A study to test whether different doses of BI 456906 are effective in people with a liver disease called non-alcoholic steatohepatitis (NASH) and liver fibrosis

JRCT ID: jRCT2051210037

Registered date:14/06/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-alcoholic steatohepatitis
• Date of first enrollment: 31/07/2021
• Target sample size: 240
• Countries of recruitment: Australia,Japan,Austria,Japan,Belgium,Japan,Canada,Japan,China,Japan,Czech Republic,Japan,Germany,Japan,Spain,Japan,France,Japan,United Kingdom,Japan,Greece,Japan,Hong Kong,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Korea, Republic of,Japan,Malaysia,Japan,Netherlands,Japan,New Zealand,Japan,Poland,Japan,Singapore,Japan,Taiwan,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): Investigational Medical Product: BI 456906 or Placebo

Outcome(s)

• Primary Outcome: The improvement (yes/ no) from baseline in liver histological findings based on liver biopsy after 48 weeks of treatment in patients with NASH (NAS >= 4, fibrosis F1-F3).

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

Male or female patients >18 years and < 80 years of age at time of consent
Diagnosis of NASH and fibrosis stage F1-F3 proven by a biopsy conducted during the screening period or by a historical biopsy conducted within the last 6 months prior to randomization and stable body weight defined as less than 5% self-reported change in body weight between the historical biopsy and randomization, if a historical biopsy is used
Liver fat fraction >8% measured by MRI-PDFF and liver stiffness > 6.0kPa measured by FibroScan at Visit 1
BMI >25 kg/m2 and a body weight >70 kg at Visit 1

Exclude criteria

-Current or history of significant alcohol consumption (defined as intake of > 210 g/ week in males and > 140 g/week in females on average over a consecutive period of more than 3 months) or inability to reliably quantify alcohol consumption based on Investigator judgement within the last 5 years.
-Intake of medications historically associated with liver injury, hepatic steatosis or steatohepatitis within 12 weeks prior to Visit 1. Intake of restricted medications or any medications considered likely to interfere with the safe conduct of the trial.
-History of other forms of chronic liver disease (e.g. viral hepatitis, autoimmune liver disease, primary biliary sclerosis, primary sclerosing cholangitis, Wilson`s disease, hemochromatosis, A1At deficiency, history of liver transplantation).
-Suspicion, diagnosis or history of hepatocellular carcinoma (HCC), or any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix.
-Diagnosis of a serious or unstable disease including hepatic (other than NASH), renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease and other conditions that, in the clinical judgment of the Investigator, are likely to interfere with the analyses of safety and efficacy in this trial. Patients with a history of organ transplantation except for corneal transplantation and patients with an expected life expectancy of less than 2 years are also excluded.

Related Information

• Primary Sponsor: Kenmochi Hiroki
• Secondary ID(s): NCT04771273