Meta-analysis of Orlistat Laboratory Data From Placebo-controlled Clinical Trials

Completed

• Conditions: Obesity
• Interventions: Drug: Orlistat 120; Drug: Orlistat 60

• Registration Number: NCT01332448
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Roche and GSK will carry out a meta-analysis of liver function data from trials of orlistat to establish whether there is any indication of liver toxicity. The motivation is a cumulative assessment of drug-induced liver injury (DILI) conducted by the FDA following spontaneous reports of liver toxicity in people taking Xenical or Alli.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-11
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-01
• Last Update Posted: 2017-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

1. The trial must be randomized and placebo-controlled
2. The orlistat dose must be 60mg or 120mg
3. Data on ALT or BIL must be available
4. The nominal treatment period must be 16 weeks or longer

Exclusion Criteria

1. If cross-over trials are found, data from other than the first period will be excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Placebo	Orlistat 120	No active drug
Orlistat 120	Orlistat 120	Orlistat 120mg tid
Orlistat 60	Orlistat 60	Orlistat 60 mg tid
Placebo	Orlistat 60	No active drug

Primary Outcome Measures

Name	Time	Method
Odds ratio (Orlistat120:Placebo) for subjects experiencing BIL > ULN for successive measurements greater than two weeks apart	within one year of starting treatment
Odds ratio (Orlistat120:Placebo) for subjects experiencing total bilirubin (BIL) > ULN	within one year of starting treatment
Odds ratio (Orlistat120:Placebo) for subjects experiencing alanine transaminase (ALT) greater than upper limit of normal (ULN)	within one year of starting treatment
Odds ratio (Orlistat120:Placebo) for subjects experiencing ALT > ULN for successive measurements more than two weeks apart	within one year of starting treatment

Secondary Outcome Measures

Name	Time	Method
Odds ratio (Orlistat60:Placebo) for subjects experiencing ALT > ULN for successive measurements more than two weeks apart	within one year of starting treatment
Odds ratio (Orlistat60:Placebo) for subjects experiencing BIL > ULN for successive measurements greater than two weeks apart	within one year of starting treatment
Odds ratio (Orlistat60:Placebo) for subjects experiencing ALT > ULN	within one year of starting treatment
Odds ratio (Orlistat60:Placebo) for subjects experiencing BIL > ULN	within one year of starting treatment