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    Clinical Trial Results:
    Double-blind, randomised, placebo-controlled, phase IIb trial on the efficacy and safety of norursodeoxycholic acid tablets in patients with non-alcoholic steatohepatitis (NASH)

    Summary
    EudraCT number
    		 2018-003443-31
    Trial protocol
    		 CZ   GB   AT   HU   PL   ES   DE   LV   BE   GR   NL   FR   DK   PT   IT  
    Global end of trial date
    11 Mar 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 May 2026
    First version publication date
    06 May 2026
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    NUT-3/NAS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dr. Falk Pharma GmbH
    Sponsor organisation address
    Leinenweberstr. 5, Freiburg, Germany, 79108
    Public contact
    Department of Clinical Research, Dr. Falk Pharma GmbH, +49 76115140, zentrale@drfalkpharma.de
    Scientific contact
    Department of Clinical Research, Dr. Falk Pharma GmbH, +49 76115140, zentrale@drfalkpharma.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Jun 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Mar 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of norursodeoxycholic acid (norUDCA) 1500 mg vs. norUDCA 1000 mg vs. placebo for the treatment of NASH
    Protection of trial subjects
    Prior to recruitment of patients, all relevant documents of the clinical study were submitted and approved by the Independent Ethics Committees (IECs) responsible for the participating investigators. Written consent documents embodied the elements of informed consent as described in the Declaration of Helsinki, the ICH Guidelines for Good Clinical Practice (GCP) and were in accordance with all applicable laws and regulations. The informed consent form and patient information sheet described the planned and permitted uses, transfers and disclosures of the patient's personal data and personal health information for purposes of conducting the study. The informed consent form and the patient information sheet further explained the nature of the study, its objectives and potential risks and benefits as well as the date informed consent was given. Before being enrolled in the clinical trial, every patient was informed that participation in this trial was voluntary and that he/she could withdraw from the study at any time without giving a reason and without having to fear any loss in his/her medical care. The patient’s consent was obtained in writing before the start of the study. By signing the informed consent, the patient declared that he/she was participating voluntarily and intended to follow the study protocol instructions and the instructions of the investigator and to answer the questions asked during the course of the trial. The choosen dose range, schedule, and treatment duration was proved to be clinically safe and justifiable. Furthermore, an independent Data and Safety Monitoring Board (DSMB) has been established to closely monitor the patients’ safety parameters during the trial
    Background therapy
    		 The treatment of accompanying illnesses not subject to the exclusion criteria in the protocol was permissible if this was not expected to have any effect on the outcome measures used in the trial, the safety of the patient, or to interfere with the trial medication. Based on the protocol existing, permitted concomitant medication are not to be changed during the treatment phase of the trial. A Modification of the intake regimen (dosage change, switch between drugs etc.) following ongoing drugs from 6 months prior to screening until EOT/withdrawal visit: - Antidiabetic drugs (any; including insulin) - Statins (any)
    Evidence for comparator
    		 As no effective therapy is authorised for the treatment of NASH, a placebo arm was included as control for the assessment of efficacy and safety of the trial drug
    Actual start date of recruitment
    01 Apr 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 34
    Country: Number of subjects enrolled
    United Kingdom: 25
    Country: Number of subjects enrolled
    Belgium: 18
    Country: Number of subjects enrolled
    Austria: 17
    Country: Number of subjects enrolled
    Czechia: 15
    Country: Number of subjects enrolled
    Poland: 45
    Country: Number of subjects enrolled
    Israel: 14
    Country: Number of subjects enrolled
    Spain: 11
    Country: Number of subjects enrolled
    Türkiye: 9
    Country: Number of subjects enrolled
    Ireland: 6
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Hungary: 4
    Country: Number of subjects enrolled
    Georgia: 3
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Switzerland: 2
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Portugal: 2
    Country: Number of subjects enrolled
    Denmark: 1
    Worldwide total number of subjects
    216
    EEA total number of subjects
    163
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    168
    From 65 to 84 years
    48
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In total 216 patients were enrolled in the study in Austria, Belgium, Czech Republic, Denmark, France, Georgia, Germany, Greece, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Switzerland, Turkey and United Kingdom.

    Pre-assignment
    Screening details
    		 In total 912 patients were screened for enrolment of the trial, 692 patients with screening failures, 220 were randomized into the trial groups. 216 patients were treated and included in the full analysis set.

    Period 1
    Period 1 title
    Treatment Phase (overall trial) (overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The trial was conducted with 3 treatment groups in the form of a parallel group comparison. Participants were assigned to one of the 3 treatment groups via a central randomisation procedure using a 1:1:1 balance. To guarantee the double-blinding, the trial was conducted using placebo tablets identical in appearance, shape and taste to active substance. An independent DSMB was establisehd to closely monitor the patients safety parameters.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 1500 mg norUDCA
    Arm description
    		 Treatment with 1500mg norUDCA once daily (OD) - 3 norUDCA tablets a 500mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    1500 mg norUDCA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3 norUDCA tablets a 500mg

    Arm title
    		 1000 mg norUDCA
    Arm description
    		 Treatment with 1000 mg norUDCA, once daily (OD), 2 norUDCA tablets a 500 mg, 1 placebo tablet
    Arm type
    		 Experimental

    Investigational medicinal product name
    1000 mg norUDCA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 norUDCA tablets a 500 mg and 1 placebo tablet once daily (OD)

    Arm title
    		 Placebo
    Arm description
    		 3 placebo tablets once daily (OD)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3 placebo tablets once daily

    Number of subjects in period 1
    		1500 mg norUDCA 1000 mg norUDCA Placebo
    Started
    83
    70
    63
    Completed
    77
    66
    54
    Not completed
    6
    4
    9
         other reasons
    -
    -
    2
         Adverse event, non-fatal
    5
    2
    1
         changes diabetes treatment
    1
    -
    -
         Lack of patients cooperaiton
    -
    1
    1
         Patients wish
    -
    1
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    1500 mg norUDCA
    Reporting group description
    		 Treatment with 1500mg norUDCA once daily (OD) - 3 norUDCA tablets a 500mg

    Reporting group title
    1000 mg norUDCA
    Reporting group description
    		 Treatment with 1000 mg norUDCA, once daily (OD), 2 norUDCA tablets a 500 mg, 1 placebo tablet

    Reporting group title
    Placebo
    Reporting group description
    		 3 placebo tablets once daily (OD)

    Reporting group values
    		 1500 mg norUDCA 1000 mg norUDCA Placebo Total
    Number of subjects
    		 83 70 63 216
    Age categorical
    Age Group 1 ≤ 65 years
    Units: Subjects
        Adults (18-64 years)
    		 62 59 47 168
        From 65-84 years
    		 21 11 16 48
    Gender categorical
    subgroup analysis for gender (Male/ Female)
    Units: Subjects
        Female
    		 45 37 31 113
        Male
    		 38 33 32 103

    End points

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    End points reporting groups
    Reporting group title
    1500 mg norUDCA
    Reporting group description
    		 Treatment with 1500mg norUDCA once daily (OD) - 3 norUDCA tablets a 500mg

    Reporting group title
    1000 mg norUDCA
    Reporting group description
    		 Treatment with 1000 mg norUDCA, once daily (OD), 2 norUDCA tablets a 500 mg, 1 placebo tablet

    Reporting group title
    Placebo
    Reporting group description
    		 3 placebo tablets once daily (OD)

    Primary: Resolution of NASH and/or improvement of fibrosis

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    End point title
    		 Resolution of NASH and/or improvement of fibrosis
    End point description
    Resolution of NASH, assessed by centrally scored liver histology with NAS component ballooning = 0 and improvement of NAS component inflammation to 0 or 1, and no worsening of fibrosis, defined as no increase in NASH CRN fibrosis stage, from baseline to EOT/withdrawal visit AND/OR Improvement of fibrosis, defined as decrease in NASH CRN fibrosis stage by at least 1 stage, and no worsening of NASH, defined as neither worsening in NAS component ballooning nor worsening in NAS component inflammation, from baseline to EOT/withdrawal visit [binary: yes, no]
    End point type
    Primary
    End point timeframe
    Baseline to V9/EOT
    End point values
    		 1500 mg norUDCA 1000 mg norUDCA Placebo
    Number of subjects analysed
    83
    70
    63
    Units: binary
        Yes
    28
    14
    19
        No
    55
    56
    44
    Statistical analysis title
    		 Primary efficacy variable 1500 FAS
    Statistical analysis description
    The Primary efficacy variable (PEV) was the resolution of NASH, assessed by centrally scored liver histology with NAS component ballooning = 0 and improvement of NAS component inflammation to 0 or 1, and no worsening of fibrosis, defined as no increase in NASH CRN fibrosis stage, from baseline to EOT/withdrawal visit
    Comparison groups
    1500 mg norUDCA v Placebo
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.2969 [2]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.213
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.597
         upper limit
    		 2.464
    Notes
    [1] - The variable was tested according to the following a priori hierarchical ordering. 1. norUDCA 1500 vs. placebo 2. norUDCA 1000 vs. placebo
    [2] - Significance testing was performed in the above defined order. If the first test did not reach statistical significance (alpha = 0.025 one-sided), the second test was only performed in an exploratory manner
    Statistical analysis title
    		 Primary efficacy variable 1000 FAS
    Statistical analysis description
    The Primary efficacy variable (PEV) was the resolution of NASH, assessed by centrally scored liver histology with NAS component ballooning = 0 and improvement of NAS component inflammation to 0 or 1, and no worsening of fibrosis, defined as no increase in NASH CRN fibrosis stage, from baseline to EOT/withdrawal visit
    Comparison groups
    1000 mg norUDCA v Placebo
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.9165 [4]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.256
         upper limit
    		 1.266
    Notes
    [3] - The variable was tested according to the following a priori hierarchical ordering. 1. norUDCA 1500 vs. placebo 2. norUDCA 1000 vs. placebo
    [4] - Significance testing was performed in the above defined order. If the first test did not reach statistical significance (alpha = 0.025 one-sided), the second test was only performed in an exploratory manner

    Secondary: Change in NAS

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    End point title
    		 Change in NAS
    End point description
    NAS Score at V9/EOT minus NAS Score at V0
    End point type
    Secondary
    End point timeframe
    From Baseline to EOT/ Withdrawal visit
    End point values
    		 1500 mg norUDCA 1000 mg norUDCA Placebo
    Number of subjects analysed
    83
    70
    63
    Units: points
        arithmetic mean (standard deviation)
    -1.7 ( 1.58 )
    -1.1 ( 1.45 )
    -0.9 ( 1.71 )
    Statistical analysis title
    		 ANCOVA NAS Score 1500 (FAS)
    Statistical analysis description
    analysis of covariance (ANCOVA) models with baseline value as covariate and the class variables treatment, country and T2DM
    Comparison groups
    1500 mg norUDCA v Placebo
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0046
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.229
         upper limit
    		 -0.224
    Statistical analysis title
    		 ANCOVA NAS Score 1000 (FAS)
    Statistical analysis description
    analysis of covariance (ANCOVA) models with baseline value as covariate and the class variables treatment, country and T2DM
    Comparison groups
    1000 mg norUDCA v Placebo
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4051
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.742
         upper limit
    		 0.3

    Secondary: Normalization of ALT

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    End point title
    		 Normalization of ALT
    End point description
    ALT ≤ 0.8 ULN at EOT/withdrawal visit
    End point type
    Secondary
    End point timeframe
    at EOT / withdrawal visit
    End point values
    		 1500 mg norUDCA 1000 mg norUDCA Placebo
    Number of subjects analysed
    69
    62
    57
    Units: binary
    20
    8
    6
    Statistical analysis title
    		 Secondary Efficacy Variables, 1500 (FAS)
    Statistical analysis description
    Normalization of ALT
    Comparison groups
    1500 mg norUDCA v Placebo
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0134
    Method
    		 ANCOVA
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.512
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.298
         upper limit
    		 9.506
    Statistical analysis title
    		 Secondary Efficacy Variables, 1000 (FAS)
    Statistical analysis description
    Normalization of ALT
    Comparison groups
    1000 mg norUDCA v Placebo
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6926
    Method
    		 ANCOVA
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.255
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.407
         upper limit
    		 3.87

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The period of observation for AEs comprised the time the patient gave informed consent until 4 weeks after EOT/withdrawal visit last.
    Adverse event reporting additional description
    treatment-emergent adverse events
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    norUDCA 1500
    Reporting group description
    		 norUDCA 1500 group Treatment emergent Adverse Events - occurring in at least 5% of the participants

    Reporting group title
    norUDCA 1000
    Reporting group description
    		 Treatment emergent adverse events group norUDCA1000

    Reporting group title
    Placebo Group
    Reporting group description
    		 Placeob group with number of participants with at least one AE/TEAE

    Serious adverse events
    		 norUDCA 1500 norUDCA 1000 Placebo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 83 (15.66%)
    11 / 70 (15.71%)
    6 / 63 (9.52%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 70 (1.43%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 70 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuroendocrine tumour of the lung
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 70 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 70 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Breast tumour excision
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 70 (1.43%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm surgery
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 70 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Shoulder operation
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 70 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal operation
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 70 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia repair
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 70 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureteral stent removal
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 70 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 70 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 70 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 70 (1.43%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 70 (1.43%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Unevaluable device issue
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 70 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Occult blood
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 70 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 70 (1.43%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 70 (1.43%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 70 (1.43%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 70 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Deafness neurosensory
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 70 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 70 (1.43%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 70 (1.43%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 70 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 70 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 70 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 70 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 70 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 70 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureteric stenosis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 70 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 70 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 70 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal instability
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 70 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 70 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 70 (1.43%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pilonidal cyst congenital
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 70 (1.43%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 70 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 norUDCA 1500 norUDCA 1000 Placebo Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    74 / 83 (89.16%)
    64 / 70 (91.43%)
    55 / 63 (87.30%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 83 (6.02%)
    3 / 70 (4.29%)
    5 / 63 (7.94%)
         occurrences all number
    6
    4
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 83 (9.64%)
    5 / 70 (7.14%)
    6 / 63 (9.52%)
         occurrences all number
    10
    5
    6
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 83 (1.20%)
    4 / 70 (5.71%)
    0 / 63 (0.00%)
         occurrences all number
    1
    4
    0
    Abdominal pain upper
         subjects affected / exposed
    5 / 83 (6.02%)
    4 / 70 (5.71%)
    6 / 63 (9.52%)
         occurrences all number
    5
    4
    6
    Constipation
         subjects affected / exposed
    5 / 83 (6.02%)
    5 / 70 (7.14%)
    1 / 63 (1.59%)
         occurrences all number
    6
    7
    1
    Diarrhoea
         subjects affected / exposed
    6 / 83 (7.23%)
    4 / 70 (5.71%)
    6 / 63 (9.52%)
         occurrences all number
    8
    4
    8
    Dry mouth
         subjects affected / exposed
    5 / 83 (6.02%)
    2 / 70 (2.86%)
    0 / 63 (0.00%)
         occurrences all number
    5
    2
    0
    Dyspepsia
         subjects affected / exposed
    5 / 83 (6.02%)
    2 / 70 (2.86%)
    3 / 63 (4.76%)
         occurrences all number
    5
    2
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 83 (7.23%)
    3 / 70 (4.29%)
    1 / 63 (1.59%)
         occurrences all number
    7
    3
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    5 / 83 (6.02%)
    1 / 70 (1.43%)
    4 / 63 (6.35%)
         occurrences all number
    5
    1
    4
    Rash
         subjects affected / exposed
    5 / 83 (6.02%)
    1 / 70 (1.43%)
    1 / 63 (1.59%)
         occurrences all number
    6
    2
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    8 / 83 (9.64%)
    3 / 70 (4.29%)
    4 / 63 (6.35%)
         occurrences all number
    8
    3
    4
    Back pain
         subjects affected / exposed
    3 / 83 (3.61%)
    2 / 70 (2.86%)
    6 / 63 (9.52%)
         occurrences all number
    3
    2
    6
    Infections and infestations
    COVID-19
         subjects affected / exposed
    11 / 83 (13.25%)
    9 / 70 (12.86%)
    8 / 63 (12.70%)
         occurrences all number
    11
    10
    10
    Influenza
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 70 (0.00%)
    4 / 63 (6.35%)
         occurrences all number
    2
    0
    4
    Nasopharyngitis
         subjects affected / exposed
    6 / 83 (7.23%)
    6 / 70 (8.57%)
    4 / 63 (6.35%)
         occurrences all number
    6
    7
    5
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 83 (6.02%)
    4 / 70 (5.71%)
    1 / 63 (1.59%)
         occurrences all number
    5
    7
    1
    Urinary tract infection
         subjects affected / exposed
    8 / 83 (9.64%)
    6 / 70 (8.57%)
    4 / 63 (6.35%)
         occurrences all number
    12
    8
    7
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    5 / 83 (6.02%)
    4 / 70 (5.71%)
    5 / 63 (7.94%)
         occurrences all number
    5
    4
    5
    Dyslipidaemia
         subjects affected / exposed
    5 / 83 (6.02%)
    0 / 70 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    5
    0
    1
    Vitamin D deficiency
         subjects affected / exposed
    2 / 83 (2.41%)
    4 / 70 (5.71%)
    0 / 63 (0.00%)
         occurrences all number
    2
    4
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Feb 2020
    Global version 2.0; Inclusion of local amendments in the global protocol
    22 Apr 2020
    Global Version 3.0: - Enabling of phone visits instead of site visits due to COVID-19 pandemic - Local laboratories are allowed for visits V2 to V8 in case of restrictions due to COVID-19 pandemic
    25 Jan 2021
    Global version 4.0; Change in the time window for screening liver biopsy from 90 to 180 days * Deletion of inclusion criterion 3 (“ALT > 0.8 ULN”) * Additional questions regarding compliance added in the eCRF at V5, V7, and EoT * Estimated number of centres increased from 90 to 120 * Extension of the trial to Asia

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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