Clinical trial NCT01277094: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-01-14
Enrollment: 82
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change of liver fat content measured by magnetic resonance spectroscopy (MRS)
timeFrame: Week 12
Secondary outcomes:
measure: Change in insulin resistance assessed by hyperinsulinemic euglycemic clamp
timeFrame: Week 12
measure: Change in endogenous glucose production assessed by hyperinsulinemic euglycemic clamp
timeFrame: Week 12
measure: Pharmacokinetic measures (max and min concentration, clearance, half-life, etc)
timeFrame: Week 12
measure: Safety (incidence and nature of adverse events)
timeFrame: Week 12
Other outcomes:
Locations:
city: Wien
country: Austria
city: Dusseldorf
country: Germany
city: Nuthetal
country: Germany
city: Tübingen
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
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.