Norursodeoxycholic Acid vs. Placebo in NASH

Last updated: February 16, 2024
Sponsor: Dr. Falk Pharma GmbH
Overall Status: Active - Recruiting

Phase

2

Condition

Liver Disease

Treatment

norUrsodeoxycholic acid

Clinical Study ID

NCT05083390
NUT-3/NAS
  • Ages 18-74
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 birthcontrol during the entire duration of the trial and for 4 weeks following the lastdose of trial treatment

Exclusion

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, acquiredimmunodeficiency syndrome [AIDS]-defining diseases)
  • Abnormal renal function (glomerular filtration rate estimated from cystatin C < 30ml/min) at screening visit
  • Any active malignant disease (except for basal cell carcinoma)
  • Existing or intended pregnancy or breast-feeding

Study Design

Total Participants: 363
Treatment Group(s): 1
Primary Treatment: norUrsodeoxycholic acid
Phase: 2
Study Start date:
July 08, 2019
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • Medical University of Vienna, Department of Internal Medicine III

    Vienna,
    Austria

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.