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) - CLJN452A2202

ovartis0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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:
•o 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 (i.e. fibrosis in the absence of established cirrhosis), no diagnosis of alternative chronic liver diseases AND
•o ALT * 43 IU/L (males) or * 28 IU/L (females)
•o Phenotypic diagnosis of NASH based on presence of ALL THREE of the following:
•- ALT * 60 IU/L (males) or * 40 IU/L (females) AND
•- 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
•- 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

•- 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