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Trial record 10 of 69 for:    ORLISTAT

Effect of Orlistat in Body Composition

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ClinicalTrials.gov Identifier: NCT00752726
Recruitment Status : Completed
First Posted : September 15, 2008
Results First Posted : February 7, 2013
Last Update Posted : March 8, 2013
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Obesity
Overweight
Interventions Drug: Orlistat
Drug: Placebo
Enrollment 131
Recruitment Details This multicentric clinical study was conducted in 2 countries; 2 centres in United States of America (USA) and 1 centre in Sweden.
Pre-assignment Details Out of 267 screened participants, 131 were randomized, while 136 participants were considered as screen failures.
Arm/Group Title Orlistat 60 Milligram (mg) Placebo
Hide Arm/Group Description Orlistat 60 mg capsules taken orally with meals 3 times per day Placebo to match orlistat 60 mg capsules taken orally with meals 3 times per day
Period Title: Overall Study
Started 65 66
Safety Population 63 [1] 64 [1]
Intention to Treat (ITT) Population 62 [2] 61 [2]
Completed 54 53
Not Completed 11 13
Reason Not Completed
Lost to Follow-up             2             1
Adverse Event             3             0
Withdrawal by Subject             5             10
Other Reason             1             2
[1]
2 participants were never dosed with the study medication.
[2]
ITT population had atleast 1 post treatment efficacy measurement.
Arm/Group Title Orlistat 60 mg Placebo Total
Hide Arm/Group Description Orlistat 60 mg capsules taken orally with meals 3 times per day. Intent-to-treat (ITT) population was considered for baseline measures. Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day. ITT population was considered for baseline measures. Total of all reporting groups
Overall Number of Baseline Participants 62 61 123
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 62 participants 61 participants 123 participants
42.92  (9.031) 43.84  (11.682) 43.37  (10.397)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 61 participants 123 participants
Female
51
  82.3%
51
  83.6%
102
  82.9%
Male
11
  17.7%
10
  16.4%
21
  17.1%
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 62 participants 61 participants 123 participants
88.10  (10.705) 87.79  (9.354) 87.95  (10.018)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 62 participants 61 participants 123 participants
168.30  (8.275) 168.08  (8.117) 168.19  (8.164)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram per meter square (kg/m^2)
Number Analyzed 62 participants 61 participants 123 participants
31.03  (2.259) 31.04  (2.064) 31.03  (2.155)
Waist Circumference  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 62 participants 61 participants 123 participants
100.10  (7.967) 100.60  (6.892) 100.35  (7.427)
Visceral Abdominal Tissue (VAT) Mass  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 62 participants 61 participants 123 participants
3.75  (1.870) 3.92  (1.806) 3.83  (1.832)
1.Primary Outcome
Title Change From Baseline to Week 24 in Abdominal VAT Mass
Hide Description VAT was measured by the computed tomography (CT) scan.
Time Frame Baseline to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.
Arm/Group Title Orlistat 60 mg Placebo
Hide Arm/Group Description:
Orlistat 60 mg capsules taken orally with meals 3 times per day
Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
Overall Number of Participants Analyzed 55 54
Mean (Standard Deviation)
Unit of Measure: kg
-0.630  (0.6887) -0.403  (0.7249)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Orlistat 60 mg, Placebo
Comments The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0244
Comments P-value was not adjusted for multiple comparisons.
Method ANCOVA
Comments Mean change was adjusted for treatment, baseline VAT and center effect using an ANCOVA model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.263
Confidence Interval (2-Sided) 95%
0.035 to 0.491
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1150
Estimation Comments Adjusted mean difference between Placebo group and Orlistat group was determined. For this primary analysis, only one statistical test was performed and therefore, no multiple comparison adjustment was done.
2.Secondary Outcome
Title Change From Baseline to Week 12 in Abdominal VAT Mass
Hide Description Abdominal VAT mass from baseline to week 12 was measured by CT scan.
Time Frame Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.
Arm/Group Title Orlistat 60 mg Placebo
Hide Arm/Group Description:
Orlistat 60 mg capsules taken orally with meals 3 times per day
Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
Overall Number of Participants Analyzed 55 53
Mean (Standard Deviation)
Unit of Measure: kg
-0.496  (0.4943) -0.351  (0.5904)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Orlistat 60 mg, Placebo
Comments The null hypothesis considered no difference in the change from baseline to week 12 between the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0415
Comments P-value was not adjusted for multiple comparisons.
Method ANCOVA
Comments Mean change was adjusted for the treatment, baseline VAT and center effects using an ANCOVA model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.172
Confidence Interval (2-Sided) 95%
0.007 to 0.337
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0834
Estimation Comments Adjusted mean difference between Placebo group and Orlistat group was determined.
3.Secondary Outcome
Title Change From Baseline to Week 24 in Body Weight
Hide Description Participants were weighed at least twice until two consecutive measurements were within 0.5 kg of each other and the average of the two measurements was recorded.
Time Frame Baseline to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.
Arm/Group Title Orlistat 60 mg Placebo
Hide Arm/Group Description:
Orlistat 60 mg capsules taken orally with meals 3 times per day
Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
Overall Number of Participants Analyzed 54 53
Mean (Standard Deviation)
Unit of Measure: kg
-5.96  (4.743) -3.91  (5.375)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Orlistat 60 mg, Placebo
Comments The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments P-value was not adjusted for multiple comparisons.
Method ANCOVA
Comments Mean change was adjusted for the treatment, baseline weight and center effects, using an ANCOVA model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 1.99
Confidence Interval (2-Sided) 95%
0.25 to 3.74
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.881
Estimation Comments Adjusted mean difference between Placebo group and Orlistat group was determined.
4.Secondary Outcome
Title Change From Baseline to Week 24 in Total Fat Mass
Hide Description Change in total fat mass was calculated from an average of three measurements at each visit from Echo Magnetic Resonance Imaging (EchoMRI).
Time Frame Baseline to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.
Arm/Group Title Orlistat 60 mg Placebo
Hide Arm/Group Description:
Orlistat 60 mg capsules taken orally with meals 3 times per day
Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
Overall Number of Participants Analyzed 54 53
Mean (Standard Deviation)
Unit of Measure: kg
-4.69  (3.691) -3.16  (4.248)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Orlistat 60 mg, Placebo
Comments The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0242
Comments P-value was not adjusted for multiple comparisons.
Method ANCOVA
Comments Mean change was adjusted for the treatment, baseline total fat mass and center effects using an ANCOVA model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 1.642
Confidence Interval (2-Sided) 95%
0.219 to 3.065
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7174
Estimation Comments Adjusted mean difference between placebo group and Orlistat group was determined.
5.Secondary Outcome
Title Change From Baseline to Week 24 in Percentage Body Fat
Hide Description Body fat was assessed through Bioelectrical Impedance Analysis (BIA).
Time Frame Baseline to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.
Arm/Group Title Orlistat 60 mg Placebo
Hide Arm/Group Description:
Orlistat 60 mg capsules taken orally with meals 3 times per day
Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
Overall Number of Participants Analyzed 54 53
Mean (Standard Deviation)
Unit of Measure: Percentage (%) body fat
-1.70  (3.434) -0.38  (4.232)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Orlistat 60 mg, Placebo
Comments The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments P-value was not adjusted for multiple comparisons
Method ANCOVA
Comments Mean was adjusted for the treatment, baseline total fat mass and center effects using an ANCOVA model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 1.47
Confidence Interval (2-Sided) 95%
0.07 to 2.87
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.704
Estimation Comments Adjusted mean difference between placebo group and Orlistat group was evaluated.
6.Secondary Outcome
Title Change From Baseline to Week 24 in Waist Circumference
Hide Description Waist circumference was measured against the skin, without interference from clothing, at the level midway between the lateral lower rib margin and the iliac crest in standing position.
Time Frame Baseline to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.
Arm/Group Title Orlistat 60 mg Placebo
Hide Arm/Group Description:
Orlistat 60 mg capsules taken orally with meals 3 times per day
Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
Overall Number of Participants Analyzed 54 53
Mean (Standard Deviation)
Unit of Measure: cm
-6.65  (0.692) -4.95  (0.704)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Orlistat 60 mg, Placebo
Comments The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.085
Comments P-value was not adjusted for multiple comparisons
Method ANCOVA
Comments Mean change was adjusted for the treatment, baseline waist circumference and center effects, using an ANCOVA model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 1.70
Confidence Interval (2-Sided) 95%
-0.24 to 3.63
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.974
Estimation Comments Adjusted mean difference between Placebo group and Orlistat group was determined.
7.Secondary Outcome
Title Change From Baseline to Week 24 in Percentage Liver Fat
Hide Description For Liver fat, Intrahepatic lipids (IHL) were measured by Magnetic Resonance Spectroscopy (MRS).
Time Frame Baseline to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT subset (participants who had this post-baseline efficacy assessment) from one study site was analysed for this parameter.
Arm/Group Title Orlistat 60 mg Placebo
Hide Arm/Group Description:
Orlistat 60 mg capsules taken orally with meals 3 times per day
Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
Overall Number of Participants Analyzed 9 8
Mean (Standard Deviation)
Unit of Measure: Percentage (%) IHL
-0.0008  (0.00609) -0.0112  (0.03642)
8.Secondary Outcome
Title Change From Baseline to Week 24 in Liver Fat
Hide Description The liver fat was measured by CT scan in Hounsfield Units (HU).
Time Frame Baseline to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.
Arm/Group Title Orlistat 60 mg Placebo
Hide Arm/Group Description:
Orlistat 60 mg capsules taken orally with meals 3 times per day
Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
Overall Number of Participants Analyzed 54 53
Mean (Standard Deviation)
Unit of Measure: Hounsfield Units (HU)
0.06  (0.169) 0.02  (0.174)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Orlistat 60 mg, Placebo
Comments The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3235
Comments P-value was not adjusted for multiple comparisons.
Method ANCOVA
Comments Mean change was adjusted for the treatment, baseline liver fat and center effects, using an ANCOVA model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -0.023
Confidence Interval (2-Sided) 95%
-0.069 to 0.023
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0232
Estimation Comments Adjusted mean difference between placebo group and Orlistat group was evaluated.
9.Secondary Outcome
Title Change From Baseline to Week 24 in Total Calories Expended for Physical Activity
Hide Description Measurement of physical activity from Paffenbarger questionnaire. The number of caloried expended was representation of activity level: Higher calorie counts indicate higher activity
Time Frame Baseline to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.
Arm/Group Title Orlistat 60 mg Placebo
Hide Arm/Group Description:
Orlistat 60 mg capsules taken orally with meals 3 times per day
Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
Overall Number of Participants Analyzed 54 53
Mean (Standard Deviation)
Unit of Measure: Kilocalorie (kcal)/week
-498  (6627) 517  (4873)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Orlistat 60 mg, Placebo
Comments The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments P-value was not adjusted for multiple comparisons
Method ANCOVA
Comments Mean change was adjusted for the treatment, baseline total calories expended and center effects using an ANCOVA model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 783.8
Confidence Interval (2-Sided) 95%
-657.3 to 2224.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 726.54
Estimation Comments Adjusted mean difference between placebo group and Orlistat group was evaluated.
10.Secondary Outcome
Title Change From Baseline to Week 24 in Quality of Life (QoL) Scores.
Hide Description QoL scores were measured using an Impact of Weight Quality of Life (IWQoL) Questionnaire, which scored the responses at a scale of 1 to 5(1, never true, to 5, always true): QoL scales for physical function, self-esteem, sexual life, public distress, and work were evaluated, and summarized in a total score. A higher value indicated a better quality of life.
Time Frame Baseline to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was carried out for the observed ITT population, i.e. ITT subjects who had this post-baseline efficacy assessment.
Arm/Group Title Orlistat 60 mg Placebo
Hide Arm/Group Description:
Orlistat 60 mg capsules taken orally with meals 3 times per day
Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
Overall Number of Participants Analyzed 53 52
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
5.29  (8.009) 8.78  (10.429)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Orlistat 60 mg, Placebo
Comments The null hypothesis considered no difference in the change from baseline to week 24 between the treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2847
Comments P-value was not adjusted for multiple comparisons.
Method ANCOVA
Comments Mean difference was adjusted for the treatment, baseline value and center effects using an ANCOVA model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 1.66
Confidence Interval (2-Sided) 95%
-1.40 to 4.72
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.542
Estimation Comments Adjusted mean difference was calculated as placebo minus orlistat.
11.Secondary Outcome
Title Selectivity Index at Week 24
Time Frame Baseline to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment, only in Orlistat 60 mg group. This analysis was not carried out for placebo group.
Arm/Group Title Orlistat 60 mg
Hide Arm/Group Description:
Orlistat 60 mg capsules taken orally with meals 3 times per day
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: Ratio
1.155
Time Frame All adverse events encountered or spontaneously reported by the participant following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Orlistat 60 mg Placebo
Hide Arm/Group Description Orlistat 60 mg capsules taken orally with meals 3 times per day Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
All-Cause Mortality
Orlistat 60 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Orlistat 60 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/63 (3.17%)      1/64 (1.56%)    
Eye disorders     
Vision blurred   1/63 (1.59%)  1 0/64 (0.00%)  0
Hepatobiliary disorders     
Cholelithiasis   1/63 (1.59%)  1 1/64 (1.56%)  1
Biliary tract disorder   1/63 (1.59%)  1 0/64 (0.00%)  0
Infections and infestations     
Abdominal infection   1/63 (1.59%)  1 0/64 (0.00%)  0
Renal and urinary disorders     
Nephrolithiasis   1/63 (1.59%)  1 0/64 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Orlistat 60 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   57/63 (90.48%)      52/64 (81.25%)    
Gastrointestinal disorders     
Fatty/oily stool   22/63 (34.92%)  36 3/64 (4.69%)  4
Soft stools   14/63 (22.22%)  17 8/64 (12.50%)  10
Flatulence   12/63 (19.05%)  16 5/64 (7.81%)  6
Liquid stools   7/63 (11.11%)  8 5/64 (7.81%)  5
Abdominal pain upper   2/63 (3.17%)  2 6/64 (9.38%)  8
Increased defecation   6/63 (9.52%)  7 2/64 (3.13%)  3
Diarrhoea   2/63 (3.17%)  2 4/64 (6.25%)  5
Fecal urgency   1/63 (1.59%)  2 4/64 (6.25%)  5
Flatus with discharge   5/63 (7.94%)  5 0/64 (0.00%)  0
Nausea   4/63 (6.35%)  4 1/64 (1.56%)  1
Oily spotting   4/63 (6.35%)  4 0/64 (0.00%)  0
Infections and infestations     
Nasopharyngitis   25/63 (39.68%)  29 22/64 (34.38%)  33
Gastroenteritis   2/63 (3.17%)  2 5/64 (7.81%)  7
Influenza   5/63 (7.94%)  5 4/64 (6.25%)  4
Musculoskeletal and connective tissue disorders     
Pain in extremity   2/63 (3.17%)  3 4/64 (6.25%)  4
Nervous system disorders     
Headache   4/63 (6.35%)  5 4/64 (6.25%)  6
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00752726     History of Changes
Other Study ID Numbers: W3600586
First Submitted: September 11, 2008
First Posted: September 15, 2008
Results First Submitted: July 21, 2010
Results First Posted: February 7, 2013
Last Update Posted: March 8, 2013