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    Clinical Trial Results:
    A Phase 2 randomized, placebo-controlled, double-masked proof-of-concept study to investigate the efficacy and safety off runcaciguat (BAY 1101042) in patients with moderately severe to severe non-proliferative diabetic retinopathy

    Summary
    EudraCT number
    		 2020-002333-15
    Trial protocol
    		 DE   PL   CZ   PT   NL   DK   HU   IT   SK   BG   LV  
    Global end of trial date
    22 Apr 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Apr 2025
    First version publication date
    23 Apr 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20739
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04722991
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser-Wilhelm-Allee, ​Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, +49 30 300139003, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, +49 30 300139003, clinical-trials-contact@bayer.com
    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
    24 Jun 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Apr 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To establish the proof of concept for the efficacy of the soluble guanylyl cyclase (sGC) activator runcaciguat in the treatment of non-proliferative diabetic retinopathy (NPDR)
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects (or their legally authorized representative according to local legislation). Participating subjects (or their legally authorized representative according to local legislation) signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Mar 2021
    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
    Bulgaria: 7
    Country: Number of subjects enrolled
    Czechia: 5
    Country: Number of subjects enrolled
    Denmark: 7
    Country: Number of subjects enrolled
    Latvia: 1
    Country: Number of subjects enrolled
    Netherlands: 2
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    Portugal: 20
    Country: Number of subjects enrolled
    Romania: 1
    Country: Number of subjects enrolled
    Slovakia: 1
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    United Kingdom: 12
    Country: Number of subjects enrolled
    United States: 45
    Worldwide total number of subjects
    109
    EEA total number of subjects
    52
    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)
    77
    From 65 to 84 years
    32
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 39 study centers in Europe and US that randomized 109 participants from 17 MAR 2021 (first patient first visit) to 22 APR 2024 (last patient last visit).

    Pre-assignment
    Screening details
    		 Out of the 224 screened participants, 109 participants were randomized and started treatment. 115 participants did not pass screening. The primary reason for screen failure was that one or more inclusion or exclusion criteria were not met by the participant.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Runcacigat (BAY1101042)
    Arm description
    		 Participants received runcaciguat gastrointestinal therapeutic system (GITS) tablets and were treated following an intra-individual dose-titration design with three titration steps.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Runcacigat
    Investigational medicinal product code
    BAY1101042
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received runcaciguat gastrointestinal therapeutic system (GITS) tablets and were treated following an intra-individual dose-titration design with three titration steps.

    Arm title
    		 Placebo
    Arm description
    		 Participants received matching placebo GITS tablets.
    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
    Participants received matching placebo GITS tablets.

    Number of subjects in period 1
    		Runcacigat (BAY1101042) Placebo
    Started
    56
    53
    Completed
    38
    44
    Not completed
    18
    9
         Adverse event, serious fatal
    2
    -
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    12
    4
         Non-compliance
    -
    1
         Lost to follow-up
    1
    1
         Withdrawal cirterion met
    2
    2
         not specified
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Runcacigat (BAY1101042)
    Reporting group description
    		 Participants received runcaciguat gastrointestinal therapeutic system (GITS) tablets and were treated following an intra-individual dose-titration design with three titration steps.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo GITS tablets.

    Reporting group values
    		 Runcacigat (BAY1101042) Placebo Total
    Number of subjects
    		 56 53 109
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 40 37 77
        From 65-84 years
    		 16 16 32
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 56.4 ( 12.7 ) 57.9 ( 11.5 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 25 22 47
        Male
    		 31 31 62
    Race (NIH/OMB)
    Units: Subjects
        Asian
    		 0 1 1
        Black or African American
    		 2 2 4
        White
    		 54 50 104
    Subject analysis sets

    Subject analysis set title
    FAS (Full Analysis Set)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) included all randomized participants.

    Subject analysis set title
    SAF (Safety Analysis Set)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set (SAF) included all participants who received at least one dose of study intervention, equalling all randomized participants.

    Subject analysis sets values
    		 FAS (Full Analysis Set) SAF (Safety Analysis Set)
    Number of subjects
    109
    109
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    77
    77
        From 65-84 years
    32
    32
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    57.1 ( 12.1 )
    57.1 ( 12.1 )
    Sex: Female, Male
    Units: Subjects
        Female
    47
    47
        Male
    62
    62
    Race (NIH/OMB)
    Units: Subjects
        Asian
    1
    1
        Black or African American
    4
    4
        White
    104
    104

    End points

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    End points reporting groups
    Reporting group title
    Runcacigat (BAY1101042)
    Reporting group description
    		 Participants received runcaciguat gastrointestinal therapeutic system (GITS) tablets and were treated following an intra-individual dose-titration design with three titration steps.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo GITS tablets.

    Subject analysis set title
    FAS (Full Analysis Set)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) included all randomized participants.

    Subject analysis set title
    SAF (Safety Analysis Set)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set (SAF) included all participants who received at least one dose of study intervention, equalling all randomized participants.

    Primary: Percentage of participants with improvement in DRSS by ≥ 2 steps at 48 weeks of treatment in the study eye

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    End point title
    		 Percentage of participants with improvement in DRSS by ≥ 2 steps at 48 weeks of treatment in the study eye
    End point description
    DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study.
    End point type
    Primary
    End point timeframe
    At 48 weeks of treatment
    End point values
    		 Runcacigat (BAY1101042) Placebo
    Number of subjects analysed
    51
    52
    Units: percentage of participants
        number (confidence interval 95%)
    0.0 (0.0 to 4.7)
    1.9 (0.2 to 8.7)
    Statistical analysis title
    		 Statistical analysis (final)
    Comparison groups
    Runcacigat (BAY1101042) v Placebo
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 Point estimate
    Point estimate
    -0.015
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.08
         upper limit
    		 0.029
    Notes
    [1] - Bayesian inference with non-informative priors

    Secondary: Percentage participants with vision threatening complications (VTC) at 48 weeks of treatment in the study eye

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    End point title
    		 Percentage participants with vision threatening complications (VTC) at 48 weeks of treatment in the study eye
    End point description
    VTC are defined as occurrence of any of the following AEs: • Proliferative diabetic retinopathy (PDR) (DRSS ≥61) • Any ocular neo-vascularization (retinal or anterior-segment neovascularization) • Center-involved (central Early Treatment Diabetic Retinopathy Study [ETDRS] subfield) DME • Drop of Best corrected visual acuity (BCVA) of 10 letters or more from baseline
    End point type
    Secondary
    End point timeframe
    At 48 weeks
    End point values
    		 Runcacigat (BAY1101042) Placebo
    Number of subjects analysed
    51
    52
    Units: percentage of participants
        number (not applicable)
    17.6
    11.5
    No statistical analyses for this end point

    Secondary: Percentage of participants with ≥ 2 steps improvement in DRSS at 24 weeks of treatment in the study eye

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    End point title
    		 Percentage of participants with ≥ 2 steps improvement in DRSS at 24 weeks of treatment in the study eye
    End point description
    DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study.
    End point type
    Secondary
    End point timeframe
    At 24 weeks of treatment
    End point values
    		 Runcacigat (BAY1101042) Placebo
    Number of subjects analysed
    51
    52
    Units: percentage of participants
        number (confidence interval 95%)
    0.0 (0.0 to 4.8)
    0.0 (0.0 to 4.7)
    No statistical analyses for this end point

    Secondary: Percentage of participants with ≥ 3 steps improvement in DRSS at 48 weeks of treatment on the for persons scale

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    End point title
    		 Percentage of participants with ≥ 3 steps improvement in DRSS at 48 weeks of treatment on the for persons scale
    End point description
    DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study.
    End point type
    Secondary
    End point timeframe
    At 48 weeks of treatment
    End point values
    		 Runcacigat (BAY1101042) Placebo
    Number of subjects analysed
    51
    52
    Units: percentage of participants
        number (confidence interval 95%)
    0.0 (0.0 to 4.7)
    1.9 (0.2 to 8.7)
    No statistical analyses for this end point

    Secondary: Number of participants with treatment emergent adverse event (TEAE)

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    End point title
    		 Number of participants with treatment emergent adverse event (TEAE)
    End point description
    End point type
    Secondary
    End point timeframe
    From first dosing up to 28 days after last dose of study intervention
    End point values
    		 Runcacigat (BAY1101042) Placebo
    Number of subjects analysed
    56
    53
    Units: number of participants
    53
    44
    No statistical analyses for this end point

    Other pre-specified: Percentage of participants with < 3 steps deterioration in DRSS at 48 weeks of treatment on the for persons scale

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    End point title
    		 Percentage of participants with < 3 steps deterioration in DRSS at 48 weeks of treatment on the for persons scale
    End point description
    DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study.
    End point type
    Other pre-specified
    End point timeframe
    At 48 weeks of treatment
    End point values
    		 Runcacigat (BAY1101042) Placebo
    Number of subjects analysed
    51
    52
    Units: percentage of participants
        number (confidence interval 95%)
    78.4 (65.8 to 88.0)
    80.8 (68.5 to 89.7)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dosing up to 28 days after last dose of study intervention.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Runcaciguat (BAY1101042)
    Reporting group description
    		 Participants received Runcaciguat 15 mg gastrointestinal therapeutic system (GITS) tablets and were treated following an intra-individual dose-titration design with three titration steps with four dose levels (30, 60, 90, 120 mg)

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo GITS tablets and were treated following an intra-individual dose-titration design with three titration steps with four dose levels

    Serious adverse events
    		 Runcaciguat (BAY1101042) Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 56 (16.07%)
    3 / 53 (5.66%)
         number of deaths (all causes)
    2
    0
         number of deaths resulting from adverse events
    2
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive ductal breast carcinoma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral artery thrombosis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dry gangrene
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Psychiatric disorders
    Depression
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Hypoxic-ischaemic encephalopathy
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Visual acuity reduced
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Lower gastrointestinal haemorrhage
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Plantar fasciitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Diabetic foot infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal sepsis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Septic shock
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected skin ulcer
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Runcaciguat (BAY1101042) Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    50 / 56 (89.29%)
    32 / 53 (60.38%)
    Investigations
    Glomerular filtration rate decreased
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 56 (7.14%)
    2 / 53 (3.77%)
         occurrences all number
    4
    2
    Blood creatinine increased
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 56 (7.14%)
    2 / 53 (3.77%)
         occurrences all number
    4
    2
    Aspartate aminotransferase increased
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 53 (0.00%)
         occurrences all number
    3
    0
    Vascular disorders
    Hypertension
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 56 (3.57%)
    4 / 53 (7.55%)
         occurrences all number
    2
    4
    Hypotension
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 56 (7.14%)
    1 / 53 (1.89%)
         occurrences all number
    4
    1
    Nervous system disorders
    Dizziness
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 56 (10.71%)
    2 / 53 (3.77%)
         occurrences all number
    12
    6
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 56 (10.71%)
    4 / 53 (7.55%)
         occurrences all number
    24
    4
    Blood and lymphatic system disorders
    Anaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 56 (5.36%)
    2 / 53 (3.77%)
         occurrences all number
    3
    2
    Erythropenia
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 53 (0.00%)
         occurrences all number
    3
    0
    General disorders and administration site conditions
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 56 (7.14%)
    1 / 53 (1.89%)
         occurrences all number
    4
    1
    Eye disorders
    Retinal haemorrhage
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 56 (5.36%)
    2 / 53 (3.77%)
         occurrences all number
    3
    2
    Retinal exudates
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 53 (0.00%)
         occurrences all number
    3
    0
    Dry eye
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 53 (5.66%)
         occurrences all number
    1
    3
    Diabetic retinopathy
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 56 (5.36%)
    2 / 53 (3.77%)
         occurrences all number
    3
    2
    Diabetic retinal oedema
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 56 (3.57%)
    3 / 53 (5.66%)
         occurrences all number
    2
    4
    Vision blurred
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 53 (0.00%)
         occurrences all number
    4
    0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 56 (3.57%)
    3 / 53 (5.66%)
         occurrences all number
    3
    3
    Diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    16 / 56 (28.57%)
    10 / 53 (18.87%)
         occurrences all number
    28
    17
    Constipation
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 53 (0.00%)
         occurrences all number
    3
    0
    Abdominal pain upper
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 56 (5.36%)
    2 / 53 (3.77%)
         occurrences all number
    5
    2
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 56 (7.14%)
    5 / 53 (9.43%)
         occurrences all number
    5
    7
    Nausea
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 56 (10.71%)
    5 / 53 (9.43%)
         occurrences all number
    7
    5
    Psychiatric disorders
    Depression
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 56 (7.14%)
    0 / 53 (0.00%)
         occurrences all number
    4
    0
    Musculoskeletal and connective tissue disorders
    Back pain
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 56 (8.93%)
    0 / 53 (0.00%)
         occurrences all number
    5
    0
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 53 (1.89%)
         occurrences all number
    4
    1
    Pain in extremity
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 56 (7.14%)
    0 / 53 (0.00%)
         occurrences all number
    4
    0
    Arthralgia
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 56 (3.57%)
    3 / 53 (5.66%)
         occurrences all number
    2
    3
    Infections and infestations
    COVID-19
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 56 (8.93%)
    4 / 53 (7.55%)
         occurrences all number
    5
    4
    Tooth infection
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 56 (7.14%)
    1 / 53 (1.89%)
         occurrences all number
    4
    1
    Urinary tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 53 (0.00%)
         occurrences all number
    3
    0
    Upper respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 53 (5.66%)
         occurrences all number
    1
    3
    Nasopharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 56 (7.14%)
    0 / 53 (0.00%)
         occurrences all number
    5
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Nov 2020
    Amendment 1- This amendment was implemented to follow requests from the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) and central Independent Ethics Committee (IEC). Changes were made to the following protocol sections: Run in, Exclusion criteria, Intra-individual dose-titration decisions, Stopping rules (study level), Permanent discontinuation, Vision threatening complications, Genetics, Biomarkers, Safety assessment group, Central reading centers
    13 Jan 2021
    Amendment 2 - This amendment was implemented to accommodate requests by Competent Authorities and Independent Ethics Committees on the use of the smartphone app to support drug adherence. In addition, endpoint assessments were specified and additional endpoints included. Changes were made to the following protocol sections: Electrocardiograms, Study intervention compliance, Color fungus photography (CFP), Optical coherence tomogrpahy angiography (OCT-A)
    04 Nov 2021
    Amendment 3 - Due to product development reasons, the study was restrucutred. The Terms Part A and Part B were retired. Part 1 now referred to the PK/PD substudy and Part 2 referred to the main part of the PoC study. Changes were made throughout the entire protocol, affecting all sections.
    09 Feb 2023
    Amendment 4 - Clarifications were made of dose-titration instructions changes to the primary endpoint assessment, making this amendment substantial. Changes were made to the following protocol sections: Synopsis, Schema, Objectives and endpoints, Overall design, Scientific rationale for study design, End-of-study definition, Study assessments and procedures, Statistical hypotheses, Primary endpoint, Efficacy, Risk assessment, Intra-individual dose-titration decisions, Part 2- Proof of concept, Pharmacokinetics, Interim analysis, Re-challenge / re-start of study intervention, Permanent discontinuation

    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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