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CompletedNCT01332448Updated Jun 2, 2017

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

An observational study in Obesity, sponsored by GlaxoSmithKline. Completed. Per ClinicalTrials.gov, last updated 2017-06-02.

Sponsored by GlaxoSmithKline · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
1
Sex
All
01

Study 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.

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Conditions studied

  • Obesity

Keywords

  • Xenical
  • Alli
  • safety
  • meta-analysis
  • liver-function test
  • Roche
  • orlistat
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In context

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All clinical trials found by search procedure:

  1. In-house trial repositories at GSK and Roche
  2. EMBASE (which includes MEDLINE) using the terms "orlistat", "Xenical" or "Alli", with "placebo" and "clinical trial"
  3. Recently published meta-analyses found by the search will also be searched for relevant trials

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

Exclusion Criteria:

  1. If cross-over trials are found, data from other than the first period will be excluded.
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
1 participant (actual)

Groups and cohorts

  • Orlistat 120

    Orlistat 120mg tid

    Drug: Orlistat 120

  • Orlistat 60

    Orlistat 60 mg tid

    Drug: Orlistat 60

  • Placebo

    No active drug

    Drug: Orlistat 120 · Drug: Orlistat 60

Interventions

  • DrugOrlistat 120

    Orlistat 120mg tid

  • DrugOrlistat 60

    Orlistat 60mg tid

06

What researchers measure

Primary outcomes

  1. Odds ratio (Orlistat120:Placebo) for subjects experiencing alanine transaminase (ALT) greater than upper limit of normal (ULN)

    Time frame: within one year of starting treatment

  2. Odds ratio (Orlistat120:Placebo) for subjects experiencing total bilirubin (BIL) > ULN

    Time frame: within one year of starting treatment

  3. Odds ratio (Orlistat120:Placebo) for subjects experiencing ALT > ULN for successive measurements more than two weeks apart

    Time frame: within one year of starting treatment

  4. Odds ratio (Orlistat120:Placebo) for subjects experiencing BIL > ULN for successive measurements greater than two weeks apart

    Time frame: within one year of starting treatment

Secondary outcomes

  1. Odds ratio (Orlistat60:Placebo) for subjects experiencing ALT > ULN

    Time frame: within one year of starting treatment

  2. Odds ratio (Orlistat60:Placebo) for subjects experiencing BIL > ULN

    Time frame: within one year of starting treatment

  3. Odds ratio (Orlistat60:Placebo) for subjects experiencing ALT > ULN for successive measurements more than two weeks apart

    Time frame: within one year of starting treatment

  4. Odds ratio (Orlistat60:Placebo) for subjects experiencing BIL > ULN for successive measurements greater than two weeks apart

    Time frame: within one year of starting treatment

07

Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01332448
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Apr 11, 2011
Start date
Feb 2010
Primary completion
Aug 2010
Completion
Aug 2010
Last update
Jun 2, 2017

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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