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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2016
• Main ID: NCT01277094
• Date of registration: 13/01/2011
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of RO5093151 in Patients With Non-Alcoholic Fatty Liver Disease
• Scientific 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.
• Date of first enrolment: April 2011
• Target sample size: 82
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01277094
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Austria, Germany

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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



Age minimum: 35 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD

Intervention(s)

Drug: RO5093151

Drug: Placebo

Primary Outcome(s)

Change of liver fat content measured by magnetic resonance spectroscopy (MRS) [Time Frame: Week 12]

Secondary Outcome(s)

Change in endogenous glucose production assessed by hyperinsulinemic euglycemic clamp [Time Frame: Week 12]

Change in insulin resistance assessed by hyperinsulinemic euglycemic clamp [Time Frame: Week 12]

Pharmacokinetic measures (max and min concentration, clearance, half-life, etc) [Time Frame: Week 12]

Safety (incidence and nature of adverse events) [Time Frame: Week 12]

Secondary ID(s)

BP25414

Source(s) of Monetary Support

Please refer to primary and secondary sponsors