NCT01277094

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2011

Geographic Reach
2 countries

4 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

First Submitted

Initial submission to the registry

January 13, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

11 months

First QC Date

January 13, 2011

Last Update Submit

November 1, 2016

Conditions

Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD

Outcome Measures

Primary Outcomes (1)

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

    Week 12

Secondary Outcomes (4)

  • Change in insulin resistance assessed by hyperinsulinemic euglycemic clamp

    Week 12

  • Change in endogenous glucose production assessed by hyperinsulinemic euglycemic clamp

    Week 12

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

    Week 12

  • Safety (incidence and nature of adverse events)

    Week 12

Study Arms (2)

1

EXPERIMENTAL
Drug: RO5093151

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PlaceboDRUG

Oral daily doses for 12 weeks

2
RO5093151DRUG

Oral daily doses for 12 weeks

1

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Vienna, 1090, Austria

Location

Unknown Facility

Düsseldorf, 40225, Germany

Location

Unknown Facility

Nuthetal, 14558, Germany

Location

Unknown Facility

Tübingen, 72076, Germany

Location

Related Publications (1)

  • 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.

    PMID: 24795254DERIVED

MeSH Terms

Conditions

Fatty LiverNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2011

First Posted

January 14, 2011

Study Start

April 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

AU(1)DE(3)