Trial Outcomes & Findings for Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS (NCT NCT00559962)
NCT ID: NCT00559962
Last Updated: 2018-02-23
Results Overview
Absolute change from Baseline in percent hepatic fat
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
260 participants
Primary outcome timeframe
Baseline and 12 weeks on study drug
Results posted on
2018-02-23
Participant Flow
The study was performed from 06 Sept 2007 to 05 Sept 2008. A total of 16 medical clinics participated in the study.
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.
Participant milestones
| Measure |
Placebo
Oral placebo every 4 weeks for 12 weeks
|
AEGR-733 2.5 mg
Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg
Oral lomitapide 5 mg every 4 weeks for 12 weeks
|
AEGR-733 7.5 mg
Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
|
AEGR-733 10 mg
Oral lomitapide 10 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg + Atorvastatin 20 mg
Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg + Fenofibrate 145 mg
Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg + Ezetimibe 10 mg
Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
34
|
34
|
34
|
35
|
28
|
33
|
29
|
|
Overall Study
COMPLETED
|
31
|
25
|
24
|
29
|
21
|
23
|
28
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
9
|
10
|
5
|
14
|
5
|
5
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Oral placebo every 4 weeks for 12 weeks
|
AEGR-733 2.5 mg
Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg
Oral lomitapide 5 mg every 4 weeks for 12 weeks
|
AEGR-733 7.5 mg
Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
|
AEGR-733 10 mg
Oral lomitapide 10 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg + Atorvastatin 20 mg
Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg + Fenofibrate 145 mg
Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg + Ezetimibe 10 mg
Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
7
|
8
|
5
|
11
|
4
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
2
|
0
|
3
|
1
|
0
|
2
|
|
Overall Study
Inclusion/exclusion criteria not met
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS
Baseline characteristics by cohort
| Measure |
Placebo
n=33 Participants
Oral placebo every 4 weeks for 12 weeks
|
AEGR-733 2.5 mg
n=34 Participants
Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg
n=34 Participants
Oral lomitapide 5 mg every 4 weeks for 12 weeks
|
AEGR-733 7.5 mg
n=34 Participants
Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
|
AEGR-733 10 mg
n=35 Participants
Oral lomitapide 10 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg + Atorvastatin 20 mg
n=28 Participants
Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg + Fenofibrate 145 mg
n=33 Participants
Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg + Ezetimibe 10 mg
n=29 Participants
Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
|
Total
n=260 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 12.53 • n=5 Participants
|
51.5 years
STANDARD_DEVIATION 12.99 • n=7 Participants
|
48.6 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
49.0 years
STANDARD_DEVIATION 10.24 • n=4 Participants
|
52.9 years
STANDARD_DEVIATION 11.97 • n=21 Participants
|
53.9 years
STANDARD_DEVIATION 8.92 • n=8 Participants
|
54.0 years
STANDARD_DEVIATION 11.95 • n=8 Participants
|
52.7 years
STANDARD_DEVIATION 9.36 • n=24 Participants
|
51.3 years
STANDARD_DEVIATION 11.44 • n=42 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
136 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
17 Participants
n=24 Participants
|
124 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
55 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
22 Participants
n=24 Participants
|
182 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
20 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
34 participants
n=7 Participants
|
34 participants
n=5 Participants
|
34 participants
n=4 Participants
|
35 participants
n=21 Participants
|
28 participants
n=8 Participants
|
33 participants
n=8 Participants
|
29 participants
n=24 Participants
|
260 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeks on study drugPopulation: ITT
Absolute change from Baseline in percent hepatic fat
Outcome measures
| Measure |
Placebo
n=31 Participants
Oral placebo every 4 weeks for 12 weeks
|
AEGR-733 5 mg
n=24 Participants
Oral lomitapide 5 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg
Oral lomitapide 5 mg every 4 weeks for 12 weeks
|
AEGR-733 7.5 mg
Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
|
AEGR-733 10 mg
Oral lomitapide 10 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg + Atorvastatin 20 mg
Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg + Fenofibrate 145 mg
Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg + Ezetimibe 10 mg
Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Percent Hepatic Fat
|
0.03 Percent of Hepatic Fat
Standard Deviation 1.814
|
4.72 Percent of Hepatic Fat
Standard Deviation 6.297
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks on study drugPopulation: ITT
Absolute change from Baseline in percent hepatic fat
Outcome measures
| Measure |
Placebo
n=31 Participants
Oral placebo every 4 weeks for 12 weeks
|
AEGR-733 5 mg
n=27 Participants
Oral lomitapide 5 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg
n=24 Participants
Oral lomitapide 5 mg every 4 weeks for 12 weeks
|
AEGR-733 7.5 mg
n=27 Participants
Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
|
AEGR-733 10 mg
n=20 Participants
Oral lomitapide 10 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg + Atorvastatin 20 mg
n=23 Participants
Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg + Fenofibrate 145 mg
n=26 Participants
Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg + Ezetimibe 10 mg
n=26 Participants
Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Percent Hepatic Fat
|
0.03 Percent of Hepatic Fat
Standard Deviation 1.814
|
4.95 Percent of Hepatic Fat
Standard Deviation 7.122
|
4.72 Percent of Hepatic Fat
Standard Deviation 6.297
|
3.94 Percent of Hepatic Fat
Standard Deviation 5.763
|
7.86 Percent of Hepatic Fat
Standard Deviation 9.515
|
3.68 Percent of Hepatic Fat
Standard Deviation 5.365
|
7.70 Percent of Hepatic Fat
Standard Deviation 9.390
|
7.55 Percent of Hepatic Fat
Standard Deviation 6.230
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
AEGR-733 2.5 mg
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
AEGR-733 5 mg
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
AEGR-733 7.5 mg
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
AEGR-733 10 mg
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
AEGR-733 5 mg + Atorvastatin 20 mg
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
AEGR-733 5 mg + Fenofibrate 145 mg
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
AEGR-733 5 mg + Ezetimibe 10 mg
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=33 participants at risk
Oral placebo every 4 weeks for 12 weeks
|
AEGR-733 2.5 mg
n=34 participants at risk
Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg
n=34 participants at risk
Oral lomitapide 5 mg every 4 weeks for 12 weeks
|
AEGR-733 7.5 mg
n=34 participants at risk
Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
|
AEGR-733 10 mg
n=35 participants at risk
Oral lomitapide 10 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg + Atorvastatin 20 mg
n=28 participants at risk
Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg + Fenofibrate 145 mg
n=33 participants at risk
Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg + Ezetimibe 10 mg
n=29 participants at risk
Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Chest Pain
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/35 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/28 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Gastrointestinal disorders
Inflammatory Bowel Disease
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/35 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/28 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/35 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/28 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/29 • From 10 days before the first dose to 30 days post last dose.
|
Other adverse events
| Measure |
Placebo
n=33 participants at risk
Oral placebo every 4 weeks for 12 weeks
|
AEGR-733 2.5 mg
n=34 participants at risk
Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg
n=34 participants at risk
Oral lomitapide 5 mg every 4 weeks for 12 weeks
|
AEGR-733 7.5 mg
n=34 participants at risk
Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
|
AEGR-733 10 mg
n=35 participants at risk
Oral lomitapide 10 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg + Atorvastatin 20 mg
n=28 participants at risk
Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg + Fenofibrate 145 mg
n=33 participants at risk
Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
|
AEGR-733 5 mg + Ezetimibe 10 mg
n=29 participants at risk
Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
12.1%
4/33 • From 10 days before the first dose to 30 days post last dose.
|
47.1%
16/34 • From 10 days before the first dose to 30 days post last dose.
|
44.1%
15/34 • From 10 days before the first dose to 30 days post last dose.
|
47.1%
16/34 • From 10 days before the first dose to 30 days post last dose.
|
65.7%
23/35 • From 10 days before the first dose to 30 days post last dose.
|
50.0%
14/28 • From 10 days before the first dose to 30 days post last dose.
|
45.5%
15/33 • From 10 days before the first dose to 30 days post last dose.
|
65.5%
19/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Gastrointestinal disorders
Nausea
|
3.0%
1/33 • From 10 days before the first dose to 30 days post last dose.
|
5.9%
2/34 • From 10 days before the first dose to 30 days post last dose.
|
23.5%
8/34 • From 10 days before the first dose to 30 days post last dose.
|
23.5%
8/34 • From 10 days before the first dose to 30 days post last dose.
|
37.1%
13/35 • From 10 days before the first dose to 30 days post last dose.
|
17.9%
5/28 • From 10 days before the first dose to 30 days post last dose.
|
24.2%
8/33 • From 10 days before the first dose to 30 days post last dose.
|
17.2%
5/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Nervous system disorders
Headache
|
12.1%
4/33 • From 10 days before the first dose to 30 days post last dose.
|
5.9%
2/34 • From 10 days before the first dose to 30 days post last dose.
|
17.6%
6/34 • From 10 days before the first dose to 30 days post last dose.
|
23.5%
8/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/35 • From 10 days before the first dose to 30 days post last dose.
|
10.7%
3/28 • From 10 days before the first dose to 30 days post last dose.
|
12.1%
4/33 • From 10 days before the first dose to 30 days post last dose.
|
13.8%
4/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Gastrointestinal disorders
Flatulence
|
6.1%
2/33 • From 10 days before the first dose to 30 days post last dose.
|
17.6%
6/34 • From 10 days before the first dose to 30 days post last dose.
|
8.8%
3/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
5.7%
2/35 • From 10 days before the first dose to 30 days post last dose.
|
17.9%
5/28 • From 10 days before the first dose to 30 days post last dose.
|
3.0%
1/33 • From 10 days before the first dose to 30 days post last dose.
|
20.7%
6/29 • From 10 days before the first dose to 30 days post last dose.
|
|
General disorders
Fatigue
|
6.1%
2/33 • From 10 days before the first dose to 30 days post last dose.
|
8.8%
3/34 • From 10 days before the first dose to 30 days post last dose.
|
14.7%
5/34 • From 10 days before the first dose to 30 days post last dose.
|
8.8%
3/34 • From 10 days before the first dose to 30 days post last dose.
|
8.6%
3/35 • From 10 days before the first dose to 30 days post last dose.
|
3.6%
1/28 • From 10 days before the first dose to 30 days post last dose.
|
9.1%
3/33 • From 10 days before the first dose to 30 days post last dose.
|
3.4%
1/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.1%
2/33 • From 10 days before the first dose to 30 days post last dose.
|
5.9%
2/34 • From 10 days before the first dose to 30 days post last dose.
|
5.9%
2/34 • From 10 days before the first dose to 30 days post last dose.
|
14.7%
5/34 • From 10 days before the first dose to 30 days post last dose.
|
11.4%
4/35 • From 10 days before the first dose to 30 days post last dose.
|
7.1%
2/28 • From 10 days before the first dose to 30 days post last dose.
|
6.1%
2/33 • From 10 days before the first dose to 30 days post last dose.
|
3.4%
1/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Gastrointestinal disorders
Abdominal Distension
|
6.1%
2/33 • From 10 days before the first dose to 30 days post last dose.
|
5.9%
2/34 • From 10 days before the first dose to 30 days post last dose.
|
8.8%
3/34 • From 10 days before the first dose to 30 days post last dose.
|
11.8%
4/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/35 • From 10 days before the first dose to 30 days post last dose.
|
7.1%
2/28 • From 10 days before the first dose to 30 days post last dose.
|
6.1%
2/33 • From 10 days before the first dose to 30 days post last dose.
|
6.9%
2/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
1/33 • From 10 days before the first dose to 30 days post last dose.
|
5.9%
2/34 • From 10 days before the first dose to 30 days post last dose.
|
8.8%
3/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
11.4%
4/35 • From 10 days before the first dose to 30 days post last dose.
|
7.1%
2/28 • From 10 days before the first dose to 30 days post last dose.
|
15.2%
5/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.0%
1/33 • From 10 days before the first dose to 30 days post last dose.
|
11.8%
4/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
5.7%
2/35 • From 10 days before the first dose to 30 days post last dose.
|
7.1%
2/28 • From 10 days before the first dose to 30 days post last dose.
|
6.1%
2/33 • From 10 days before the first dose to 30 days post last dose.
|
13.8%
4/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Gastrointestinal disorders
Constipation
|
9.1%
3/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/35 • From 10 days before the first dose to 30 days post last dose.
|
7.1%
2/28 • From 10 days before the first dose to 30 days post last dose.
|
12.1%
4/33 • From 10 days before the first dose to 30 days post last dose.
|
6.9%
2/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.1%
2/33 • From 10 days before the first dose to 30 days post last dose.
|
5.9%
2/34 • From 10 days before the first dose to 30 days post last dose.
|
8.8%
3/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
8.6%
3/35 • From 10 days before the first dose to 30 days post last dose.
|
3.6%
1/28 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Psychiatric disorders
Insomnia
|
9.1%
3/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
5.9%
2/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/35 • From 10 days before the first dose to 30 days post last dose.
|
3.6%
1/28 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
13.8%
4/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.1%
2/33 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
5.9%
2/34 • From 10 days before the first dose to 30 days post last dose.
|
5.9%
2/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/35 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/28 • From 10 days before the first dose to 30 days post last dose.
|
3.0%
1/33 • From 10 days before the first dose to 30 days post last dose.
|
6.9%
2/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
8.8%
3/34 • From 10 days before the first dose to 30 days post last dose.
|
5.9%
2/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/35 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/28 • From 10 days before the first dose to 30 days post last dose.
|
12.1%
4/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
5.9%
2/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/35 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/28 • From 10 days before the first dose to 30 days post last dose.
|
12.1%
4/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.0%
1/33 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
5.9%
2/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/35 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/28 • From 10 days before the first dose to 30 days post last dose.
|
12.1%
4/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
1/33 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/35 • From 10 days before the first dose to 30 days post last dose.
|
10.7%
3/28 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
3.4%
1/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
5.9%
2/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
5.7%
2/35 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/28 • From 10 days before the first dose to 30 days post last dose.
|
3.0%
1/33 • From 10 days before the first dose to 30 days post last dose.
|
6.9%
2/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
5.9%
2/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/35 • From 10 days before the first dose to 30 days post last dose.
|
3.6%
1/28 • From 10 days before the first dose to 30 days post last dose.
|
3.0%
1/33 • From 10 days before the first dose to 30 days post last dose.
|
6.9%
2/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
11.8%
4/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/35 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/28 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
6.9%
2/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Nervous system disorders
Dizziness
|
3.0%
1/33 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
5.9%
2/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/35 • From 10 days before the first dose to 30 days post last dose.
|
3.6%
1/28 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Infections and infestations
Influenza
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
5.9%
2/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/35 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/28 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
6.9%
2/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
5.9%
2/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/35 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/28 • From 10 days before the first dose to 30 days post last dose.
|
6.1%
2/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
5.7%
2/35 • From 10 days before the first dose to 30 days post last dose.
|
7.1%
2/28 • From 10 days before the first dose to 30 days post last dose.
|
3.0%
1/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/29 • From 10 days before the first dose to 30 days post last dose.
|
|
General disorders
Pyrexia
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/35 • From 10 days before the first dose to 30 days post last dose.
|
7.1%
2/28 • From 10 days before the first dose to 30 days post last dose.
|
6.1%
2/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Investigations
White Blood Cell Count Decreased
|
3.0%
1/33 • From 10 days before the first dose to 30 days post last dose.
|
5.9%
2/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/35 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/28 • From 10 days before the first dose to 30 days post last dose.
|
3.0%
1/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/35 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/28 • From 10 days before the first dose to 30 days post last dose.
|
6.1%
2/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
5.7%
2/35 • From 10 days before the first dose to 30 days post last dose.
|
3.6%
1/28 • From 10 days before the first dose to 30 days post last dose.
|
3.0%
1/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/35 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/28 • From 10 days before the first dose to 30 days post last dose.
|
9.1%
3/33 • From 10 days before the first dose to 30 days post last dose.
|
3.4%
1/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Investigations
Protein Urine
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
5.9%
2/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/35 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/28 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/29 • From 10 days before the first dose to 30 days post last dose.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
2.9%
1/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/35 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/28 • From 10 days before the first dose to 30 days post last dose.
|
6.1%
2/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/35 • From 10 days before the first dose to 30 days post last dose.
|
7.1%
2/28 • From 10 days before the first dose to 30 days post last dose.
|
3.0%
1/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
5.9%
2/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/35 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/28 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
5.9%
2/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/35 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/28 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Gastrointestinal disorders
Eruction
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
5.7%
2/35 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/28 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/29 • From 10 days before the first dose to 30 days post last dose.
|
|
Investigations
C-reactive Protein
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/34 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/35 • From 10 days before the first dose to 30 days post last dose.
|
7.1%
2/28 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/33 • From 10 days before the first dose to 30 days post last dose.
|
0.00%
0/29 • From 10 days before the first dose to 30 days post last dose.
|
Additional Information
Mark Sumeray, MD, Chief Medical Officer
Aegerion Pharmaceuticals
Phone: 617-500-7867
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER