Status:
COMPLETED
Study to Assess the Efficacy, Safety and Tolerability of LCQ908 in NAFLD Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Non-alcoholic Fatty Liver Disease (NAFLD)
Eligibility:
All Genders
18-74 years
Phase:
PHASE2
Brief Summary
The purpose of this study was to determine whether LCQ908 effectively lowers liver fat, as assessed by MRI and to assess its safety and tolerability profile in subjects with non-alcoholic fatty liver ...
Eligibility Criteria
Inclusion
- History of liver steatosis during the preceding 24 months
- History of fasting TGs \> 200 mg/dL (confirmed at screening).
- Liver fat ≥ 10% as determined by the central MRI laboratory.
- Subjects on the following medications can be included if these medications are medically necessary, cannot be stopped and the investigator feels their dose will remain stable for the duration of the double-blind treatment period:
- Stable dose of anti-diabetic medications (metformin and/or sulfonylureas) for at least 8 weeks prior to screening.
- Stable doses of beta-blockers and thiazide diuretics for at least 8 weeks prior to screening.
- Stable doses of fibrates, statins, niacin, ezetimibe for at least 8 weeks prior to screening.
- Stable dose of vitamin E in patients taking \>200 IU/day for at least 6 months prior to screening.
Exclusion
- Treatment with omega-3-acid ethyl esters or omega-3-polyunsaturated fatty acid (PUFA)-containing supplements \> 200 mg per day within 8 weeks of screening.
- Treatment with antiretrovirals, tamoxifen, methotrexate, cyclophosphamide, isotretinoin, bile acid binding resins or pharmacologic doses of oral glucocorticoids (≥10 mg of prednisone per day or equivalent) within 8 weeks of screening.
- ALT or AST \> 250 IU/L at the time of screening.
- History/current evidence of heavy alcohol use or alcoholism (\> 21 drinks per week in men and \> 14 drinks per week in women) over a 2-year period prior to screening.
- Presence of chronic liver disease, such as chronic hepatitis B and/or C, alcoholic liver disease, hemochromatosis, Wilson's disease, known cirrhosis.
- Platelet count \<150,000 at screening.
- BMI \>45 Kg/m2.
- Other protocol defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01811472
Start Date
June 1 2013
End Date
September 1 2014
Last Update
February 4 2016
Active Locations (11)
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1
Novartis Investigative Site
Mobile, Alabama, United States, 36608
2
Novartis Investigative Site
San Diego, California, United States, 92114
3
Novartis Investigative Site
Gainesville, Florida, United States, 32610-0277
4
Novartis Investigative Site
Miami, Florida, United States, 33126