Norursodeoxycholic Acid vs. Placebo in NASH

Launched by DR. FALK PHARMA GMBH · Oct 6, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness of a medication called norursodeoxycholic acid (norUDCA) in treating a liver condition known as Nonalcoholic Steatohepatitis (NASH). NASH is a type of liver disease that can cause inflammation and damage to the liver, and this study aims to compare two different doses of norUDCA (1500 mg and 1000 mg) to a placebo (a dummy pill with no active medication) to see if the treatment can help improve liver health.

To participate in the trial, you need to be between 18 and 75 years old and have been diagnosed with NASH and liver fibrosis, which is a type of scarring in the liver. It’s important that you are willing to provide consent to join the study. Participants will be randomly assigned to receive either the medication or the placebo and will be monitored throughout the trial. This study is currently recruiting participants, and it is essential to note that certain health conditions, such as cirrhosis (advanced liver scarring) and uncontrolled diabetes, may exclude you from participating. If you join, you'll help researchers understand if this treatment can make a difference for people with NASH.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Must be willing to participate in the study and provide written informed consent
• • Male or female patients ≥ 18 and \< 75 years
• • Centrally assessed histological evidence of NASH and liver fibrosis
• • Women of childbearing potential agree to use a highly effective method of birth control during the entire duration of the trial and for 4 weeks following the last dose of trial treatment
• Exclusion Criteria:
• • Patients taking prohibited medications
• • Presence of liver cirrhosis
• • Type 1 diabetes or uncontrolled Type 2 diabetes
• • History or presence of any other significant concomitant liver diseases
• • History of liver transplantation
• • BMI \>45 kg/m\^2
• • Any known relevant infectious disease (e.g., active tuberculosis, acquired immunodeficiency syndrome \[AIDS\]-defining diseases)
• • Abnormal renal function (glomerular filtration rate estimated from cystatin C \< 30 ml/min) at screening visit
• • Any active malignant disease (except for basal cell carcinoma)
• • Existing or intended pregnancy or breast-feeding