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Completed

NCT Number: NCT01332448

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

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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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Orlistat 120

Drug

Orlistat 120mg tid

Orlistat 60

Drug

Orlistat 60mg tid

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 11, 2011
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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