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Trial record 2 of 69 for:    ORLISTAT

Orlistat for the Treatment of Type I Hyperlipoproteinemia (T1HLP)

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: NCT02767531
Recruitment Status : Active, not recruiting
First Posted : May 10, 2016
Results First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Abhimanyu Garg, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hyperlipoproteinemia Type I
Hypertriglyceridemia
Intervention Drug: Orlistat
Enrollment 2
Recruitment Details A randomized,open-label, crossover trial with four periods and two sequences (“orlistat” and “off” for 3 months each) was conducted.
Pre-assignment Details  
Arm/Group Title Orlistat Then Off Therapy Off Orlistat Then Orlistat
Hide Arm/Group Description Randomized to Orlistat for first 3 months, then cross over to no therapy for 3 months, followed by repeat sequence of Orlistat for additional 3 months, and no therapy for next 3 months Randomized to no therapy for first 3 months and then cross over to Orlistat for 3 months and then repeat sequence of no therapy for additional 3 months and then Orlistat for next 3 months
Period Title: Period 1
Started 1 [1] 1 [2]
Completed 1 1
Not Completed 0 0
[1]
Orlistat therapy
[2]
Off Orlistat
Period Title: Period 2
Started 1 [1] 1 [2]
Completed 1 1
Not Completed 0 0
[1]
Off Orlistat
[2]
Orlistat Therapy
Period Title: Period 3
Started 1 [1] 1 [2]
Completed 1 1
Not Completed 0 0
[1]
Orlistat Therapy
[2]
Off Orlistat
Period Title: Period 4
Started 1 [1] 1 [2]
Completed 1 1
Not Completed 0 0
[1]
Off Orlistat
[2]
Orlistat Therapy
Arm/Group Title Baseline Features of Patients Enrolled
Hide Arm/Group Description

120 mg of Orlistat will be given 3 times to patients weighing greater than 50 kg and patients weighing less than 40 kg will be given 60 mg of Orlistat 3 times a day for 3 months.

The patients were randomized to receive 3 months of orlistat or no therapy (off), then crossed over to the other arm, and this sequence was then repeated for an additional 6 months

Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
2
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
0
   0.0%
Male
2
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Asian Number Analyzed 2 participants
2
 100.0%
Triglyceride  
Mean (Full Range)
Unit of measure:  mg/dL
Number Analyzed 2 participants
1674
(1611 to 1737)
1.Primary Outcome
Title Fasting Serum Triglycerides
Hide Description Fasting blood samples were collected on three consequetive days at the end of each three month period. Mean values of the three days were calculated.
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
The patients were randomized to receive 3 months of orlistat or no therapy (off), then crossed over to the other arm, and this sequence was then repeated. Because only 2 patients participated, the results are provided per sequence and not per intervention.
Arm/Group Title Orlistat and Then Off Therapy Off Therapy and Then Orlistat
Hide Arm/Group Description:

Randomized to Orlistat for first 3 months, then cross over to no therapy for 3 months, followed by repeat sequence of Orlistat for additional 3 months, and no therapy for next 3 months

120 mg of Orlistat will be given 3 times to patients weighing greater than 50 kg and patients weighing less than 40 kg will be given 60 mg of Orlistat 3 times a day for 3 months.

Randomized to no therapy for first 3 months and then cross over to Orlistat for 3 months and then repeat sequence of no therapy for additional 3 months and then Orlistat for next 3 months
Overall Number of Participants Analyzed 1 1
Mean (Full Range)
Unit of Measure: mg/dL
Period 1
705
(656 to 730)
1827
(1266 to 2320)
Period 2
1511
(1226 to 1750)
1007
(964 to 1040)
Period 3
758
(617 to 876)
3121
(2780 to 3490)
Period 4
1614
(1540 to 1680)
1181
(1122 to 1248)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Orlistat Off Therapy
Hide Arm/Group Description

Each of the two patients, were randomized to receive Orlistat for 3 months in two periods.

Patient 1 took Orlistat 60 mg with the first and second meal and 120 mg with the third meal, whereas Patient 2 took 60 mg of Orlistat 3 times daily with meals.

Each of the two patients, were randomized to "Off therapy" for 3 months in two periods.
All-Cause Mortality
Orlistat Off Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)      0/2 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Orlistat Off Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      0/2 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Orlistat Off Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      0/2 (0.00%)    
Gastrointestinal disorders     
Bloating  [1]  2/2 (100.00%)  2 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Patient1 had a mild increase in passage of gas and bloating, and patient 2 had constipation with mild stool leakage.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Abhimanyu Garg, MD
Organization: UT Southwestern Medical Center
Phone: 2146482895
EMail: abhimanyu.garg@utsouthwestern.edu
Layout table for additonal information
Responsible Party: Abhimanyu Garg, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02767531     History of Changes
Other Study ID Numbers: 012013-042
First Submitted: May 2, 2016
First Posted: May 10, 2016
Results First Submitted: November 19, 2018
Results First Posted: February 1, 2019
Last Update Posted: February 1, 2019