Trial · NCT00001723

Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases

NCT00001723, Phase 2, Completed, Jack Yanovski; results first posted 2012-12-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases. Trials, record NCT00001723. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00001723

On this page

Trial

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

Title: Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases
NCT number: NCT00001723
Status: Completed
Phases: Phase 2
Enrollment: 200 participants, actual
Lead sponsor: Jack Yanovski
Conditions: Diabetes Mellitus, Hypertension, Metabolic Disease, Obesity, Sleep Apnea Syndrome
Interventions: Orlistat, Placebo
First posted: 1999-11-04
Last updated: 2012-12-18
Results first posted: 2012-12-18

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Change in BMI Standard Deviation Score	baseline to 6 months	Body Mass index standard deviation score calculated for age and sex according to Centers for Disease Control standards. See: Kuczmarski RJ, Ogden CL, Guo SS, Grummer-Strawn LM, Flegal KM, Mei Z et al. 2000 CDC Growth Charts for the United States: methods and development. Vital Health Stat 11 2002; (246): 1-190.
Secondary	Change in Body Weight	baseline to 6 months	Weight in kg
Secondary	Change in Body Mass Index	baseline to 6 months	BMI is calculated in kg/m2. Change from baseline to 6 months of treatment
Secondary	Change in Body Fat (kg)	baseline to 6 months	body fat distribution measures obtained from Dual-energy X-ray Absorptiometry (DEXA)
Secondary	Effect of Race on Change in Weight (kg)	baseline to 6 months	Difference in change of weight in kg according to race (Non-Hispanic White versus Non-Hispanic Black)

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in BMI Standard Deviation Score	baseline to 6 months	Multiple imputation analysis	Standard Deviation Score	MEAN
SECONDARY	Change in Body Weight	baseline to 6 months	Multiple imputation analysis	kg	MEAN
SECONDARY	Change in Body Mass Index	baseline to 6 months	Muliple imputation analysis	kg per square meter	MEAN
SECONDARY	Change in Body Fat (kg)	baseline to 6 months	Multiple Imputation analysis	kg	MEAN
SECONDARY	Effect of Race on Change in Weight (kg)	baseline to 6 months	Multiple imputation analysis	kg	MEAN

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Value	Spread	Units
Change in BMI Standard Deviation Score	Orlistat	-0.12	Standard Error 0.02	Standard Deviation Score
Change in BMI Standard Deviation Score	Placebo	-0.06	Standard Error 0.02	Standard Deviation Score
Change in Body Weight	Orlistat	-2.9	Standard Error 0.7	kg
Change in Body Weight	Placebo	-0.6	Standard Error 0.7	kg
Change in Body Mass Index	Orlistat	-1.44	Standard Error 0.26	kg per square meter
Change in Body Mass Index	Placebo	-0.50	Standard Error 0.20	kg per square meter
Change in Body Fat (kg)	Orlistat	-3.2	Standard Error 0.55	kg
Change in Body Fat (kg)	Placebo	-1.7	Standard Error 0.53	kg
Effect of Race on Change in Weight (kg)	Orlistat - Non-Hispanic Blacks	-2.126	Standard Error 0.812	kg
Effect of Race on Change in Weight (kg)	Orlistat - Non- Hispanic Whites	-3.742	Standard Error 1.046	kg

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Orlistat	100
Overall Study	STARTED	Placebo	100
Overall Study	COMPLETED	Orlistat	87
Overall Study	COMPLETED	Placebo	84
Overall Study	NOT COMPLETED	Orlistat	13
Overall Study	NOT COMPLETED	Placebo	16

Source ClinicalTrials.gov

Adverse events96

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
other	ear disorders (otitis, earache, ear pain)	Ear and labyrinth disorders	Orlistat	7	100
other	ear disorders (otitis, earache, ear pain)	Ear and labyrinth disorders	Placebo	7	100
other	eye disorders (change in vision, conjunctivitis, styes)	Eye disorders	Orlistat	8	100
other	eye disorders (change in vision, conjunctivitis, styes)	Eye disorders	Placebo	9	100
other	abdominal pain or cramping	Gastrointestinal disorders	Orlistat	16	100
other	abdominal pain or cramping	Gastrointestinal disorders	Placebo	21	100
other	bloating or gas	Gastrointestinal disorders	Orlistat	18	100
other	bloating or gas	Gastrointestinal disorders	Placebo	5	100
other	BORBORYGMI	Gastrointestinal disorders	Orlistat	6	100
other	BORBORYGMI	Gastrointestinal disorders	Placebo	2	100

1 to 10 of 96Source ClinicalTrials.gov

See all 96 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Orlistat
Total, all-cause mortality	Placebo
Total, other adverse events	Orlistat	95	100
Total, other adverse events	Placebo	94	100
Total, serious adverse events	Orlistat	0	100
Total, serious adverse events	Placebo	2	100

Source ClinicalTrials.gov

Papers11

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
1406836	BACKGROUND	PubMed
7627244	BACKGROUND	PubMed
8022039	BACKGROUND	PubMed
12105286	RESULT	PubMed
12126214	RESULT	PubMed
15112907	RESULT	PubMed
15956632	BACKGROUND	PubMed
26210388	DERIVED	PubMed
29718281	DERIVED	PubMed
33059389	DERIVED	PubMed

1 to 10 of 11

See all 11 papers

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 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/NCT00001723

GET https://conductscience.org/api/trials/v1/NCT00001723/events?page=2

API reference For AI assistants