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A Study of RO5093151 in Patients With Non-Alcoholic Fatty Liver Disease

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01277094
Collaborator
(none)
82
Enrollment
4
Locations
2
Arms
11
Duration (Months)
20.5
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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.
Study Start Date :
Apr 1, 2011
Actual Primary Completion Date :
Mar 1, 2012
Actual Study Completion Date :
Mar 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: RO5093151
Oral daily doses for 12 weeks
Placebo Comparator: 2

Drug: Placebo
Oral daily doses for 12 weeks

Outcome Measures

Primary Outcome Measures

  1. Change of liver fat content measured by magnetic resonance spectroscopy (MRS) [Week 12]

Secondary Outcome Measures

  1. Change in insulin resistance assessed by hyperinsulinemic euglycemic clamp [Week 12]

  2. Change in endogenous glucose production assessed by hyperinsulinemic euglycemic clamp [Week 12]

  3. Pharmacokinetic measures (max and min concentration, clearance, half-life, etc) [Week 12]

  4. Safety (incidence and nature of adverse events) [Week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wien Austria 1090
2 Dusseldorf Germany 40225
3 Nuthetal Germany 14558
4 Tübingen Germany 72076

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01277094
Other Study ID Numbers:
  • BP25414
First Posted:
Jan 14, 2011
Last Update Posted:
Nov 2, 2016
Last Verified:
Nov 1, 2016
Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Nov 2, 2016