A 2 part clinical study that will evaluate the safety and effectiveness of LJN452A to treat patients with fatty liver disease for a period of 12 weeks. The first part will be used for LJN452 dose selection for the second part of the study.
- Conditions
- on-alcoholic Steatohepatitis (NASH)MedDRA version: 19.0Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2015-005215-33-ES
- Lead Sponsor
- ovartis Farmacéutica, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 350
Written informed consent must be obtained before any assessment is performed
Male and female patients 18 years or older (at the time of the screening visit)
Presence of NASH as demonstrated by ONE of the following:
- Histologic evidence of NASH based on liver biopsy obtained 2 years or less before randomization with a diagnosis consistent with NASH, fibrosis level F1, F2 or F3, no diagnosis of alternative chronic liver diseases
AND
ALT = 60 IU/L (males) or = 40 IU/L (females)
OR
Phenotypic diagnosis of NASH based on presence of ALL THREE of the following:
o ALT = 60 IU/L (males) or = 40 IU/L (females) AND
o BMI = 27 kg/m2 (in patients with a self-identified race other than Asian) or =23 kg/m2 (in patients with a self-identified Asian race)
AND
o Diagnosis of Type 2 diabetes mellitus by having either:
- HbA1C = 6.5% or
- Drug therapy for Type 2 diabetes mellitus
Liver fat = 10% at screening as determined by the central MRI laboratory
Patients must weigh at least 40 kg (88 lb) and no more than 150 kg (330 lb) to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 138
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 112
Previous exposure to obeticholic acid (OCA)
Patients taking medications prohibited by the protocol
Pregnant or nursing (lactating) women
Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more than 20 g/day in females and more than 30 g/day in males, on average) and/or a score on the AUDIT questionnaire =8
Uncontrolled diabetes defined as HbA1c = 9.5% within 60 days prior to enrollment
Presence of cirrhosis on liver biopsy or clinical diagnosis
Clinical evidence of hepatic decompensation or severe liver impairment
Previous diagnosis of other forms of chronic liver disease
Patients with contraindications to MRI imaging
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method