Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    An open-label extension study to investigate efficacy, safety and tolerability of LTP001 in participants with pulmonary arterial hypertension

    Summary
    EudraCT number
    		 2022-002007-38
    Trial protocol
    		 ES   NL  
    Global end of trial date
    14 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 May 2025
    First version publication date
    08 May 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CLTP001A12201E1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05764265
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.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
    14 May 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 May 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective was to assess the long-term safety of LTP001 in participants with pulmonary arterial hypertension (PAH). Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Mar 2023
    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
    Argentina: 3
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Netherlands: 4
    Country: Number of subjects enrolled
    Poland: 7
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    United States: 1
    Worldwide total number of subjects
    31
    EEA total number of subjects
    24
    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)
    27
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 31 participants who completed the parent study up to the end of treatment were screened for the extension study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LTP001 6 mg (Actual Treatment in CLTP001A12201)
    Arm description
    		 Participants had received LTP001, 6 mg, in Study CLTP001A12201, and continued to receive LTP001, 6 mg, orally once daily in the morning for approximately 52 weeks in this extension study
    Arm type
    		 Experimental

    Investigational medicinal product name
    LTP001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received LTP001, 6 mg, orally once daily in the morning for approximately 52 weeks

    Arm title
    		 LTP001 6 mg (Placebo in CLTP001A12201)
    Arm description
    		 Participants had received placebo in Study CLTP001A12201, followed by LTP001, 6 mg, orally once daily in the morning for approximately 52 weeks in this extension study
    Arm type
    		 Experimental

    Investigational medicinal product name
    LTP001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received LTP001, 6 mg, orally once daily in the morning for approximately 52 weeks

    Number of subjects in period 1
    		LTP001 6 mg (Actual Treatment in CLTP001A12201) LTP001 6 mg (Placebo in CLTP001A12201)
    Started
    23
    8
    Completed
    0
    0
    Not completed
    23
    8
         Participant Decision
    1
    -
         Physician decision
    1
    8
         Adverse event, non-fatal
    1
    -
         Study Terminated By Sponsor
    20
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    LTP001 6 mg (Actual Treatment in CLTP001A12201)
    Reporting group description
    		 Participants had received LTP001, 6 mg, in Study CLTP001A12201, and continued to receive LTP001, 6 mg, orally once daily in the morning for approximately 52 weeks in this extension study

    Reporting group title
    LTP001 6 mg (Placebo in CLTP001A12201)
    Reporting group description
    		 Participants had received placebo in Study CLTP001A12201, followed by LTP001, 6 mg, orally once daily in the morning for approximately 52 weeks in this extension study

    Reporting group values
    		 LTP001 6 mg (Actual Treatment in CLTP001A12201) LTP001 6 mg (Placebo in CLTP001A12201) Total
    Number of subjects
    		 23 8 31
    Age Categorical
    Units: Participants
        18 - <65
    		 20 7 27
        65 - <85
    		 3 1 4
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 47.0 ( 11.76 ) 48.4 ( 13.35 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 21 6 27
        Male
    		 2 2 4
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 21 7 28
        American Indian or Alaskan
    		 2 0 2
        Asian
    		 0 1 1

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    LTP001 6 mg (Actual Treatment in CLTP001A12201)
    Reporting group description
    		 Participants had received LTP001, 6 mg, in Study CLTP001A12201, and continued to receive LTP001, 6 mg, orally once daily in the morning for approximately 52 weeks in this extension study

    Reporting group title
    LTP001 6 mg (Placebo in CLTP001A12201)
    Reporting group description
    		 Participants had received placebo in Study CLTP001A12201, followed by LTP001, 6 mg, orally once daily in the morning for approximately 52 weeks in this extension study

    Primary: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    		 Close Top of page
    End point title
    		 Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [1]
    End point description
    Incidence and severity of adverse events (AEs) by treatment group, including changes in the vital signs, electrocardiogram and laboratory results qualifying and reported as AEs.
    End point type
    Primary
    End point timeframe
    52 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics are reported.
    End point values
    		 LTP001 6 mg (Actual Treatment in CLTP001A12201) LTP001 6 mg (Placebo in CLTP001A12201)
    Number of subjects analysed
    23
    8
    Units: Percentage of participants
    number (not applicable)
        AEs
    52.2
    62.5
        Serious AEs
    17.4
    0
    No statistical analyses for this end point

    Secondary: Change From Baseline in Average Cardiac Output (CO) at Week 26

    		 Close Top of page
    End point title
    		 Change From Baseline in Average Cardiac Output (CO) at Week 26
    End point description
    Right heart catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including CO.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    End point values
    		 LTP001 6 mg (Actual Treatment in CLTP001A12201) LTP001 6 mg (Placebo in CLTP001A12201)
    Number of subjects analysed
    6
    2
    Units: liters per minute
        arithmetic mean (standard deviation)
    -0.111 ( 0.2153 )
    -0.065 ( 0.5916 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Mean Pulmonary Artery (PA) Pressure at Week 26

    		 Close Top of page
    End point title
    		 Change From Baseline in Mean Pulmonary Artery (PA) Pressure at Week 26
    End point description
    Right heart catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including PA pressure.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    End point values
    		 LTP001 6 mg (Actual Treatment in CLTP001A12201) LTP001 6 mg (Placebo in CLTP001A12201)
    Number of subjects analysed
    6
    2
    Units: mmHg
        arithmetic mean (standard deviation)
    3.8 ( 8.18 )
    -1.5 ( 7.78 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Week 26

    		 Close Top of page
    End point title
    		 Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Week 26
    End point description
    Right heart catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including pulmonary capillary wedge pressure (PCWP).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    End point values
    		 LTP001 6 mg (Actual Treatment in CLTP001A12201) LTP001 6 mg (Placebo in CLTP001A12201)
    Number of subjects analysed
    6
    2
    Units: mmHg
        arithmetic mean (standard deviation)
    -1.0 ( 1.79 )
    -0.5 ( 0.71 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Right Heart Catheterization Pulmonary Vascular Resistance (PVR) at Week 26

    		 Close Top of page
    End point title
    		 Change From Baseline in Right Heart Catheterization Pulmonary Vascular Resistance (PVR) at Week 26
    End point description
    PVR was defined as the resistance against blood flow from the pulmonary artery to the left atrium measured in dynes.sec.cm-5.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    End point values
    		 LTP001 6 mg (Actual Treatment in CLTP001A12201) LTP001 6 mg (Placebo in CLTP001A12201)
    Number of subjects analysed
    6
    2
    Units: dynes.sec.cm-5
        arithmetic mean (standard deviation)
    100.058 ( 95.5879 )
    -7.445 ( 34.8250 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Right Atrium (RA) Pressures at Week 26

    		 Close Top of page
    End point title
    		 Change From Baseline in Right Atrium (RA) Pressures at Week 26
    End point description
    The Right Heart Catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including RA pressures.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    End point values
    		 LTP001 6 mg (Actual Treatment in CLTP001A12201) LTP001 6 mg (Placebo in CLTP001A12201)
    Number of subjects analysed
    6
    2
    Units: mmHg
        arithmetic mean (standard deviation)
    -1.5 ( 6.22 )
    0.0 ( 2.83 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Systemic Vascular Resistance (SVR) at Week 26

    		 Close Top of page
    End point title
    		 Change From Baseline in Systemic Vascular Resistance (SVR) at Week 26
    End point description
    The Right Heart Catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including SVR.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    End point values
    		 LTP001 6 mg (Actual Treatment in CLTP001A12201) LTP001 6 mg (Placebo in CLTP001A12201)
    Number of subjects analysed
    6
    2
    Units: dynes.sec.cm-5
        arithmetic mean (standard deviation)
    166.748 ( 128.6202 )
    -49.710 ( 28.5388 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Six Minute Walk Distance (6MWD)

    		 Close Top of page
    End point title
    		 Change From Baseline in Six Minute Walk Distance (6MWD)
    End point description
    6MWD test measures the distance that a participant can walk on a flat, hard surface in a period of 6 minutes.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26, Week 52
    End point values
    		 LTP001 6 mg (Actual Treatment in CLTP001A12201) LTP001 6 mg (Placebo in CLTP001A12201)
    Number of subjects analysed
    16
    2
    Units: meters
    arithmetic mean (standard deviation)
        Week 26 n=6,2
    -33.7 ( 55.60 )
    -9.0 ( 25.46 )
        End of Treatment n=16,2
    -6.3 ( 50.21 )
    -1.0 ( 1.41 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE)

    		 Close Top of page
    End point title
    		 Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE)
    End point description
    Key right ventricular (RV) function endpoints such as tricuspid annular plane systolic excursion (TAPSE) were assessed with echocardiography.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26, Week 52
    End point values
    		 LTP001 6 mg (Actual Treatment in CLTP001A12201) LTP001 6 mg (Placebo in CLTP001A12201)
    Number of subjects analysed
    7
    2
    Units: centimeters
    arithmetic mean (standard deviation)
        Week 26 n=6,2
    0.03 ( 0.175 )
    0.00 ( 0.283 )
        End of Treatment n=7,0
    0.01 ( 0.682 )
    999 ( 999 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Tricuspid Annular Plane Systolic Velocity (TASV)

    		 Close Top of page
    End point title
    		 Change From Baseline in Tricuspid Annular Plane Systolic Velocity (TASV)
    End point description
    Key right ventricular (RV) function endpoints such as tricuspid annular systolic velocity (TASV) were assessed with echocardiography.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26, Week 52
    End point values
    		 LTP001 6 mg (Actual Treatment in CLTP001A12201) LTP001 6 mg (Placebo in CLTP001A12201)
    Number of subjects analysed
    7
    2
    Units: centimeters per second
    arithmetic mean (standard deviation)
        Week 26 n=6,2
    -2.2 ( 3.43 )
    -0.5 ( 0.71 )
        End of Treatment n=7,0
    -2.6 ( 1.90 )
    999 ( 999 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Peak Velocity of Excursion (RV S’)

    		 Close Top of page
    End point title
    		 Change From Baseline in Peak Velocity of Excursion (RV S’)
    End point description
    Key right ventricular (RV) function per echocardiography. The terms Tricuspid Annular Systolic Velocity (TASV) and Peak Velocity of Excursion (RV S’) are synonymous in echocardiography to describe the peak systolic velocity of the lateral tricuspid annulus. Including both TASV and RV S’ as separate secondary endpoints was an oversight in the protocol as the data, calculation, and analyses for both (TASV and RV S’) are identical. Therefore, the TASV and RV S’ data in this results disclosure are the same.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26, Week 52
    End point values
    		 LTP001 6 mg (Actual Treatment in CLTP001A12201) LTP001 6 mg (Placebo in CLTP001A12201)
    Number of subjects analysed
    7
    2
    Units: centimeters per second
    arithmetic mean (standard deviation)
        Week 26 n=6,2
    -2.2 ( 3.43 )
    -0.5 ( 0.71 )
        End of Treatment n=7,0
    -2.6 ( 1.90 )
    999 ( 999 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fractional Area Change (FAC)

    		 Close Top of page
    End point title
    		 Change From Baseline in Fractional Area Change (FAC)
    End point description
    Key right ventricular (RV) function endpoints such as RV fractional area change (RV FAC) were assessed with echocardiography.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26, Week 52
    End point values
    		 LTP001 6 mg (Actual Treatment in CLTP001A12201) LTP001 6 mg (Placebo in CLTP001A12201)
    Number of subjects analysed
    6
    1
    Units: percent
    arithmetic mean (standard deviation)
        Week 26 n=6,1
    -0.87 ( 6.162 )
    7.30 ( 999 )
        End of Treatment n=6,0
    0.97 ( 5.290 )
    999 ( 999 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Quality of Life Measured by the emPHasis-10 Questionnaire

    		 Close Top of page
    End point title
    		 Change From Baseline in Quality of Life Measured by the emPHasis-10 Questionnaire
    End point description
    emPHasis-10 is a questionnaire with 10 questions designed to determine how pulmonary hypertension affects a participant's life. Each item is scored on a scale of 0 to 5, with a total score ranging from 0 to 50. A higher score indicates worse quality of life.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52
    End point values
    		 LTP001 6 mg (Actual Treatment in CLTP001A12201) LTP001 6 mg (Placebo in CLTP001A12201)
    Number of subjects analysed
    3
    1
    Units: score
        arithmetic mean (standard deviation)
    1.476 ( 2.3226 )
    1.000 ( 999 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Quality of Life Measured by the PAH-SYMPACT Questionnaire

    		 Close Top of page
    End point title
    		 Change From Baseline in Quality of Life Measured by the PAH-SYMPACT Questionnaire
    End point description
    PAH-SYMPACT is a questionnaire used to assess pulmonary arterial hypertension symptoms and their impact. Individual item scores range from 0 to 4. Total score is calculated as the sum of the scores for the individual items divided by the number of items. A higher score indicates more severe symptoms/impacts.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52
    End point values
    		 LTP001 6 mg (Actual Treatment in CLTP001A12201) LTP001 6 mg (Placebo in CLTP001A12201)
    Number of subjects analysed
    2
    1
    Units: score
        arithmetic mean (standard deviation)
    2.929 ( 2.3234 )
    -0.833 ( 999 )
    No statistical analyses for this end point

    Secondary: Time to Clinical Worsening

    		 Close Top of page
    End point title
    		 Time to Clinical Worsening
    End point description
    Time to any of the following: - Death - Hospital stay greater than 24 hours due to worsening of pulmonary arterial hypertension - Worsening of PAH resulting in need for lung transplantation or balloon atrial septostomy - Initiation of parenteral prostanoid therapy, initiation of oxygen therapy, initiation of any other pulmonary arterial hypertension-specific therapies or need for increase of diuretics for more than 4 weeks due to worsening of pulmonary arterial hypertension - Significant drop in six-minute walk distance
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52
    End point values
    		 LTP001 6 mg (Actual Treatment in CLTP001A12201) LTP001 6 mg (Placebo in CLTP001A12201)
    Number of subjects analysed
    6
    0 [2]
    Units: days
        median (confidence interval 95%)
    346.0 (187.0 to 999)
    ( to )
    Notes
    [2] - There were no participants with available data.
    No statistical analyses for this end point

    Secondary: Change From Baseline in N-terminal Fragment of the Prohormone B-type Natriuretic Peptide (NT-ProBNP)

    		 Close Top of page
    End point title
    		 Change From Baseline in N-terminal Fragment of the Prohormone B-type Natriuretic Peptide (NT-ProBNP)
    End point description
    NT-proBNP is a blood biomarker to assess right ventricular distress.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52
    End point values
    		 LTP001 6 mg (Actual Treatment in CLTP001A12201) LTP001 6 mg (Placebo in CLTP001A12201)
    Number of subjects analysed
    19
    6
    Units: picomoles per liter
        arithmetic mean (standard deviation)
    3.832 ( 31.2255 )
    7.250 ( 16.6033 )
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    LTP001 6 mg (TRT in LTP001A12201)
    Reporting group description
    		 LTP001 6 mg (TRT in LTP001A12201)

    Reporting group title
    Total
    Reporting group description
    		 Total

    Reporting group title
    LTP001 6 mg (PBO in LTP001A12201)
    Reporting group description
    		 LTP001 6 mg (PBO in LTP001A12201)

    Serious adverse events
    		 LTP001 6 mg (TRT in LTP001A12201) Total LTP001 6 mg (PBO in LTP001A12201)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 23 (17.39%)
    4 / 31 (12.90%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    General disorders and administration site conditions
    Medical device site haemorrhage
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 31 (3.23%)
    0 / 8 (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
    Respiratory, thoracic and mediastinal disorders
    Pulmonary arterial hypertension
         subjects affected / exposed
    2 / 23 (8.70%)
    2 / 31 (6.45%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Device related infection
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 31 (3.23%)
    0 / 8 (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
    Disseminated gonococcal infection
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 31 (3.23%)
    0 / 8 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 LTP001 6 mg (TRT in LTP001A12201) Total LTP001 6 mg (PBO in LTP001A12201)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 23 (21.74%)
    10 / 31 (32.26%)
    5 / 8 (62.50%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 31 (3.23%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    Headache
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 31 (6.45%)
    1 / 8 (12.50%)
         occurrences all number
    1
    3
    2
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 31 (3.23%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 31 (3.23%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    Eye disorders
    Eczema eyelids
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 31 (3.23%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 31 (3.23%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    Nasal congestion
         subjects affected / exposed
    2 / 23 (8.70%)
    2 / 31 (6.45%)
    0 / 8 (0.00%)
         occurrences all number
    2
    2
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 31 (3.23%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 23 (8.70%)
    2 / 31 (6.45%)
    0 / 8 (0.00%)
         occurrences all number
    2
    2
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 31 (3.23%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 31 (3.23%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    Infections and infestations
    Tooth abscess
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 31 (3.23%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 23 (8.70%)
    3 / 31 (9.68%)
    1 / 8 (12.50%)
         occurrences all number
    2
    3
    1
    Bronchitis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 31 (3.23%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    Bartholinitis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 31 (3.23%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jan 2023
    This amendment: incorporated safety follow-up visits at Weeks 9 and 17; updated the protocol appendix and Safety Assessments table with further guidance for renal alert criteria and follow-up guidelines; removed Inclusion Criterion 4 to avoid the exclusion of participants who may have progressed on placebo; corrected for administrative inconsistencies and added further protocol clarifications to ensure data quality.

    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.
    Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 09 17:51:03 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA