Trial Outcomes & Findings for Effect of Orlistat in Body Composition (NCT NCT00752726)
NCT ID: NCT00752726
Last Updated: 2013-03-08
Results Overview
VAT was measured by the computed tomography (CT) scan.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
131 participants
Primary outcome timeframe
Baseline to week 24
Results posted on
2013-03-08
Participant Flow
This multicentric clinical study was conducted in 2 countries; 2 centres in United States of America (USA) and 1 centre in Sweden.
Out of 267 screened participants, 131 were randomized, while 136 participants were considered as screen failures.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
66
|
|
Overall Study
Safety Population
|
63
|
64
|
|
Overall Study
Intention to Treat (ITT) Population
|
62
|
61
|
|
Overall Study
COMPLETED
|
54
|
53
|
|
Overall Study
NOT COMPLETED
|
11
|
13
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
10
|
|
Overall Study
Other Reason
|
1
|
2
|
Baseline Characteristics
Effect of Orlistat in Body Composition
Baseline characteristics by cohort
| Measure |
Orlistat 60 mg
n=62 Participants
Orlistat 60 mg capsules taken orally with meals 3 times per day. Intent-to-treat (ITT) population was considered for baseline measures.
|
Placebo
n=61 Participants
Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day. ITT population was considered for baseline measures.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
42.92 Year
STANDARD_DEVIATION 9.031 • n=5 Participants
|
43.84 Year
STANDARD_DEVIATION 11.682 • n=7 Participants
|
43.37 Year
STANDARD_DEVIATION 10.397 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Body Weight
|
88.10 Kilogram (kg)
STANDARD_DEVIATION 10.705 • n=5 Participants
|
87.79 Kilogram (kg)
STANDARD_DEVIATION 9.354 • n=7 Participants
|
87.95 Kilogram (kg)
STANDARD_DEVIATION 10.018 • n=5 Participants
|
|
Height
|
168.30 Centimeter (cm)
STANDARD_DEVIATION 8.275 • n=5 Participants
|
168.08 Centimeter (cm)
STANDARD_DEVIATION 8.117 • n=7 Participants
|
168.19 Centimeter (cm)
STANDARD_DEVIATION 8.164 • n=5 Participants
|
|
Body Mass Index (BMI)
|
31.03 Kilogram per meter square (kg/m^2)
STANDARD_DEVIATION 2.259 • n=5 Participants
|
31.04 Kilogram per meter square (kg/m^2)
STANDARD_DEVIATION 2.064 • n=7 Participants
|
31.03 Kilogram per meter square (kg/m^2)
STANDARD_DEVIATION 2.155 • n=5 Participants
|
|
Waist Circumference
|
100.10 cm
STANDARD_DEVIATION 7.967 • n=5 Participants
|
100.60 cm
STANDARD_DEVIATION 6.892 • n=7 Participants
|
100.35 cm
STANDARD_DEVIATION 7.427 • n=5 Participants
|
|
Visceral Abdominal Tissue (VAT) Mass
|
3.75 kg
STANDARD_DEVIATION 1.870 • n=5 Participants
|
3.92 kg
STANDARD_DEVIATION 1.806 • n=7 Participants
|
3.83 kg
STANDARD_DEVIATION 1.832 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 24Population: This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.
VAT was measured by the computed tomography (CT) scan.
Outcome measures
| Measure |
Orlistat 60 mg
n=55 Participants
Orlistat 60 mg capsules taken orally with meals 3 times per day
|
Placebo
n=54 Participants
Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
|
|---|---|---|
|
Change From Baseline to Week 24 in Abdominal VAT Mass
|
-0.630 kg
Standard Deviation 0.6887
|
-0.403 kg
Standard Deviation 0.7249
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.
Abdominal VAT mass from baseline to week 12 was measured by CT scan.
Outcome measures
| Measure |
Orlistat 60 mg
n=55 Participants
Orlistat 60 mg capsules taken orally with meals 3 times per day
|
Placebo
n=53 Participants
Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
|
|---|---|---|
|
Change From Baseline to Week 12 in Abdominal VAT Mass
|
-0.496 kg
Standard Deviation 0.4943
|
-0.351 kg
Standard Deviation 0.5904
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.
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.
Outcome measures
| Measure |
Orlistat 60 mg
n=54 Participants
Orlistat 60 mg capsules taken orally with meals 3 times per day
|
Placebo
n=53 Participants
Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
|
|---|---|---|
|
Change From Baseline to Week 24 in Body Weight
|
-5.96 kg
Standard Deviation 4.743
|
-3.91 kg
Standard Deviation 5.375
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.
Change in total fat mass was calculated from an average of three measurements at each visit from Echo Magnetic Resonance Imaging (EchoMRI).
Outcome measures
| Measure |
Orlistat 60 mg
n=54 Participants
Orlistat 60 mg capsules taken orally with meals 3 times per day
|
Placebo
n=53 Participants
Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
|
|---|---|---|
|
Change From Baseline to Week 24 in Total Fat Mass
|
-4.69 kg
Standard Deviation 3.691
|
-3.16 kg
Standard Deviation 4.248
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.
Body fat was assessed through Bioelectrical Impedance Analysis (BIA).
Outcome measures
| Measure |
Orlistat 60 mg
n=54 Participants
Orlistat 60 mg capsules taken orally with meals 3 times per day
|
Placebo
n=53 Participants
Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
|
|---|---|---|
|
Change From Baseline to Week 24 in Percentage Body Fat
|
-1.70 Percentage (%) body fat
Standard Deviation 3.434
|
-0.38 Percentage (%) body fat
Standard Deviation 4.232
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.
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.
Outcome measures
| Measure |
Orlistat 60 mg
n=54 Participants
Orlistat 60 mg capsules taken orally with meals 3 times per day
|
Placebo
n=53 Participants
Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
|
|---|---|---|
|
Change From Baseline to Week 24 in Waist Circumference
|
-6.65 cm
Standard Deviation 0.692
|
-4.95 cm
Standard Deviation 0.704
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: ITT subset (participants who had this post-baseline efficacy assessment) from one study site was analysed for this parameter.
For Liver fat, Intrahepatic lipids (IHL) were measured by Magnetic Resonance Spectroscopy (MRS).
Outcome measures
| Measure |
Orlistat 60 mg
n=9 Participants
Orlistat 60 mg capsules taken orally with meals 3 times per day
|
Placebo
n=8 Participants
Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
|
|---|---|---|
|
Change From Baseline to Week 24 in Percentage Liver Fat
|
-0.0008 Percentage (%) IHL
Standard Deviation 0.00609
|
-0.0112 Percentage (%) IHL
Standard Deviation 0.03642
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.
The liver fat was measured by CT scan in Hounsfield Units (HU).
Outcome measures
| Measure |
Orlistat 60 mg
n=54 Participants
Orlistat 60 mg capsules taken orally with meals 3 times per day
|
Placebo
n=53 Participants
Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
|
|---|---|---|
|
Change From Baseline to Week 24 in Liver Fat
|
0.06 Hounsfield Units (HU)
Standard Deviation 0.169
|
0.02 Hounsfield Units (HU)
Standard Deviation 0.174
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.
Measurement of physical activity from Paffenbarger questionnaire. The number of caloried expended was representation of activity level: Higher calorie counts indicate higher activity
Outcome measures
| Measure |
Orlistat 60 mg
n=54 Participants
Orlistat 60 mg capsules taken orally with meals 3 times per day
|
Placebo
n=53 Participants
Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
|
|---|---|---|
|
Change From Baseline to Week 24 in Total Calories Expended for Physical Activity
|
-498 Kilocalorie (kcal)/week
Standard Deviation 6627
|
517 Kilocalorie (kcal)/week
Standard Deviation 4873
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: This analysis was carried out for the observed ITT population, i.e. ITT subjects who had this post-baseline efficacy assessment.
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.
Outcome measures
| Measure |
Orlistat 60 mg
n=53 Participants
Orlistat 60 mg capsules taken orally with meals 3 times per day
|
Placebo
n=52 Participants
Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
|
|---|---|---|
|
Change From Baseline to Week 24 in Quality of Life (QoL) Scores.
|
5.29 Score on a Scale
Standard Deviation 8.009
|
8.78 Score on a Scale
Standard Deviation 10.429
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: 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.
The selectivity index (SI) was used as a measure of orlistat's ability to target abdominal VAT loss compared to total adipose tissue lost. SI was calculated using the following equation: Mean % change in VAT divided by Mean % change in total fat mass.
Outcome measures
| Measure |
Orlistat 60 mg
n=54 Participants
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
|
|---|---|---|
|
Selectivity Index at Week 24
|
1.155 Ratio
|
—
|
Adverse Events
Orlistat 60 mg
Serious events: 2 serious events
Other events: 57 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Orlistat 60 mg
n=63 participants at risk
Orlistat 60 mg capsules taken orally with meals 3 times per day
|
Placebo
n=64 participants at risk
Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
|
|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
1.6%
1/63 • Number of events 1 • 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
|
1.6%
1/64 • Number of events 1 • 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
|
|
Hepatobiliary disorders
Biliary tract disorder
|
1.6%
1/63 • Number of events 1 • 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
|
0.00%
0/64 • 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
|
|
Eye disorders
Vision blurred
|
1.6%
1/63 • Number of events 1 • 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
|
0.00%
0/64 • 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
|
|
Infections and infestations
Abdominal infection
|
1.6%
1/63 • Number of events 1 • 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
|
0.00%
0/64 • 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
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.6%
1/63 • Number of events 1 • 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
|
0.00%
0/64 • 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
|
Other adverse events
| Measure |
Orlistat 60 mg
n=63 participants at risk
Orlistat 60 mg capsules taken orally with meals 3 times per day
|
Placebo
n=64 participants at risk
Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
|
|---|---|---|
|
Gastrointestinal disorders
Fatty/oily stool
|
34.9%
22/63 • Number of events 36 • 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
|
4.7%
3/64 • Number of events 4 • 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
|
|
Gastrointestinal disorders
Soft stools
|
22.2%
14/63 • Number of events 17 • 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
|
12.5%
8/64 • Number of events 10 • 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
|
|
Gastrointestinal disorders
Flatulence
|
19.0%
12/63 • Number of events 16 • 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
|
7.8%
5/64 • Number of events 6 • 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
|
|
Gastrointestinal disorders
Liquid stools
|
11.1%
7/63 • Number of events 8 • 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
|
7.8%
5/64 • Number of events 5 • 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
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.2%
2/63 • Number of events 2 • 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
|
9.4%
6/64 • Number of events 8 • 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
|
|
Gastrointestinal disorders
Increased defecation
|
9.5%
6/63 • Number of events 7 • 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
|
3.1%
2/64 • Number of events 3 • 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
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
2/63 • Number of events 2 • 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
|
6.2%
4/64 • Number of events 5 • 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
|
|
Gastrointestinal disorders
Fecal urgency
|
1.6%
1/63 • Number of events 2 • 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
|
6.2%
4/64 • Number of events 5 • 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
|
|
Gastrointestinal disorders
Flatus with discharge
|
7.9%
5/63 • Number of events 5 • 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
|
0.00%
0/64 • 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
|
|
Gastrointestinal disorders
Nausea
|
6.3%
4/63 • Number of events 4 • 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
|
1.6%
1/64 • Number of events 1 • 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
|
|
Gastrointestinal disorders
Oily spotting
|
6.3%
4/63 • Number of events 4 • 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
|
0.00%
0/64 • 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
|
|
Infections and infestations
Nasopharyngitis
|
39.7%
25/63 • Number of events 29 • 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
|
34.4%
22/64 • Number of events 33 • 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
|
|
Infections and infestations
Gastroenteritis
|
3.2%
2/63 • Number of events 2 • 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
|
7.8%
5/64 • Number of events 7 • 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
|
|
Infections and infestations
Influenza
|
7.9%
5/63 • Number of events 5 • 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
|
6.2%
4/64 • Number of events 4 • 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
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.2%
2/63 • Number of events 3 • 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
|
6.2%
4/64 • Number of events 4 • 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
|
|
Nervous system disorders
Headache
|
6.3%
4/63 • Number of events 5 • 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
|
6.2%
4/64 • Number of events 6 • 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
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER