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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Drug: Orlistat 120
* Drug: Orlistat 60


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The trial must be randomized and placebo-controlled The orlistat dose must be 60mg or 120mg Data on ALT or BIL must be available 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Orlistat 120<br>Orlistat 120mg tid | Drug: Orlistat 120<br>* Orlistat 120mg tid<br>|
| Orlistat 60<br>Orlistat 60 mg tid | Drug: Orlistat 60<br>* Orlistat 60mg tid<br>|
| Placebo<br>No active drug | Drug: Orlistat 120<br>* Orlistat 120mg tid<br>Drug: Orlistat 60<br>* Orlistat 60mg tid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 total bilirubin (BIL) > 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 | 
| Odds ratio (Orlistat120:Placebo) for subjects experiencing BIL > ULN for successive measurements greater than two weeks apart |  | within one year of starting treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xenical, Alli, safety, meta-analysis, liver-function test, Roche, orlistat