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Norursodeoxycholic Acid vs. Placebo in NASH

NCT05083390 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 363

Last updated 2024-02-20

No results posted yet for this 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.

Conditions

Interventions

DRUG

norUrsodeoxycholic acid

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

Sponsors & Collaborators

  • Dr. Falk Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Michael Trauner, MD · Medical University of Vienna, Department of Internal Medicine III

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-08
Primary Completion
2025-01-31
Completion
2025-04-30

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05083390 on ClinicalTrials.gov