Back to results

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

Primary Purpose

Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Placebo

RO5093151

About this trial

This is an interventional treatment trial for Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Change of liver fat content measured by magnetic resonance spectroscopy (MRS)

Secondary Outcome Measures

Change in insulin resistance assessed by hyperinsulinemic euglycemic clamp

Change in endogenous glucose production assessed by hyperinsulinemic euglycemic clamp

Pharmacokinetic measures (max and min concentration, clearance, half-life, etc)

Safety (incidence and nature of adverse events)

Full Information

NCT ID

NCT01277094

First Posted

January 13, 2011

Last Updated

November 1, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01277094

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral daily doses for 12 weeks

Intervention Type

Drug

Intervention Name(s)

RO5093151

Intervention Description

Oral daily doses for 12 weeks

Primary Outcome Measure Information:

Title

Change of liver fat content measured by magnetic resonance spectroscopy (MRS)

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Change in insulin resistance assessed by hyperinsulinemic euglycemic clamp

Time Frame

Week 12

Title

Change in endogenous glucose production assessed by hyperinsulinemic euglycemic clamp

Time Frame

Week 12

Title

Pharmacokinetic measures (max and min concentration, clearance, half-life, etc)

Time Frame

Week 12

Title

Safety (incidence and nature of adverse events)

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

City

Wien

ZIP/Postal Code

1090

Country

Austria

City

Dusseldorf

ZIP/Postal Code

40225

Country

Germany

City

Nuthetal

ZIP/Postal Code

14558

Country

Germany

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

24795254

Citation

Stefan N, Ramsauer M, Jordan P, Nowotny B, Kantartzis K, Machann J, Hwang JH, Nowotny P, Kahl S, Harreiter J, Hornemann S, Sanyal AJ, Stewart PM, Pfeiffer AF, Kautzky-Willer A, Roden M, Haring HU, Furst-Recktenwald S. Inhibition of 11beta-HSD1 with RO5093151 for non-alcoholic fatty liver disease: a multicentre, randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2014 May;2(5):406-16. doi: 10.1016/S2213-8587(13)70170-0. Epub 2014 Feb 17.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs