- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01277094
A Study of RO5093151 in Patients With Non-Alcoholic Fatty Liver Disease
November 1, 2016 updated by: Hoffmann-La Roche
Multi-center, Double-blind, Randomized, Placebo-controlled Study of Selective 11 Beta-HSD1 Inhibition With RO5093151 for 12 Weeks to Investigate Efficacy, Safety and Pharmacokinetics of RO5093151 in Non-alcoholic Fatty Liver Disease and Its Metabolic Consequences.
This multi-center, double-blind, randomized, placebo-controlled study will evaluate the change in liver fat content, pharmacokinetics and safety of RO5093151 in patients with non-alcoholic fatty liver disease.
Patients will be randomized to receive either daily oral doses of RO5093151 or matching placebo.
The anticipated time on study treatment is 12 weeks.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
33 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients, 35-65 years of age
- Hepatic steatosis assessed by magnetic resonance spectroscopy (MRS) with liver fat >5.56% at screening
- Body mass index (BMI) >27 kg/m2 at screening
- Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR) > 2.5 at screening
- Agreement to maintain prior diet and exercise habits during the full course of study
Exclusion Criteria:
- History of diabetes mellitus based on World Health Organization (WHO) criteria
- Known polycystic ovary syndrome
- Other liver disease e.g. chronic viral hepatitis, alcoholic liver disease, hemachromatosis, cirrhosis
- Known autoimmune disease or chronic inflammatory disease
- Myocardial infarction or stroke within 6 months prior to screening
- Patients taking any anti-diabetic and/or weight-lowering medication currently or within the previous 3 months before screening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Oral daily doses for 12 weeks
|
Placebo Comparator: 2
|
Oral daily doses for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of liver fat content measured by magnetic resonance spectroscopy (MRS)
Time Frame: Week 12
|
Week 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in insulin resistance assessed by hyperinsulinemic euglycemic clamp
Time Frame: Week 12
|
Week 12
|
Change in endogenous glucose production assessed by hyperinsulinemic euglycemic clamp
Time Frame: Week 12
|
Week 12
|
Pharmacokinetic measures (max and min concentration, clearance, half-life, etc)
Time Frame: Week 12
|
Week 12
|
Safety (incidence and nature of adverse events)
Time Frame: Week 12
|
Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
January 13, 2011
First Submitted That Met QC Criteria
January 13, 2011
First Posted (Estimate)
January 14, 2011
Study Record Updates
Last Update Posted (Estimate)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BP25414
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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