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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Oral daily doses for 12 weeks |
| |
| RO5093151 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of liver fat content measured by magnetic resonance spectroscopy (MRS) | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in insulin resistance assessed by hyperinsulinemic euglycemic clamp | Week 12 | |
| Change in endogenous glucose production assessed by hyperinsulinemic euglycemic clamp | Week 12 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna | 1090 | Austria | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24795254 | Derived | 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. |
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Drug |
Oral daily doses for 12 weeks |
|
| Pharmacokinetic measures (max and min concentration, clearance, half-life, etc) |
| Week 12 |
| Safety (incidence and nature of adverse events) | Week 12 |
| Düsseldorf |
| 40225 |
| Germany |
| Nuthetal | 14558 | Germany |
| Tübingen | 72076 | Germany |