Trial · NCT00752726

Effect of Orlistat in Body Composition

NCT00752726, Phase 4, Completed, GlaxoSmithKline; results first posted 2013-02-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effect of Orlistat in Body Composition. Trials, record NCT00752726. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00752726

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effect of Orlistat in Body Composition
NCT number: NCT00752726
Status: Completed
Phases: Phase 4
Enrollment: 131 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Obesity, Overweight
Interventions: Orlistat, Placebo
First posted: 2008-09-15
Last updated: 2013-03-08
Results first posted: 2013-02-07

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 24 in Abdominal VAT Mass	Baseline to week 24	VAT was measured by the computed tomography (CT) scan.
Secondary	Change From Baseline to Week 12 in Abdominal VAT Mass	Baseline to week 12	Abdominal VAT mass from baseline to week 12 was measured by CT scan.
Secondary	Change From Baseline to Week 24 in Body Weight	Baseline to week 24	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.
Secondary	Change From Baseline to Week 24 in Total Fat Mass	Baseline to week 24	Change in total fat mass was calculated from an average of three measurements at each visit from Echo Magnetic Resonance Imaging (EchoMRI).
Secondary	Change From Baseline to Week 24 in Percentage Body Fat	Baseline to week 24	Body fat was assessed through Bioelectrical Impedance Analysis (BIA).
Secondary	Change From Baseline to Week 24 in Waist Circumference	Baseline to week 24	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.
Secondary	Change From Baseline to Week 24 in Percentage Liver Fat	Baseline to week 24	For Liver fat, Intrahepatic lipids (IHL) were measured by Magnetic Resonance Spectroscopy (MRS).
Secondary	Change From Baseline to Week 24 in Liver Fat	Baseline to week 24	The liver fat was measured by CT scan in Hounsfield Units (HU).
Secondary	Change From Baseline to Week 24 in Total Calories Expended for Physical Activity	Baseline to week 24	Measurement of physical activity from Paffenbarger questionnaire. The number of caloried expended was representation of activity level: Higher calorie counts indicate higher activity
Secondary	Change From Baseline to Week 24 in Quality of Life (QoL) Scores.	Baseline to week 24	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.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Week 24 in Abdominal VAT Mass	Baseline to week 24	This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.	kg	MEAN
SECONDARY	Change From Baseline to Week 12 in Abdominal VAT Mass	Baseline to week 12	This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.	kg	MEAN
SECONDARY	Change From Baseline to Week 24 in Body Weight	Baseline to week 24	This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.	kg	MEAN
SECONDARY	Change From Baseline to Week 24 in Total Fat Mass	Baseline to week 24	This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.	kg	MEAN
SECONDARY	Change From Baseline to Week 24 in Percentage Body Fat	Baseline to week 24	This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.	Percentage (%) body fat	MEAN
SECONDARY	Change From Baseline to Week 24 in Waist Circumference	Baseline to week 24	This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.	cm	MEAN
SECONDARY	Change From Baseline to Week 24 in Percentage Liver Fat	Baseline to week 24	ITT subset (participants who had this post-baseline efficacy assessment) from one study site was analysed for this parameter.	Percentage (%) IHL	MEAN
SECONDARY	Change From Baseline to Week 24 in Liver Fat	Baseline to week 24	This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.	Hounsfield Units (HU)	MEAN
SECONDARY	Change From Baseline to Week 24 in Total Calories Expended for Physical Activity	Baseline to week 24	This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.	Kilocalorie (kcal)/week	MEAN
SECONDARY	Change From Baseline to Week 24 in Quality of Life (QoL) Scores.	Baseline to week 24	This analysis was carried out for the observed ITT population, i.e. ITT subjects who had this post-baseline efficacy assessment.	Score on a Scale	MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group21

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline to Week 24 in Abdominal VAT Mass	Orlistat 60 mg	-0.630	Standard Deviation 0.6887	kg
Change From Baseline to Week 24 in Abdominal VAT Mass	Placebo	-0.403	Standard Deviation 0.7249	kg
Change From Baseline to Week 12 in Abdominal VAT Mass	Orlistat 60 mg	-0.496	Standard Deviation 0.4943	kg
Change From Baseline to Week 12 in Abdominal VAT Mass	Placebo	-0.351	Standard Deviation 0.5904	kg
Change From Baseline to Week 24 in Body Weight	Orlistat 60 mg	-5.96	Standard Deviation 4.743	kg
Change From Baseline to Week 24 in Body Weight	Placebo	-3.91	Standard Deviation 5.375	kg
Change From Baseline to Week 24 in Total Fat Mass	Orlistat 60 mg	-4.69	Standard Deviation 3.691	kg
Change From Baseline to Week 24 in Total Fat Mass	Placebo	-3.16	Standard Deviation 4.248	kg
Change From Baseline to Week 24 in Percentage Body Fat	Orlistat 60 mg	-1.70	Standard Deviation 3.434	Percentage (%) body fat
Change From Baseline to Week 24 in Percentage Body Fat	Placebo	-0.38	Standard Deviation 4.232	Percentage (%) body fat

1 to 10 of 21Source ClinicalTrials.gov

See all 21 results by group

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Orlistat 60 Milligram (mg)	65
Overall Study	STARTED	Placebo	66
Overall Study	Safety Population	Orlistat 60 Milligram (mg)	63
Overall Study	Safety Population	Placebo	64
Overall Study	Intention to Treat (ITT) Population	Orlistat 60 Milligram (mg)	62
Overall Study	Intention to Treat (ITT) Population	Placebo	61
Overall Study	COMPLETED	Orlistat 60 Milligram (mg)	54
Overall Study	COMPLETED	Placebo	53
Overall Study	NOT COMPLETED	Orlistat 60 Milligram (mg)	11
Overall Study	NOT COMPLETED	Placebo	13

Source ClinicalTrials.gov

Adverse events42

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Fatty/oily stool	Gastrointestinal disorders	Orlistat 60 mg	22	63	36
other	Fatty/oily stool	Gastrointestinal disorders	Placebo	3	64	4
other	Soft stools	Gastrointestinal disorders	Orlistat 60 mg	14	63	17
other	Soft stools	Gastrointestinal disorders	Placebo	8	64	10
other	Flatulence	Gastrointestinal disorders	Orlistat 60 mg	12	63	16
other	Flatulence	Gastrointestinal disorders	Placebo	5	64	6
other	Liquid stools	Gastrointestinal disorders	Orlistat 60 mg	7	63	8
other	Liquid stools	Gastrointestinal disorders	Placebo	5	64	5
other	Abdominal pain upper	Gastrointestinal disorders	Orlistat 60 mg	2	63	2
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	6	64	8

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Orlistat 60 mg
Total, all-cause mortality	Placebo
Total, other adverse events	Orlistat 60 mg	57	63
Total, other adverse events	Placebo	52	64
Total, serious adverse events	Orlistat 60 mg	2	63
Total, serious adverse events	Placebo	1	64

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21720429	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Orlistat 60 mg vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00752726

GET https://conductscience.org/api/trials/v1/NCT00752726/results?page=2

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