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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Obesity

Treatments: Drug: Orlistat 60; Drug: Orlistat 120

Study type: Observational

Funder types: Industry

Identifiers

NCT01332448

114237

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Volunteers: No 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.

Trial design

1 participants in 3 patient groups

Orlistat 120

Description:

Orlistat 120mg tid

Treatment:

Drug: Orlistat 120

Orlistat 60

Description:

Orlistat 60 mg tid

Treatment:

Drug: Orlistat 60

Placebo

Description:

No active drug

Treatment:

Drug: Orlistat 120

Drug: Orlistat 60