Fatty LiverPhase 4NCT00160407
Orlistat (Xenical) in the Treatment of Overweight Patients With Nonalcoholic Steatohepatitis (NASH)
A Phase 4 study testing Orlistat (Xenical) and 1400 kcal diet (30% fat) in people with Fatty Liver and Hepatitis, run by St. Louis University at 2 sites in United States.
Trial summary
The purpose of this study is to determine if orlistat (Xenical) therapy in overweight patients with NASH leads to enhanced weight loss over time, with subsequent improvement in the underlying necroinflammatory and fibrotic changes that are typical of NASH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatty Liver, Hepatitis
- What is being tested?
- Orlistat (Xenical) and 1400 kcal diet (30% fat)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2003to Dec 2006
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver biopsy obtained no more than 24 months before randomization with a pathology report confirming that the histological diagnosis is consistent with NASH
- Compensated liver disease with the following laboratory parameters at the entry visit:
- Hemoglobin values of greater than or equal to 12 gm/dl for females or 13 gm/dl for males
- WBC count > 3,000/mm3
- Neutrophil count > 1,500/mm3
- Platelets > 70,000/mm3
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- Albumin >3.0 g/dl
- Serum creatinine <1.4mg/dl
- Ability to give informed consent
- Alanine aminotransferase (ALT) greater than or equal to 40 U/L
- BMI > or equal to 27 kg/m2
- Patients who receive orlistat must agree to participate in Xenicare, a free dietary counseling program provided by Roche (sponsor)
Who cannot join
- Any cause for chronic liver disease other than NASH
- Evidence of decompensated liver disease such as a history of or presence of ascites, bleeding varices, or spontaneous encephalopathy
- History of alcohol consumption of greater than 20 grams per day in the past 2 years
- Prior surgical procedures to include gastroplasty, jejunoileal or jejunocolic bypass
- TPN within the past 6 months
- History of prior organ transplantation
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- Concurrent enrollment in other experimental treatment protocols
- Use of ursodeoxycholic acid, rosiglitazone, pioglitazone, or metformin within the 6-month period before enrollment
- Women who are pregnant or breast-feeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brooke Army Medical Center
San Antonio, Texas, 78234
Saint Louis University
St Louis, Missouri, 63110
About this study
The purpose of this study is to determine if orlistat (Xenical) therapy in overweight patients with NASH leads to enhanced weight loss over time, with subsequent improvement in the underlying necroinflammatory and fibrotic changes that are typical of NASH.
Read the detailed description
Previous studies have suggested that steady weight loss over time will result in improvement in aminotransferases, and more importantly, underlying histopathology in patients with NASH. A total of 50 biopsy-proven NASH patients will be enrolled in a prospective, randomized fashion. Twenty-five patients have been enrolled at the primary study site at Saint Louis University. Recruitment of the next 25 patients is taking place at a study subsite at Brooke Army Medical Center in San Antonio, Texas.
This will be an open-label study comparing an established weight loss program (1400-calorie diet with 30% fat) plus daily vitamin E (800 IU) and a daily multivitamin to the same weight loss program, daily vitamin E (800 IU) and multivitamin, plus orlistat (120 mg), three times daily for 36 weeks.
Data to be collected from prospective patients includes demographic information, such as age, sex, past medical history, medications, height and weight. Biochemical data to be collected from prospective patients includes liver enzymes, measures of insulin resistance to include, insulin levels, lipid panel, hemoglobin A1C, free fatty acids, complete blood count, coagulation studies, and vitamin E levels. Blood will also be collected and stored for markers of inflammation and fibrosis, such as C reactive protein and TNF-alpha. A liver biopsy will be obtained at the completion of the study for both histopathologic analysis and RNA analysis.
- Conditions
- Fatty Liver, Hepatitis
- Being tested
- Orlistat (Xenical), 1400 kcal diet (30% fat)
- Keywords
- nonalcoholic steatohepatitis, enzyme inhibitors, lipase, obesity, insulin resistance
- Medical subject headings
- Fatty Liver, Hepatitis, Non-alcoholic Fatty Liver Disease, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orlistat (Xenical)Drug
1400 kcal diet (30% fat)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is weight loss leading to improvement in the global necroinflammatory and fibrosis scores on liver biopsies. A change of one point in the necroinflammatory grade or fibrosis stage will be considered statistically significant.
Secondary outcomes (1)
BMI,ALT,Serum free fatty acids,HOMA-IR (fasting insulin x fasting glucose/22.4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startOct 2003
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Brent A Tetri, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160407
- Sponsor's protocol ID
- 12458
- Other IDs
- XEN185
- Status last verified
- Nov 2007
- First submitted
- 8 Sep 2005
- Last updated
- 20 Nov 2007
- Results posted
- No
Publications
Harrison SA, Fecht W, Brunt EM, Neuschwander-Tetri BA. Orlistat for overweight subjects with nonalcoholic steatohepatitis: A randomized, prospective trial. Hepatology. 2009 Jan;49(1):80-6. doi: 10.1002/hep.22575.
PubMed 19053049
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orlistat (Xenical) in the Treatment of Overweight Patients With Nonalcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT00160407
- Acronym / sponsor ID
- 12458
- Conditions
- Fatty Liver, Hepatitis
- Keywords
- nonalcoholic steatohepatitis, enzyme inhibitors, lipase, obesity, insulin resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Oct 2003
- Study completion
- Dec 2006 (actual)
- First posted
- 12 Sep 2005 (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.
The purpose of this study is to determine if orlistat (Xenical) therapy in overweight patients with NASH leads to enhanced weight loss over time, with subsequent improvement in the underlying necroinflammatory and fibrotic changes that are typical of NASH.
Detailed description
Previous studies have suggested that steady weight loss over time will result in improvement in aminotransferases, and more importantly, underlying histopathology in patients with NASH. A total of 50 biopsy-proven NASH patients will be enrolled in a prospective, randomized fashion. Twenty-five patients have been enrolled at the primary study site at Saint Louis University. Recruitment of the next 25 patients is taking place at a study subsite at Brooke Army Medical Center in San Antonio, Texas.
This will be an open-label study comparing an established weight loss program (1400-calorie diet with 30% fat) plus daily vitamin E (800 IU) and a daily multivitamin to the same weight loss program, daily vitamin E (800 IU) and multivitamin, plus orlistat (120 mg), three times daily for 36 weeks.
Data to be collected from prospective patients includes demographic information, such as age, sex, past medical history, medications, height and weight. Biochemical data to be collected from prospective patients includes liver enzymes, measures of insulin resistance to include, insulin levels, lipid panel, hemoglobin A1C, free fatty acids, complete blood count, coagulation studies, and vitamin E levels. Blood will also be collected and stored for markers of inflammation and fibrosis, such as C reactive protein and TNF-alpha. A liver biopsy will be obtained at the completion of the study for both histopathologic analysis and RNA analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Liver biopsy obtained no more than 24 months before randomization with a pathology report confirming that the histological diagnosis is consistent with NASH
- Compensated liver disease with the following laboratory parameters at the entry visit:
- Serum creatinine <1.4mg/dl
- Ability to give informed consent
- Alanine aminotransferase (ALT) greater than or equal to 40 U/L
Key exclusion criteria (9 listed)
- Any cause for chronic liver disease other than NASH
- Evidence of decompensated liver disease such as a history of or presence of ascites, bleeding varices, or spontaneous encephalopathy
- History of alcohol consumption of greater than 20 grams per day in the past 2 years
- Prior surgical procedures to include gastroplasty, jejunoileal or jejunocolic bypass
- TPN within the past 6 months
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 (Xenical) | Drug | – |
| 1400 kcal diet (30% fat) | Behavioural | – |
Primary outcome
The primary endpoint is weight loss leading to improvement in the global necroinflammatory and fibrosis scores on liver biopsies. A change of one point in the necroinflammatory grade or fibrosis stage will be considered statistically significant.
1 secondary outcome
BMI,ALT,Serum free fatty acids,HOMA-IR (fasting insulin x fasting glucose/22.4)
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 20 Nov 2007.
- Derived from this study: PubMed 19053049Harrison SA, Fecht W, Brunt EM, Neuschwander-Tetri BA. Orlistat for overweight subjects with nonalcoholic steatohepatitis: A randomized, prospective trial. Hepatology. 2009 Jan;49(1):80-6. doi: 10.1002/hep.22575.
- American Liver Foundation description of NASHLink provided by the sponsor.
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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.
Brent A Tetri, MD principal investigator
St. Louis University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Orlistat (Xenical) and 1400 kcal diet (30% fat) in people with Fatty Liver and Hepatitis, run by St. Louis University at 2 sites in United States.
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 12 inclusion and 9 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 20 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary endpoint is weight loss leading to improvement in the global necroinflammatory and fibrosis scores on liver biopsies. A change of one point in the necroinflammatory grade or fibrosis stage will be considered statistically significant.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00160407, which also lists 1 linked publication.
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 20 Nov 2007.