Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD Clinical Trial
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.
| Verified date | November 2016 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Austria: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 82 |
| Est. completion date | March 2012 |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 35 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
Austria, Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change of liver fat content measured by magnetic resonance spectroscopy (MRS) | Week 12 | No | |
| Secondary | Change in insulin resistance assessed by hyperinsulinemic euglycemic clamp | Week 12 | No | |
| Secondary | Change in endogenous glucose production assessed by hyperinsulinemic euglycemic clamp | Week 12 | No | |
| Secondary | Pharmacokinetic measures (max and min concentration, clearance, half-life, etc) | Week 12 | No | |
| Secondary | Safety (incidence and nature of adverse events) | Week 12 | No |