Clinical trial comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of non-alcoholic fatty liver disease

Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of non-alcoholic fatty liver disease (NAFLD) - Norursodeoxycholic acid vs. Placebo in NAFLD

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004605-38-AT

Enrollment

195

Registered

2014-12-02

Start date

2015-01-14

Completion date

Unknown

Last updated

2016-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic fatty liver disease (NAFLD) MedDRA version: 17.1 Level: LLT Classification code 10029530 Term: Non-alcoholic fatty liver System Organ Class: 100000004871

Interventions

Product Name: Norursodeoxycholic acid Product Code: norUDCA Pharmaceutical Form: Capsule INN or Proposed INN: Norursodeoxycholic acid CAS Number: 99697-24-2 Current Sponsor code: norUDCA Other descri

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Signed informed consent, 2. Male or female patients = 18 and =65 years) yes F.1.3.1 Number of subjects for this age range 45

Exclusion criteria

Exclusion criteria: 4. History or presence of other concomitant liver diseases including: • Positive hepatitis B or C serology (Hbs Ag+, anti-HBc+, anti-HCV; Note: Patients who present with anti-HBc+ only, may be included if they are HBV-DNA negative) • Primary Biliary Cirrhosis (AMA-positive) • Primary Sclerosing Cholangitis •Wilson’s Disease • Haemochromatosis • Autoimmune Hepatitis • a1AT deficiency • Known bile duct obstruction • Drug induced liver disease • Suspected or proven liver cancer 5. Treatment with any of the following drugs potentially associated with NAFLD within the last 3 months prior to baseline including amiodarone, glucocorticosteroids, nifedipin, diltiazem, anabolic steroids, valproic acid, methotrexate, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement and contraceptive use, 11. Presence of cirrhosis > Child Pugh Score A, 12. History or presence of hepatic decompensation (e.g. variceal bleeding, INR > 1.3), hepatic encephalopathy or poorly controlled ascites, 15. AST or ALT > 4 x ULN, 16. Any relevant infectious disease (e.g. active tuberculosis, HIV), 17. Abnormal renal function (Cystatin C > 1,15 x ULN) at screening and/or at baseline visit, 20. Any active malignant disease, or history/treatment thereof in the last five years, 21. Known intolerance/hypersensitivity to study drug, or drugs of similar chemical structure or pharmacological profile, 23. Existing or intended pregnancy or breast-feeding,

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of two doses of norursodeoxycholic acid (norUDCA) vs. placebo for the treatment of NAFLD with or without diabetes mellitus type 2 ;Secondary Objective: To identify efficacious norUDCA dose for the treatment of NAFLD for further evaluation in phase III;Primary end point(s): primary endpoint is the change in serum alanine aminotransferase (ALT);Timepoint(s) of evaluation of this end point: End of treatment (after 12 weeks)	—

Measure

Time frame

Main Objective: To evaluate the efficacy of two doses of norursodeoxycholic acid (norUDCA) vs. placebo for the treatment of NAFLD with or without diabetes mellitus type 2 ;Secondary Objective: To identify efficacious norUDCA dose for the treatment of NAFLD for further evaluation in phase III;Primary end point(s): primary endpoint is the change in serum alanine aminotransferase (ALT);Timepoint(s) of evaluation of this end point: End of treatment (after 12 weeks)

—

Secondary

Measure	Time frame
Secondary end point(s): s-AST, ALT, GGT at each study visit ALT/AST ratio at each study visit;Timepoint(s) of evaluation of this end point: End of treatment (after 12 weeks), some endpoints additionally at each visit	—

Countries

Austria, Germany

Contacts

Public ContactDept. of Clin. Res. & Development

Dr. Falk Pharma GmbH

zentrale@drfalkpharma.de004976115140

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026