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Effect of Orlistat in Body Composition

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00752726
First received: September 11, 2008
Last updated: February 28, 2013
Last verified: February 2013
History of Changes
Results First Received: July 21, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Obesity
Overweight
Interventions: Drug: Orlistat
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 267 screened participants, 131 were randomized, while 136 participants were considered as screen failures.

Reporting Groups
  Description
Orlistat 60 Milligram (mg) Orlistat 60 mg capsules taken orally with meals 3 times per day
Placebo Placebo to match orlistat 60 mg capsules taken orally with meals 3 times per day

Participant Flow:   Overall Study
    Orlistat 60 Milligram (mg)     Placebo  
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  
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.



  Baseline Characteristics
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Reporting Groups
  Description
Orlistat 60 mg Orlistat 60 mg capsules taken orally with meals 3 times per day. Intent-to-treat (ITT) population was considered for baseline measures.
Placebo Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day. ITT population was considered for baseline measures.
Total Total of all reporting groups

Baseline Measures
    Orlistat 60 mg     Placebo     Total  
Number of Participants  
[units: participants]
 		  62     61     123  
Age  
[units: Year]
Mean ± Standard Deviation 		  42.92  ± 9.031     43.84  ± 11.682     43.37  ± 10.397  
Gender  
[units: Participants]
 		     
Female     51     51     102  
Male     11     10     21  
Body Weight  
[units: Kilogram (kg)]
Mean ± Standard Deviation 		  88.10  ± 10.705     87.79  ± 9.354     87.95  ± 10.018  
Height  
[units: Centimeter (cm)]
Mean ± Standard Deviation 		  168.30  ± 8.275     168.08  ± 8.117     168.19  ± 8.164  
Body Mass Index (BMI)  
[units: Kilogram per meter square (kg/m^2)]
Mean ± Standard Deviation 		  31.03  ± 2.259     31.04  ± 2.064     31.03  ± 2.155  
Waist Circumference  
[units: cm]
Mean ± Standard Deviation 		  100.10  ± 7.967     100.60  ± 6.892     100.35  ± 7.427  
Visceral Abdominal Tissue (VAT) Mass  
[units: kg]
Mean ± Standard Deviation 		  3.75  ± 1.870     3.92  ± 1.806     3.83  ± 1.832  



  Outcome Measures
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1.  Primary:   Change From Baseline to Week 24 in Abdominal VAT Mass   [ Time Frame: Baseline to week 24 ]
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2.  Secondary:   Change From Baseline to Week 12 in Abdominal VAT Mass   [ Time Frame: Baseline to week 12 ]
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3.  Secondary:   Change From Baseline to Week 24 in Body Weight   [ Time Frame: Baseline to week 24 ]
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4.  Secondary:   Change From Baseline to Week 24 in Total Fat Mass   [ Time Frame: Baseline to week 24 ]
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5.  Secondary:   Change From Baseline to Week 24 in Percentage Body Fat   [ Time Frame: Baseline to week 24 ]
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6.  Secondary:   Change From Baseline to Week 24 in Waist Circumference   [ Time Frame: Baseline to week 24 ]
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7.  Secondary:   Change From Baseline to Week 24 in Percentage Liver Fat   [ Time Frame: Baseline to week 24 ]
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8.  Secondary:   Change From Baseline to Week 24 in Liver Fat   [ Time Frame: Baseline to week 24 ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline to Week 24 in Total Calories Expended for Physical Activity   [ Time Frame: Baseline to week 24 ]
  Show Outcome Measure 9

10.  Secondary:   Change From Baseline to Week 24 in Quality of Life (QoL) Scores.   [ Time Frame: Baseline to week 24 ]
  Show Outcome Measure 10

11.  Secondary:   Selectivity Index at Week 24   [ Time Frame: Baseline to week 24 ]
  Show Outcome Measure 11


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00752726     History of Changes
Other Study ID Numbers: W3600586
Study First Received: September 11, 2008
Results First Received: July 21, 2010
Last Updated: February 28, 2013
Health Authority: United States: Institutional Review Board