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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01332448

Enrollment

Registered

2011-04-11

Start date

2010-02-28

Completion date

2010-08-31

Last updated

2017-06-02

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

Conditions

Obesity

Keywords

Xenical, Alli, safety, meta-analysis, liver-function test, Roche, orlistat

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.

Interventions

DRUGOrlistat 120

Orlistat 120mg tid

DRUGOrlistat 60

Orlistat 60mg tid

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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 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

Secondary

Measure	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

Outcome results

None listed

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