A Study of Xenical (Orlistat) in Overweight and Obese Adolescents

Open-label Comparative Randomized Study of the Efficacy and Safety of Orlistat (Xenical) in Complex Therapy of Obesity and Metabolic Disorders in Adolescents

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00940628

Enrollment

Registered

2009-07-16

Start date

2008-04-30

Completion date

2010-09-30

Last updated

2016-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

This 2 arm study will assess the effect of Xenical on body mass index (BMI)in obese or overweight adolescents. Patients will be randomised into one of 2 groups; both groups will undergo a regimen of mildly hypocaloric diet and physical exercise, but one group will also receive Xenical 120mg po tid. The anticipated time on study treatment is 1 year, and the target sample size is \<100 individuals.

Interventions

BEHAVIORALDiet and Exercise

mildly hypocaloric diet and physical exercise

DRUGorlistat [Xenical]

120mg po tid

Study design

Allocation

NON_RANDOMIZED

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 14 Years

Healthy volunteers

Inclusion criteria

* adolescent patients, 12-14 years of age * overweight or obese

Exclusion criteria

* age \<12 or \>14 years * BMI in normal range

Design outcomes

Primary

Measure	Time frame
Change in BMI	At each clinic visit, every 4 weeks

Secondary

Measure	Time frame
Adverse events, laboratory parameters	At each clinic visit, every 4 weeks

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026