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Phase 2 Study of Orlistat and SLx-4090 for the Treatment of Type 1 Hyperlipoproteinemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Abhimanyu Garg, University of Texas Southwestern Medical Center

Study Type Interventional
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
Hide Arm/Group Description

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
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
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.
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.
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
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
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
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
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%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
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%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
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
Number Analyzed 2 participants 1 participants 1 participants 1 participants 5 participants
1969  (419) 4840  (0) 814  (0) 2061  (0) 2421  (1480)
1.Primary Outcome
Title Serum Triglycerides at First Intervention Period
Hide Description Serum triglyceride level will be measured after taking each assigned intervention at first intervention period.
Time Frame 4 weeks after the assigned treatment (first intervention period)
Hide Outcome Measure Data
Hide Analysis Population Description
This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment.
Arm/Group Title SLx-4090 Placebo/Orlistat Placebo Orlistat/Placebo Orlistat Placebo /Slx-4090 Orlistat/SLx-4090
Hide Arm/Group Description:

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

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.

SLx-4090 placebo: Given for 4 weeks

Orlistat: Given for 4 weeks

Orlistat placebo 2 capsules, 60mg each three times per day with meals. Slx-4090 4 tablets, 50mg each. three times per day with meals.

Orlistat Placebo: Given for 4 weeks

Slx-4090: Given for 4 weeks

Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals.

Orlistat: Given for 4 weeks

Slx-4090: Given for 4 weeks

Overall Number of Participants Analyzed 2 1 1 1
Mean (Standard Deviation)
Unit of Measure: mg/dL
2086  (481.54) 3320 1576 1280
2.Primary Outcome
Title Serum Triglycerides at Second Intervention Period
Hide Description Serum triglyceride level will be measured after taking each assigned intervention at second intervention period
Time Frame 4 weeks after the assigned treatment (Second Intervention Period)
Hide Outcome Measure Data
Hide Analysis Population Description

Patient assigned to SLX-4090 placebo/Orlistat placebo group withdrew from the study in this phase.

One more subject was assigned to the Orlistat/SLx-4090 but could not start the study as the drug SLx-4090 was not available.

This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment.

Arm/Group Title SLx-4090 Placebo/Orlistat Placebo Orlistat/Placebo Orlistat Placebo /Slx-4090 Orlistat/SLx-4090
Hide Arm/Group Description:

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

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.

SLx-4090 placebo: Given for 4 weeks

Orlistat: Given for 4 weeks

Orlistat placebo 2 capsules, 60mg each three times per day with meals. Slx-4090 4 tablets, 50mg each. three times per day with meals.

Orlistat Placebo: Given for 4 weeks

Slx-4090: Given for 4 weeks

Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals.

Orlistat: Given for 4 weeks

Slx-4090: Given for 4 weeks

Overall Number of Participants Analyzed 0 1 1 1
Mean (Standard Deviation)
Unit of Measure: mg/dL
1419 2040 3478
3.Primary Outcome
Title Serum Triglycerides at Third Intervention Period
Hide Description Serum triglyceride level will be measured after taking each assigned intervention at intervention period
Time Frame 4 weeks after the assigned treatment (Third Intervention Period)
Hide Outcome Measure Data
Hide Analysis Population Description

Patient assigned to Orlistat/SLX-4090 placebo group did not start the assigned treatment due to lack of drugs.

This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment.

Arm/Group Title SLx-4090 Placebo/Orlistat Placebo Orlistat/Placebo Orlistat Placebo /Slx-4090 Orlistat/SLx-4090
Hide Arm/Group Description:

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

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.

SLx-4090 placebo: Given for 4 weeks

Orlistat: Given for 4 weeks

Orlistat placebo 2 capsules, 60mg each three times per day with meals. Slx-4090 4 tablets, 50mg each. three times per day with meals.

Orlistat Placebo: Given for 4 weeks

Slx-4090: Given for 4 weeks

Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals.

Orlistat: Given for 4 weeks

Slx-4090: Given for 4 weeks

Overall Number of Participants Analyzed 1 0 1 0
Mean (Standard Deviation)
Unit of Measure: mg/dL
6220 1320
4.Primary Outcome
Title Serum Triglycerides at Fourth Intervention Period
Hide Description Serum triglyceride level will be measured after taking each assigned intervention at fourth intervention period
Time Frame 4 weeks after the assigned treatment (Fourth Intervention Period)
Hide Outcome Measure Data
Hide Analysis Population Description

Patient assigned to Orlistat/SLX-4090 group did not start the assigned treatment due to lack of drugs.

This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment.

Arm/Group Title SLx-4090 Placebo/Orlistat Placebo Orlistat/Placebo Orlistat Placebo /Slx-4090 Orlistat/SLx-4090
Hide Arm/Group Description:

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

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.

SLx-4090 placebo: Given for 4 weeks

Orlistat: Given for 4 weeks

Orlistat placebo 2 capsules, 60mg each three times per day with meals. Slx-4090 4 tablets, 50mg each. three times per day with meals.

Orlistat Placebo: Given for 4 weeks

Slx-4090: Given for 4 weeks

Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals.

Orlistat: Given for 4 weeks

Slx-4090: Given for 4 weeks

Overall Number of Participants Analyzed 1 0 1 0
Mean (Standard Deviation)
Unit of Measure: mg/dL
1156 2946
Time Frame Over a period of 1 year .
Adverse Event Reporting Description

This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment.

Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.

 
Arm/Group Title 1st Intervention Period:SLx-4090 Placebo/Orlistat Placebo 1st Intervention Period:Orlistat/Placebo 1st Intervention Period:Orlistat Placebo /Slx-4090 1st Intervention Period:Orlistat/SLx-4090 2nd Intervention Period:SLx-4090 Placebo/Orlistat Placebo 2nd Intervention Period:Orlistat/Placebo 2nd Intervention Period:Orlistat Placebo /Slx-4090 2nd Intervention Period:Orlistat/SLx-4090 3rd Intervention Period:SLx-4090 Placebo/Orlistat Placebo 3rd Intervention Period:Orlistat/Placebo 3rd Intervention Period:Orlistat Placebo /Slx-4090 3rd Intervention Period:Orlistat/SLx-4090 4th Intervention Period:SLx-4090 Placebo/Orlistat Placebo 4th Intervention Period:Orlistat/Placebo 4th Intervention Period:Orlistat Placebo /Slx-4090 4th Intervention Period:Orlistat/SLx-4090
Hide Arm/Group Description

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

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.

SLx-4090 placebo: Given for 4 weeks

Orlistat: Given for 4 weeks

Orlistat placebo 2 capsules, 60mg each three times per day with meals. Slx-4090 4 tablets, 50mg each. three times per day with meals.

Orlistat Placebo: Given for 4 weeks

Slx-4090: Given for 4 weeks

Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals.

Orlistat: Given for 4 weeks

Slx-4090: Given for 4 weeks

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

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.

SLx-4090 placebo: Given for 4 weeks

Orlistat: Given for 4 weeks

Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals.

Orlistat: Given for 4 weeks

Slx-4090: Given for 4 weeks

Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals.

Orlistat: Given for 4 weeks

Slx-4090: Given for 4 weeks

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

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.

SLx-4090 placebo: Given for 4 weeks

Orlistat: Given for 4 weeks

Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals.

Orlistat: Given for 4 weeks

Slx-4090: Given for 4 weeks

Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals.

Orlistat: Given for 4 weeks

Slx-4090: Given for 4 weeks

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

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.

SLx-4090 placebo: Given for 4 weeks

Orlistat: Given for 4 weeks

Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals.

Orlistat: Given for 4 weeks

Slx-4090: Given for 4 weeks

Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals.

Orlistat: Given for 4 weeks

Slx-4090: Given for 4 weeks

All-Cause Mortality
1st Intervention Period:SLx-4090 Placebo/Orlistat Placebo 1st Intervention Period:Orlistat/Placebo 1st Intervention Period:Orlistat Placebo /Slx-4090 1st Intervention Period:Orlistat/SLx-4090 2nd Intervention Period:SLx-4090 Placebo/Orlistat Placebo 2nd Intervention Period:Orlistat/Placebo 2nd Intervention Period:Orlistat Placebo /Slx-4090 2nd Intervention Period:Orlistat/SLx-4090 3rd Intervention Period:SLx-4090 Placebo/Orlistat Placebo 3rd Intervention Period:Orlistat/Placebo 3rd Intervention Period:Orlistat Placebo /Slx-4090 3rd Intervention Period:Orlistat/SLx-4090 4th Intervention Period:SLx-4090 Placebo/Orlistat Placebo 4th Intervention Period:Orlistat/Placebo 4th Intervention Period:Orlistat Placebo /Slx-4090 4th Intervention Period:Orlistat/SLx-4090
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/2 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/0   0/1 (0.00%)   0/0   0/1 (0.00%)   0/0 
Hide Serious Adverse Events
1st Intervention Period:SLx-4090 Placebo/Orlistat Placebo 1st Intervention Period:Orlistat/Placebo 1st Intervention Period:Orlistat Placebo /Slx-4090 1st Intervention Period:Orlistat/SLx-4090 2nd Intervention Period:SLx-4090 Placebo/Orlistat Placebo 2nd Intervention Period:Orlistat/Placebo 2nd Intervention Period:Orlistat Placebo /Slx-4090 2nd Intervention Period:Orlistat/SLx-4090 3rd Intervention Period:SLx-4090 Placebo/Orlistat Placebo 3rd Intervention Period:Orlistat/Placebo 3rd Intervention Period:Orlistat Placebo /Slx-4090 3rd Intervention Period:Orlistat/SLx-4090 4th Intervention Period:SLx-4090 Placebo/Orlistat Placebo 4th Intervention Period:Orlistat/Placebo 4th Intervention Period:Orlistat Placebo /Slx-4090 4th Intervention Period:Orlistat/SLx-4090
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   1/2 (50.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/0   0/1 (0.00%)   0/0   0/1 (0.00%)   0/0 
Endocrine disorders                                 
Pancreatitis.   0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/0  0/1 (0.00%)  0/0  0/1 (0.00%)  0/0 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1st Intervention Period:SLx-4090 Placebo/Orlistat Placebo 1st Intervention Period:Orlistat/Placebo 1st Intervention Period:Orlistat Placebo /Slx-4090 1st Intervention Period:Orlistat/SLx-4090 2nd Intervention Period:SLx-4090 Placebo/Orlistat Placebo 2nd Intervention Period:Orlistat/Placebo 2nd Intervention Period:Orlistat Placebo /Slx-4090 2nd Intervention Period:Orlistat/SLx-4090 3rd Intervention Period:SLx-4090 Placebo/Orlistat Placebo 3rd Intervention Period:Orlistat/Placebo 3rd Intervention Period:Orlistat Placebo /Slx-4090 3rd Intervention Period:Orlistat/SLx-4090 4th Intervention Period:SLx-4090 Placebo/Orlistat Placebo 4th Intervention Period:Orlistat/Placebo 4th Intervention Period:Orlistat Placebo /Slx-4090 4th Intervention Period:Orlistat/SLx-4090
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   1/1 (100.00%)   1/1 (100.00%)   1/1 (100.00%)   0/1 (0.00%)   0/1 (0.00%)   1/1 (100.00%)   0/2 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/0   0/1 (0.00%)   0/0   0/1 (0.00%)   0/0 
Gastrointestinal disorders                                 
Diarrhea   0/2 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  1/1 (100.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/0  0/1 (0.00%)  0/0  0/1 (0.00%)  0/0 
Abdominal pain   0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/0  0/1 (0.00%)  0/0  0/1 (0.00%)  0/0 
Increased urgency of passing stool   0/2 (0.00%)  1/1 (100.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/0  0/1 (0.00%)  0/0  0/1 (0.00%)  0/0 
Indicates events were collected by systematic assessment

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".

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
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Name/Title: Dr. Abhimanyu Garg
Organization: UT Southwestern Medical Center
Phone: 214-648-8295
EMail: abhimanyu.garg@utsouthwestern.edu
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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