A 12-week randomized, patient and investigator blinded, placebo-controlled, parallel group study to investigate the efficacy of LIK066 in obese patients with non-alcoholic steatohepatitis (NASH) - Study to assess efficacy of LIK066 in obese patients with non-alcoholic steatohepatitis (NASH)

ovartis Pharma AG0 个研究点目标入组 107 人开始时间: 2017年10月16日最近更新: 2021年4月5日

研究概览

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•Histologic confirmed NASH based on liver biopsy obtained 2 years or less before randomization with a fibrosis level of F1, F2 or F3 in the absence of a histological diagnosis of alternative chronic liver disease AND ALT greater than or equal to 50 IU/L (males) or greater than or equal to 35 IU/L (females) at screening.
•Phenotypic diagnosis of NASH based on presence of ALL three of the following at screening:
•-ALT greater than or equal to 50IU/L (males) or greater than or equal to 35 IU/L (females) AND
•-BMI greater than or equal to 27 kg/m^2 (in patients with a self-identified race other than Asian) or greater than or equal
•to 23 kg/m^2 (in patients with a self identified Asian race) AND
•-Diagnosis of Type 2 diabetes mellitus by HbA1c: greater than or equal to 6.5 % and less than or equal to 10%.
•Patients must weigh no more than 150 kg (330 lbs) to participate in the study.
•Male and female patients 18 years or older at the time of screening visit.
•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 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•- History or presence of other concomitant liver diseases.
•- History or current diagnosis of ECG abnormalities.
•- Use of GLP-1 agonists, SGLT2 inhibitors, TZDs, FXR agonists and any pharmacologically active weight loss drugs within 6 weeks of screening and until end of study.
•- Patients with contraindications to MRI imaging.
•- Current or history of significant alcohol consumption.
•- Clinical evidence of hepatic decompensation or severe liver impairment.
•- Women of child bearing potential (unless on basic contraception methods).
•- Presence of liver cirrhosis.

发起方