NCT00160407

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2003

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

November 20, 2007

Status Verified

November 1, 2007

First QC Date

September 8, 2005

Last Update Submit

November 19, 2007

Conditions

Fatty LiverHepatitis

Keywords

nonalcoholic steatohepatitisenzyme inhibitorslipaseobesityinsulin resistance

Outcome Measures

Primary Outcomes (1)

  • 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)

Interventions

Orlistat (Xenical)DRUG
1400 kcal diet (30% fat)BEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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)

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Saint Louis University

St Louis, Missouri, 63110, United States

Location

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

Related Publications (1)

  • 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.

    PMID: 19053049DERIVED

MeSH Terms

Conditions

Fatty LiverHepatitisNon-alcoholic Fatty Liver DiseaseObesityInsulin Resistance

Interventions

OrlistatDietCD36 Antigens

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaPlatelet Membrane GlycoproteinsMembrane GlycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesFatty Acid Transport ProteinsMembrane Transport ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsMembrane ProteinsReceptors, Cell SurfaceReceptors, ImmunologicScavenger Receptors, Class BReceptors, ScavengerReceptors, LDLReceptors, Lipoprotein

Study Officials

  • Brent A Tetri, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

October 1, 2003

Study Completion

December 1, 2006

Last Updated

November 20, 2007

Record last verified: 2007-11

Locations

US(2)