Nonalcoholic SteatohepatitisPhase 2NCT05083390
Norursodeoxycholic Acid vs. Placebo in NASH
A Phase 2 study testing norUrsodeoxycholic acid in people with Nonalcoholic Steatohepatitis, run by Dr. Falk Pharma GmbH at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Nonalcoholic Steatohepatitis
- What is being tested?
- norUrsodeoxycholic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 363 participants
- Where
- 1 siteAustria
- Study dates
- 8 Jul 2019to Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna, Department of Internal Medicine III
Vienna
Michael Trauner, MD, 0043 (0)1 40400 ext. 47440, michael.trauner@meduniwien.ac.at
About this study
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)
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
- Being tested
- norUrsodeoxycholic acid
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
norUrsodeoxycholic acidDrug
Also called norucholic acid, norUDCA, NCA
500 mg norUrsodeoxycholic acid or placebo film-coated tablets; 3 tablets/day
| Study group | Role | What they receive |
|---|---|---|
| norUrsodeoxycholic acid 1500 mg/day | Experimental | 3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1500 mg Receives: 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 Receives: Drug: norUrsodeoxycholic acid |
| Placebo to norUrsodeoxycholic acid | Placebo comparator | 3 film-coated tablets once daily for 72 weeks containing placebo to norUrsodeoxycholic acid Receives: Drug: norUrsodeoxycholic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start8 Jul 2019
- Primary completionJan 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 363 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Falk Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Trauner, MD, Principal investigator, Medical University of Vienna, Department of Internal Medicine III
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083390
- Sponsor's protocol ID
- NUT-3/NAS
- Status last verified
- Feb 2024
- First submitted
- 6 Oct 2021
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not yet decided which data will be made available. Neither a time frame can be indicated yet.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05083390
- Acronym / sponsor ID
- NUT-3/NAS
- Conditions
- Nonalcoholic Steatohepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 363 participants (estimated)
- Lead sponsor
- Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| norUrsodeoxycholic acid 1500 mg/day | Experimental | Drug: norUrsodeoxycholic acid3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1500 mg |
| norUrsodeoxycholic acid 1000 mg/day | Experimental | Drug: norUrsodeoxycholic acid3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1000 mg |
| Placebo to norUrsodeoxycholic acid | Placebo comparator | Drug: norUrsodeoxycholic acid3 film-coated tablets once daily for 72 weeks containing placebo to norUrsodeoxycholic acid |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| norUrsodeoxycholic acidAlso: norucholic acid, norUDCA, NCA500 mg norUrsodeoxycholic acid or placebo film-coated tablets; 3 tablets/day | Drug | Placebo to norUrsodeoxycholic acid, norUrsodeoxycholic acid 1000 mg/day, norUrsodeoxycholic acid 1500 mg/day |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No. It is not yet decided which data will be made available. Neither a time frame can be indicated yet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Trauner, MD principal investigator
Medical University of Vienna, Department of Internal Medicine III
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing norUrsodeoxycholic acid in people with Nonalcoholic Steatohepatitis, run by Dr. Falk Pharma GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Stiess, PhD (++49-761-1514 ext. 0, zentrale@drfalkpharma.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.