Norursodeoxycholic Acid vs. Placebo in NASH

Nonalcoholic Steatohepatitis Clinical Trial

Official title:

Double-blind, Randomised, Placebo-controlled, Phase IIb Trial on the Efficacy and Safety of Norursodeoxycholic Acid Tablets in Patients With Non-alcoholic Steatohepatitis (NASH)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05083390
• Other study ID #: NUT-3/NAS
• Status: Recruiting
• Phase: Phase 2
• Start date: July 8, 2019
• Est. completion date: April 2025

Study information

• Verified date: February 2024
• Source: Dr. Falk Pharma GmbH
• Contact: Michael Stiess, PhD
• Phone: ++49-761-1514
• Email: zentrale[@]drfalkpharma.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a double-blind, randomised, multi-centre, placebo-controlled, comparative, phase IIb trial. The trial will be conducted with three treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with either 1500 mg/d or 1000 mg/d norUDCA tablets vs. placebo tablets for the treatment of NASH.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 363
• Est. completion date: April 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis

Intervention

Drug:
• norUrsodeoxycholic acid
500 mg norUrsodeoxycholic acid or placebo film-coated tablets; 3 tablets/day

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of Internal Medicine III	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with resolution of NASH, assessed by centrally scored liver histology, and no worsening of fibrosis AND/OR improvement of fibrosis, and no worsening of NAS		72 weeks