12. Regular consumption of grapefruit juice or meds known to be metabolized by CYP 3A4
  13. Currently taking corticosteroids
  14. Other lipid-lowering meds (washout permitted)
  15. Fish oil, niacin grater than 200 mg/day and herbal weight loss products (washout permitted)
  16. Acute CVD or event within previous 6 months
  17. Diabetes Mellitus
  18. Hepatitis B or C
  19. Medicated COPD
  20. Idiopathic pulmonary fibrosis
  21. G.I. disorders that cause chronic diarrhea
  22. Fasting triglycerides =/> 400 mg/dL
  23. Body Mass Index > 35kg/m2
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00559962
Other Study ID Numbers  ICMJE AEGR-733-004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party William J Sasiela, PhD Chief Medical Officer, Aegerion Pharmaceuticals
Study Sponsor  ICMJE Aegerion Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: William Sasiela, PhD Aegerion Pharmaceuticals, Inc.
PRS Account Aegerion Pharmaceuticals, Inc.
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP