Norursodeoxycholic Acid vs. Placebo in NASH

NCT05083390 | Recruiting Phase 2 DMC

• 1 other identifier: NUT-3/NAS
• Study Type: interventional
• Target: 363
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

norUrsodeoxycholic acid 1500 mg/day

EXPERIMENTAL

3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1500 mg

Drug: norUrsodeoxycholic acid

norUrsodeoxycholic acid 1000 mg/day

EXPERIMENTAL

3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1000 mg

Drug: norUrsodeoxycholic acid

Placebo to norUrsodeoxycholic acid

PLACEBO COMPARATOR

3 film-coated tablets once daily for 72 weeks containing placebo to norUrsodeoxycholic acid

Drug: norUrsodeoxycholic acid

Interventions

norUrsodeoxycholic acid DRUG

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

Also known as: norucholic acid, norUDCA, NCA

Placebo to norUrsodeoxycholic acid; norUrsodeoxycholic acid 1000 mg/day; norUrsodeoxycholic acid 1500 mg/day

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Falk Pharma GmbH: lead

Study Sites (1)

Medical University of Vienna, Department of Internal Medicine III

Vienna, Austria

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

24-norursodeoxycholic acid

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Michael Trauner, MD

  Medical University of Vienna, Department of Internal Medicine III

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Stiess, PhD

CONTACT

++49-761-1514; zentrale@drfalkpharma.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 19, 2021
• Study Start: July 8, 2019
• Primary Completion: January 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)