search
Back to results

Norursodeoxycholic Acid vs. Placebo in NASH

Primary Purpose

Nonalcoholic Steatohepatitis

Status
Recruiting
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
norUrsodeoxycholic acid
Sponsored by
Dr. Falk Pharma GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Steatohepatitis

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Vienna, Department of Internal Medicine IIIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

norUrsodeoxycholic acid 1500 mg/day

norUrsodeoxycholic acid 1000 mg/day

Placebo to norUrsodeoxycholic acid

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 6, 2021
Last Updated
February 15, 2023
Sponsor
Dr. Falk Pharma GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT05083390
Brief Title
Norursodeoxycholic Acid vs. Placebo in NASH
Official Title
Double-blind, Randomised, Placebo-controlled, Phase IIb Trial on the Efficacy and Safety of Norursodeoxycholic Acid Tablets in Patients With Non-alcoholic Steatohepatitis (NASH)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2019 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Falk Pharma GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
363 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
norUrsodeoxycholic acid 1500 mg/day
Arm Type
Experimental
Arm Description
3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1500 mg
Arm Title
norUrsodeoxycholic acid 1000 mg/day
Arm Type
Experimental
Arm Description
3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1000 mg
Arm Title
Placebo to norUrsodeoxycholic acid
Arm Type
Placebo Comparator
Arm Description
3 film-coated tablets once daily for 72 weeks containing placebo to norUrsodeoxycholic acid
Intervention Type
Drug
Intervention Name(s)
norUrsodeoxycholic acid
Other Intervention Name(s)
norucholic acid, norUDCA, NCA
Intervention Description
500 mg norUrsodeoxycholic acid or placebo film-coated tablets; 3 tablets/day
Primary Outcome Measure Information:
Title
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
Time Frame
72 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Stiess, PhD
Phone
++49-761-1514
Ext
0
Email
zentrale@drfalkpharma.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Trauner, MD
Organizational Affiliation
Medical University of Vienna, Department of Internal Medicine III
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna, Department of Internal Medicine III
City
Vienna
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Trauner, MD
Phone
0043 (0)1 40400
Ext
47440
Email
michael.trauner@meduniwien.ac.at

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It is not yet decided which data will be made available. Neither a time frame can be indicated yet.

Learn more about this trial

Norursodeoxycholic Acid vs. Placebo in NASH

We'll reach out to this number within 24 hrs