Comparing norursodeoxycholic acid to placebo for treating NASH
Double-blind, Randomised, Placebo-controlled, Phase IIb Trial on the Efficacy and Safety of Norursodeoxycholic Acid Tablets in Patients With Non-alcoholic Steatohepatitis (NASH)
PHASE2 · Dr. Falk Pharma GmbH · NCT05083390
This study is testing if a new medication called norursodeoxycholic acid can help people with nonalcoholic steatohepatitis (NASH) improve their liver health compared to a placebo.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 363 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Sponsor | Dr. Falk Pharma GmbH (industry) |
| Locations | 1 site (Vienna) |
| Trial ID | NCT05083390 on ClinicalTrials.gov |
What this trial studies
This phase IIb trial is a double-blind, randomized, multi-center study that aims to evaluate the efficacy of norursodeoxycholic acid (norUDCA) in treating nonalcoholic steatohepatitis (NASH). Participants will be assigned to one of three groups receiving either 1500 mg/d or 1000 mg/d of norUDCA or a placebo. The study will assess the treatment's impact on liver histology and fibrosis in patients diagnosed with NASH. The trial is designed to provide insights into the potential benefits of norUDCA in managing this liver condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed NASH and liver fibrosis.
Not a fit: Patients with liver cirrhosis, significant concomitant liver diseases, or uncontrolled diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve liver health and outcomes for patients with NASH.
How similar studies have performed: Previous studies have shown promise in using norursodeoxycholic acid for liver conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vienna
- Medical University of Vienna, Department of Internal Medicine III — Vienna, Austria (RECRUITING)
Study contacts
- Principal investigator: Michael Trauner, MD — Medical University of Vienna, Department of Internal Medicine III
- Study coordinator: Michael Stiess, PhD
- Email: zentrale@drfalkpharma.de
- Phone: ++49-761-1514
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nonalcoholic Steatohepatitis