ObesityNCT01332448
Meta-analysis of Orlistat Laboratory Data From Placebo-controlled Clinical Trials
An observational study of Obesity, run by GlaxoSmithKline.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity
- What is being tested?
- Orlistat 120 and Orlistat 60
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 1. If cross-over trials are found, data from other than the first period will be excluded.
About this study
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.
- Conditions
- Obesity
- Being tested
- Orlistat 120, Orlistat 60
- Keywords
- Xenical, Alli, safety, meta-analysis, liver-function test, Roche, orlistat
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orlistat 120Drug
Orlistat 120mg tid
Orlistat 60Drug
Orlistat 60mg tid
| Study group | Role | What they receive |
|---|---|---|
| Orlistat 120 | Orlistat 120mg tid Receives: Drug: Orlistat 120 | |
| Orlistat 60 | Orlistat 60 mg tid Receives: Drug: Orlistat 60 | |
| Placebo | No active drug Receives: Drug: Orlistat 120; Drug: Orlistat 60 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Odds ratio (Orlistat120:Placebo) for subjects experiencing alanine transaminase (ALT) greater than upper limit of normal (ULN)
Measured: within one year of starting treatment
Odds ratio (Orlistat120:Placebo) for subjects experiencing total bilirubin (BIL) > ULN
Measured: within one year of starting treatment
Odds ratio (Orlistat120:Placebo) for subjects experiencing ALT > ULN for successive measurements more than two weeks apart
Measured: within one year of starting treatment
Odds ratio (Orlistat120:Placebo) for subjects experiencing BIL > ULN for successive measurements greater than two weeks apart
Measured: within one year of starting treatment
Secondary outcomes (4)
Odds ratio (Orlistat60:Placebo) for subjects experiencing ALT > ULN
Measured: within one year of starting treatment
Odds ratio (Orlistat60:Placebo) for subjects experiencing BIL > ULN
Measured: within one year of starting treatment
Odds ratio (Orlistat60:Placebo) for subjects experiencing ALT > ULN for successive measurements more than two weeks apart
Measured: within one year of starting treatment
Odds ratio (Orlistat60:Placebo) for subjects experiencing BIL > ULN for successive measurements greater than two weeks apart
Measured: within one year of starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startFeb 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332448
- Sponsor's protocol ID
- 114237
- Status last verified
- Jun 2017
- First submitted
- 7 Apr 2011
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meta-analysis of Orlistat Laboratory Data From Placebo-controlled Clinical Trials
- ClinicalTrials.gov ID
- NCT01332448
- Acronym / sponsor ID
- 114237
- Conditions
- Obesity
- Keywords
- Xenical, Alli, safety, meta-analysis, liver-function test, Roche, orlistat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 11 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Orlistat 120 | – | Drug: Orlistat 120Orlistat 120mg tid |
| Orlistat 60 | – | Drug: Orlistat 60Orlistat 60 mg tid |
| Placebo | – | Drug: Orlistat 120, Drug: Orlistat 60No active drug |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 1. If cross-over trials are found, data from other than the first period will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orlistat 120Orlistat 120mg tid | Drug | Orlistat 120, Placebo |
| Orlistat 60Orlistat 60mg tid | Drug | Orlistat 60, Placebo |
Primary outcome
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
Odds ratio (Orlistat120:Placebo) for subjects experiencing total bilirubin (BIL) > ULN
Time frame: within one year of starting treatment
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
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
4 secondary outcomes
Odds ratio (Orlistat60:Placebo) for subjects experiencing ALT > ULN
Time frame: within one year of starting treatment
Odds ratio (Orlistat60:Placebo) for subjects experiencing BIL > ULN
Time frame: within one year of starting treatment
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017; AzTrials last refreshed its copy on 7 Nov 2026.