Phase 2 Study of Orlistat and SLx-4090 for the Treatment of Type 1 Hyperlipoproteinemia
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ClinicalTrials.gov Identifier: NCT01675154 |
Recruitment Status :
Terminated
(Due to unavailability of the drug.)
First Posted : August 29, 2012
Results First Posted : August 19, 2021
Last Update Posted : August 19, 2021
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Type 1 Hyperlipoproteinemia |
Interventions |
Drug: SLx-4090 placebo Drug: Orlistat Placebo Drug: Orlistat Drug: Slx-4090 |
Enrollment | 5 |
Recruitment Details | This trial is adaptive design/flexible design. The participants were randomized from the start of the study |
Pre-assignment Details |
Arm/Group Title | SLx-4090 Placebo/Orlistat Placebo First | Orlistat/SLx-4090 Placebo | Orlistat Placebo /SLx-4090 | Orlistat/SLx-4090 |
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First, SLx-4090 (placebo) is dosed as 4 tablets of 50 mg, three times per day with meals. Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat Placebo: Given for 4 weeks |
Then, Orlistat two capsules 60 mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50 mg each, three times per day with meals were administered SLx-4090 placebo: Given for 4 weeks Orlistat: Given for 4 weeks |
Then, Orlistat placebo 2 capsules, 60 mg each three times per day with meals. SLx-4090 4 tablets, 50 mg each. three times per day with meals were administered Orlistat Placebo: Given for 4 weeks SLx-4090: Given for 4 weeks |
Then, Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50 mg each, three times per day with meals were administered Orlistat: Given for 4 weeks SLx-4090: Given for 4 weeks |
Period Title: First Intervention Period (4 Weeks) | ||||
Started | 2 | 1 | 1 | 1 |
Completed | 2 | 1 | 1 | 1 |
Not Completed | 0 | 0 | 0 | 0 |
Period Title: First Washout Period (1 Week) | ||||
Started | 2 [1] | 1 | 1 | 1 |
Completed | 2 | 1 | 1 | 1 |
Not Completed | 0 | 0 | 0 | 0 |
[1]
Subjects were enrolled Regimen 1
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Period Title: Second Intervention Period (4 Weeks) | ||||
Started | 1 | 1 [1] | 1 | 2 |
Completed | 0 | 1 | 1 | 1 |
Not Completed | 1 | 0 | 0 | 1 |
[1]
Subjects were enrolled in Regimen 2
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Period Title: Second Washout Period (1 Week) | ||||
Started | 1 | 1 | 1 | 2 |
Completed | 1 | 1 | 1 | 2 |
Not Completed | 0 | 0 | 0 | 0 |
Period Title: Third Intervention Period (4 Weeks) | ||||
Started [1] | 1 | 1 | 1 | 0 |
Completed | 1 | 0 | 1 | 0 |
Not Completed | 0 | 1 | 0 | 0 |
Reason Not Completed | ||||
Withdrawal by Subject | 0 | 1 | 0 | 0 |
[1]
Further participation of two patients was halted after Period 2 due to unavailability of the study medications.
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Period Title: Third Washout Period (1 Week) | ||||
Started | 1 | 0 | 1 | 0 |
Completed | 1 | 0 | 1 | 0 |
Not Completed | 0 | 0 | 0 | 0 |
Period Title: Fourth Intervention Period (4 Weeks) | ||||
Started | 1 | 0 | 1 | 0 |
Completed [1] | 1 | 0 | 1 | 0 |
Not Completed | 0 | 0 | 0 | 0 |
[1]
One patient dropped out during Period 3 due to personal reasons. Therefore, not included in this intervention period.
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Arm/Group Title | Placebo/Placebo at First Intervention Period | Orlistat/Placebo at First Intervention Period | Orlistat Placebo /Slx-4090 at First Intervention Period | Orlistat/SLx-4090 at First Intervention Period | Total | |
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Slx-4090(placebo) is dosed as 4 tablets of 50 mg, three times per day with meals. Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals. |
Orlistat two capsules 60mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50mg each, three times per day with meals were administered. | Orlistat placebo 2 capsules, 60mg each three times per day with meals. Slx-4090 4 tablets, 50mg each. three times per day with meals were administered | Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals were administered. | Total of all reporting groups | |
Overall Number of Baseline Participants | 2 | 1 | 1 | 1 | 5 | |
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The baseline characteristics are based on first intervention period assignment. This trial is an adaptive design/flexible design using responsive adaptive randomization. The participants were randomized from the start of the study
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 2 participants | 1 participants | 1 participants | 1 participants | 5 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Between 18 and 65 years |
2 100.0%
|
1 100.0%
|
1 100.0%
|
1 100.0%
|
5 100.0%
|
|
>=65 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 2 participants | 1 participants | 1 participants | 1 participants | 5 participants | |
Female |
0 0.0%
|
1 100.0%
|
1 100.0%
|
0 0.0%
|
2 40.0%
|
|
Male |
2 100.0%
|
0 0.0%
|
0 0.0%
|
1 100.0%
|
3 60.0%
|
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 2 participants | 1 participants | 1 participants | 1 participants | 5 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
1 50.0%
|
0 0.0%
|
0 0.0%
|
1 100.0%
|
2 40.0%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
White |
1 50.0%
|
1 100.0%
|
1 100.0%
|
0 0.0%
|
3 60.0%
|
|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
BMI
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 2 participants | 1 participants | 1 participants | 1 participants | 5 participants |
<18.5 kg/m^2 | 0 | 0 | 0 | 0 | 0 | |
18.5 kg/m^2-24.9 kg/m^2 | 1 | 0 | 0 | 1 | 2 | |
25 kg/m^2-29.9 kg/m^2 | 1 | 0 | 0 | 0 | 1 | |
30 kg/m^2-34.9 kg/m^2 | 0 | 1 | 1 | 0 | 2 | |
35 kg/m^2-39.9 kg/m^2 | 0 | 0 | 0 | 0 | 0 | |
>=40 kg/m^2 | 0 | 0 | 0 | 0 | 0 | |
Triglycerides
Mean (Standard Deviation) Unit of measure: mg/dL |
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Number Analyzed | 2 participants | 1 participants | 1 participants | 1 participants | 5 participants | |
1969 (419) | 4840 (0) | 814 (0) | 2061 (0) | 2421 (1480) |
Only five patients were enrolled in the study. Two patients completed the study. One subject dropped our after Second Intervention Period. Participation of other two subjects was halted due to unavailability of study medications.
Study Design: Although protocol states "This trial is randomized, double-blind cross-over trial", study design was actually not a cross over design, but adaptive/flexible design using a responsive adaptive randomization. Thus Arm/Group were not listed "per sequence".
Name/Title: | Dr. Abhimanyu Garg |
Organization: | UT Southwestern Medical Center |
Phone: | 214-648-8295 |
EMail: | abhimanyu.garg@utsouthwestern.edu |
Responsible Party: | Abhimanyu Garg, University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT01675154 |
Other Study ID Numbers: |
3940 FD-R-003940 |
First Submitted: | August 27, 2012 |
First Posted: | August 29, 2012 |
Results First Submitted: | May 21, 2021 |
Results First Posted: | August 19, 2021 |
Last Update Posted: | August 19, 2021 |