Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulatio... | NCT00559962 | Trialant
NCT00559962
Sponsor
Aegerion Pharmaceuticals, Inc.
Status
Completed
Last Update Posted
Feb 23, 2018Actual
Enrollment
260Actual
Phase
Phase 2
Conditions
Hyperlipidemia
Interventions
AEGR-733
placebo
AEGR-733
AEGR-733
AEGR-733
AEGR-733 and atorvastatin
AEGR-733 and fenofibrate
AEGR-733 and ezetimibe
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00559962
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
AEGR-733-004
Secondary IDs
Not provided
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
Acronym
Not provided
Organization
Aegerion Pharmaceuticals, Inc.INDUSTRY
Status Module
Record Verification Date
Feb 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2007
Primary Completion Date
Oct 2008Actual
Completion Date
Nov 2008Actual
First Submitted Date
Nov 15, 2007
First Submission Date that Met QC Criteria
Nov 16, 2007
First Posted Date
Nov 19, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 18, 2013
Results First Submitted that Met QC Criteria
Jan 18, 2013
Results First Posted Date
Feb 22, 2013Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 21, 2018
Last Update Posted Date
Feb 23, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Aegerion Pharmaceuticals, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
Hyperlipidemia
Keywords
LDL
hepatic fat
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
260Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Placebo Comparator
Placebo
Drug: placebo
2
Active Comparator
2.5 mg AEGR-733
Drug: AEGR-733
3
Active Comparator
5 mg AEGR-733
Drug: AEGR-733
4
Active Comparator
7.5 mg AEGR-733
Drug: AEGR-733
5
Active Comparator
10 mg AEGR-733
Drug: AEGR-733
6
Active Comparator
5 mg AEGR-733 + 20 mg atorvastatin
Drug: AEGR-733 and atorvastatin
7
Active Comparator
Interventions
Name
Type
Description
Arm Group Labels
Other Names
AEGR-733
Drug
3 capsules each evening for each 4-week period
2
placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
Measure
Description
Time Frame
Absolute Change From Baseline in Percent Hepatic Fat
Absolute change from Baseline in percent hepatic fat
Baseline and 12 weeks on study drug
Other Outcomes
Not provided
Eligibility Module
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
70 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
William Sasiela, PhD
Aegerion Pharmaceuticals, Inc.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Scripps Clinic
San Diego
California
92128
United States
Radiant Research
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Subjects underwent a 5- to 9-week screening washout period to determine study eligibility and to wash-out patients of all lipid-lowering therapies; patients were required to have low-density lipoprotein cholesterol (LDL-C) between 100 and 190 mg/dL (average of 2 visits during screening) and hepatic fat less than 6.2% for randomization.
Recruitment Details
The study was performed from 06 Sept 2007 to 05 Sept 2008. A total of 16 medical clinics participated in the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Oral placebo every 4 weeks for 12 weeks
FG001
AEGR-733 2.5 mg
Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
5 mg AEGR-733 + 145 mg fenofibrate
Drug: AEGR-733 and fenofibrate
8
Active Comparator
5 mg AEGR-733 + 10 mg ezetimibe
Drug: AEGR-733 and ezetimibe
Drug
3 capsules each evening for each 4-week period
1
AEGR-733
Drug
3 capsules each evening for each 4-week period
3
AEGR-733
Drug
3 capsules each evening for each 4-week period
4
AEGR-733
Drug
3 capsules each evening for each 4-week period
5
AEGR-733 and atorvastatin
Drug
3 capsules each evening for each 4-week period
6
AEGR-733 and fenofibrate
Drug
3 capsules each evening for each 4-week period
7
AEGR-733 and ezetimibe
Drug
3 capsules each evening for each 4-week period
8
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
FG002
AEGR-733 5 mg
Oral lomitapide 5 mg every 4 weeks for 12 weeks
FG003
AEGR-733 7.5 mg
Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
FG004
AEGR-733 10 mg
Oral lomitapide 10 mg every 4 weeks for 12 weeks
FG005
AEGR-733 5 mg + Atorvastatin 20 mg
Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
FG006
AEGR-733 5 mg + Fenofibrate 145 mg
Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
FG007
AEGR-733 5 mg + Ezetimibe 10 mg
Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
FG00033 subjects
FG00134 subjects
FG00234 subjects
FG00334 subjects
FG00435 subjects
FG00528 subjects
FG00633 subjects
FG00729 subjects
COMPLETED
FG00031 subjects
FG00125 subjects
FG00224 subjects
FG00329 subjects
FG00421 subjects
FG00523 subjects
FG00628 subjects
FG00725 subjects
NOT COMPLETED
FG0002 subjects
FG0019 subjects
FG00210 subjects
FG0035 subjects
FG00414 subjects
FG0055 subjects
FG0065 subjects
FG0074 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0017 subjects
FG0028 subjects
FG0035 subjects
FG00411 subjects
FG0054 subjects
FG0064 subjects
FG0072 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Inclusion/exclusion criteria not met
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Oral placebo every 4 weeks for 12 weeks
BG001
AEGR-733 2.5 mg
Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
BG002
AEGR-733 5 mg
Oral lomitapide 5 mg every 4 weeks for 12 weeks
BG003
AEGR-733 7.5 mg
Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
BG004
AEGR-733 10 mg
Oral lomitapide 10 mg every 4 weeks for 12 weeks
BG005
AEGR-733 5 mg + Atorvastatin 20 mg
Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
BG006
AEGR-733 5 mg + Fenofibrate 145 mg
Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
BG007
AEGR-733 5 mg + Ezetimibe 10 mg
Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00033
BG00134
BG00234
BG00334
BG00435
BG00528
BG00633
BG00729
BG008260
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00047.8± 12.53
BG00151.5± 12.99
BG00248.6± 11.3
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00019
BG00118
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00033
BG00134
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Absolute Change From Baseline in Percent Hepatic Fat
Absolute change from Baseline in percent hepatic fat
ITT
Posted
Mean
Standard Deviation
Percent of Hepatic Fat
Baseline and 12 weeks on study drug
ID
Title
Description
OG000
Placebo
Oral placebo every 4 weeks for 12 weeks
OG001
AEGR-733 5 mg
Oral lomitapide 5 mg every 4 weeks for 12 weeks
Units
Counts
Participants
OG00031
OG00124
Title
Denominators
Categories
Title
Measurements
OG0000.03± 1.814
OG0014.72± 6.297
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
One-way analysis of variance (ANOVA) to compare the absolute change from baseline to Week 12 in percent hepatic fat between AEGR-755 5 mg and placebo.
ANOVA
<0.001
Mean Difference (Final Values)
4.68
2-Sided
95
2.30
7.07
Superiority or Other
Secondary
Absolute Change From Baseline in Percent Hepatic Fat
Absolute change from Baseline in percent hepatic fat
ITT
Posted
Mean
Standard Deviation
Percent of Hepatic Fat
Baseline and 12 weeks on study drug
ID
Title
Description
OG000
Placebo
Oral placebo every 4 weeks for 12 weeks
OG001
AEGR-733 2.5 mg
Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
OG002
AEGR-733 5 mg
Oral lomitapide 5 mg every 4 weeks for 12 weeks
OG003
AEGR-733 7.5 mg
Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
OG004
AEGR-733 10 mg
Oral lomitapide 10 mg every 4 weeks for 12 weeks
OG005
Time Frame
From 10 days before the first dose to 30 days post last dose.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Oral placebo every 4 weeks for 12 weeks
0
33
20
33
EG001
AEGR-733 2.5 mg
Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
1
34
31
34
EG002
AEGR-733 5 mg
Oral lomitapide 5 mg every 4 weeks for 12 weeks
0
34
30
34
EG003
AEGR-733 7.5 mg
Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
0
34
29
34
EG004
AEGR-733 10 mg
Oral lomitapide 10 mg every 4 weeks for 12 weeks
2
35
32
35
EG005
AEGR-733 5 mg + Atorvastatin 20 mg
Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
0
28
24
28
EG006
AEGR-733 5 mg + Fenofibrate 145 mg
Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
0
33
29
33
EG007
AEGR-733 5 mg + Ezetimibe 10 mg
Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
0
29
25
29
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Chest Pain
General disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0000 affected33 at risk
EG0011 affected34 at risk
EG0020 affected34 at risk
EG0030 affected34 at risk
EG0040 affected35 at risk
EG0050 affected28 at risk
EG0060 affected33 at risk
EG0070 affected29 at risk
Inflammatory Bowel Disease
Gastrointestinal disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0000 affected33 at risk
EG0010 affected34 at risk
EG0020 affected34 at risk
EG003
Ankle Fracture
Injury, poisoning and procedural complications
MedDRA, version 14.0
Non-systematic Assessment
EG0000 affected33 at risk
EG0010 affected34 at risk
EG0020 affected34 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0004 affected33 at risk
EG00116 affected34 at risk
EG00215 affected34 at risk
EG00316 affected34 at risk
EG00423 affected35 at risk
EG00514 affected28 at risk
EG00615 affected33 at risk
EG00719 affected29 at risk
Nausea
Gastrointestinal disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0001 affected33 at risk
EG0012 affected34 at risk
EG0028 affected34 at risk
EG003
Headache
Nervous system disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0004 affected33 at risk
EG0012 affected34 at risk
EG0026 affected34 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0002 affected33 at risk
EG0016 affected34 at risk
EG0023 affected34 at risk
EG003
Fatigue
General disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0002 affected33 at risk
EG0013 affected34 at risk
EG0025 affected34 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0002 affected33 at risk
EG0012 affected34 at risk
EG0022 affected34 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0002 affected33 at risk
EG0012 affected34 at risk
EG0023 affected34 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0001 affected33 at risk
EG0012 affected34 at risk
EG0023 affected34 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0001 affected33 at risk
EG0014 affected34 at risk
EG0021 affected34 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0003 affected33 at risk
EG0010 affected34 at risk
EG0020 affected34 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0002 affected33 at risk
EG0012 affected34 at risk
EG0023 affected34 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0003 affected33 at risk
EG0010 affected34 at risk
EG0022 affected34 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0002 affected33 at risk
EG0011 affected34 at risk
EG0022 affected34 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA, version 14.0
Non-systematic Assessment
EG0000 affected33 at risk
EG0013 affected34 at risk
EG0022 affected34 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA, version 14.0
Non-systematic Assessment
EG0000 affected33 at risk
EG0012 affected34 at risk
EG0021 affected34 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA, version 14.0
Non-systematic Assessment
EG0001 affected33 at risk
EG0011 affected34 at risk
EG0020 affected34 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA, version 14.0
Non-systematic Assessment
EG0001 affected33 at risk
EG0011 affected34 at risk
EG0020 affected34 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0000 affected33 at risk
EG0012 affected34 at risk
EG0020 affected34 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0000 affected33 at risk
EG0011 affected34 at risk
EG0022 affected34 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0000 affected33 at risk
EG0010 affected34 at risk
EG0024 affected34 at risk
EG003
Dizziness
Nervous system disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0001 affected33 at risk
EG0011 affected34 at risk
EG0022 affected34 at risk
EG003
Influenza
Infections and infestations
MedDRA, version 14.0
Non-systematic Assessment
EG0000 affected33 at risk
EG0011 affected34 at risk
EG0022 affected34 at risk
EG003
Seasonal Allergy
Immune system disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0000 affected33 at risk
EG0010 affected34 at risk
EG0021 affected34 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0000 affected33 at risk
EG0010 affected34 at risk
EG0021 affected34 at risk
EG003
Pyrexia
General disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0000 affected33 at risk
EG0010 affected34 at risk
EG0021 affected34 at risk
EG003
White Blood Cell Count Decreased
Investigations
MedDRA, version 14.0
Non-systematic Assessment
EG0001 affected33 at risk
EG0012 affected34 at risk
EG0021 affected34 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0000 affected33 at risk
EG0011 affected34 at risk
EG0020 affected34 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0000 affected33 at risk
EG0010 affected34 at risk
EG0020 affected34 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0000 affected33 at risk
EG0010 affected34 at risk
EG0020 affected34 at risk
EG003
Protein Urine
Investigations
MedDRA, version 14.0
Non-systematic Assessment
EG0000 affected33 at risk
EG0010 affected34 at risk
EG0022 affected34 at risk
EG003
Influenza Like Illness
General disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0000 affected33 at risk
EG0010 affected34 at risk
EG0021 affected34 at risk
EG003
Gastrointestinal Pain
Gastrointestinal disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0000 affected33 at risk
EG0010 affected34 at risk
EG0020 affected34 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0000 affected33 at risk
EG0010 affected34 at risk
EG0022 affected34 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0000 affected33 at risk
EG0010 affected34 at risk
EG0022 affected34 at risk
EG003
Eruction
Gastrointestinal disorders
MedDRA, version 14.0
Non-systematic Assessment
EG0000 affected33 at risk
EG0010 affected34 at risk
EG0020 affected34 at risk
EG003
C-reactive Protein
Investigations
MedDRA, version 14.0
Non-systematic Assessment
EG0000 affected33 at risk
EG0010 affected34 at risk
EG0020 affected34 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
PI can publish after sponsor reviews the proposed publication. PI must give sponsor at least 60 days to review before publication. PI needs to obtain sponsor's prior written consent to publish confidential information, which shall not be unreasonably withheld or delayed. The PI shall, upon request of sponsor, delete any confidential information which would prejudice the securing of adequate intellectual property protection from the publication.
Point of Contact
Title
Organization
Phone
Extension
Email
Mark Sumeray, MD, Chief Medical Officer
Aegerion Pharmaceuticals
617-500-7867
ID
Term
D006949
Hyperlipidemias
Ancestor Terms
ID
Term
D050171
Dyslipidemias
D052439
Lipid Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C473731
BMS201038
D000069059
Atorvastatin
D011345
Fenofibrate
D000069438
Ezetimibe
Ancestor Terms
ID
Term
D011758
Pyrroles
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D006538
Heptanoic Acids
D005227
Fatty Acids
D008055
Lipids
D058607
Fibric Acids
D058610
Isobutyrates
D002087
Butyrates
D000144
Acids, Acyclic
D002264
Carboxylic Acids
D009930
Organic Chemicals
D010647
Phenyl Ethers
D004987
Ethers
D001577
Benzophenones
D001555
Benzene Derivatives
D006841
Hydrocarbons, Aromatic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D010636
Phenols
D007659
Ketones
D001384
Azetidines
D001385
Azetines
Browse Leaves
Not provided
Browse Branches
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0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
3 subjects
FG0051 subjects
FG0060 subjects
FG0072 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
49.0
± 10.24
BG00452.9± 11.97
BG00553.9± 8.92
BG00654.0± 11.95
BG00752.7± 9.36
BG00851.3± 11.44
16
BG00317
BG00420
BG00517
BG00617
BG00712
BG008136
Male
BG00014
BG00116
BG00218
BG00317
BG00415
BG00511
BG00616
BG00717
BG008124
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Asian
BG0001
BG0010
BG0020
BG0031
BG0040
BG0050
BG0061
BG0070
BG0083
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Black or African American
BG0005
BG0019
BG0028
BG0039
BG0048
BG0054
BG0067
BG0075
BG00855
White
BG00024
BG00121
BG00224
BG00323
BG00422
BG00522
BG00624
BG00722
BG008182
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Unknown or Not Reported
BG0003
BG0014
BG0022
BG0031
BG0045
BG0052
BG0061
BG0072
BG00820
34
BG00334
BG00435
BG00528
BG00633
BG00729
BG008260
AEGR-733 5 mg + Atorvastatin 20 mg
Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
OG006
AEGR-733 5 mg + Fenofibrate 145 mg
Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
OG007
AEGR-733 5 mg + Ezetimibe 10 mg
Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
Units
Counts
Participants
OG00031
OG00127
OG00224
OG00327
OG00420
OG00523
OG00626
OG00726
Title
Denominators
Categories
Title
Measurements
OG0000.03± 1.814
OG0014.95± 7.122
OG0024.72± 6.297
OG0033.94± 5.763
OG0047.86± 9.515
OG0053.68± 5.365
OG0067.70± 9.390
OG0077.55± 6.230
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo
ANOVA
<0.001
(All comparisons)
Mean Difference (Final Values)
4.92
2-Sided
95
2.27
7.57
Superiority or Other
OG000
OG002
ANOVA
<0.001
(All comparisons)
Mean Difference (Final Values)
4.68
2-Sided
95
2.30
7.07
Superiority or Other
OG000
OG003
One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo
ANOVA
<0.001
(All comparisons)
Mean Difference (Final Values)
3.91
2-Sided
95
1.73
6.10
Superiority or Other
OG000
OG004
ANOVA
<0.001
(All comparisons)
Mean Difference (Final Values)
7.82
2-Sided
95
4.31
11.33
Superiority or Other
OG000
OG005
One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo
ANOVA
<0.001
(All comparisons)
Mean Difference (Final Values)
3.65
2-Sided
95
1.58
5.72
Superiority or Other
OG000
OG006
One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo
ANOVA
<0.001
(All comparisons)
Mean Difference (Final Values)
7.66
2-Sided
95
4.22
11.11
Superiority or Other
OG000
OG007
One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo