A randomized, double-blind, placebo controlled, 2- part, adaptive design, multicenter 12-week study to assess safety, tolerability and efficacy of LJN452 in patients with non-alcoholic steatohepatitis (NASH) FLIGHT-FXR

ovartis Farmacéutica, S.A.0 个研究点目标入组 350 人开始时间: 2016年8月5日最近更新: 2021年10月8日

研究概览

暂无简介。

•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
•ALT = 60 IU/L (males) or = 40 IU/L (females)
•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)
•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

发起方

ovartis Farmacéutica, S.A.