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    Clinical Trial Results:
    A multi-centre, randomised, double-blind placebo-controlled, Phase 2 study to investigate efficacy, safety and tolerability of SLN360 in participants with elevated lipoprotein(a) at high risk of atherosclerotic cardiovascular disease events

    Summary
    EudraCT number
    		 2022-001876-32
    Trial protocol
    		 ES   NL   SK   DK   CZ  
    Global end of trial date
    01 Jul 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jun 2025
    First version publication date
    14 Jun 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SLN360-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05537571
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Silence Therapeutics plc
    Sponsor organisation address
    72 Hammersmith Road, London, United Kingdom, W14 8TH
    Public contact
    Global Regulatory, Silence Therapeutics plc, global-regulatory@silence-therapeutics.com
    Scientific contact
    Global Regulatory, Silence Therapeutics plc, global-regulatory@silence-therapeutics.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
    16 Jul 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jul 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the effect of SLN360 on circulating levels of lipoprotein(a) in participants with elevated lipoprotein(a) at high risk of ASCVD events.
    Protection of trial subjects
    This study was conducted in accordance with International Council for Harmonisation Good Clinical Practice regulations/guidelines.
    Background therapy
    		 Participants received standard of care stable doses of lipid-modifying therapy during the trial.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Dec 2022
    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
    Netherlands: 60
    Country: Number of subjects enrolled
    Slovakia: 5
    Country: Number of subjects enrolled
    Czechia: 11
    Country: Number of subjects enrolled
    Denmark: 25
    Country: Number of subjects enrolled
    United Kingdom: 32
    Country: Number of subjects enrolled
    Australia: 18
    Country: Number of subjects enrolled
    South Africa: 29
    Worldwide total number of subjects
    180
    EEA total number of subjects
    101
    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)
    92
    From 65 to 84 years
    88
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were screened from 05 December 2022, first randomised participant signed informed consent on 13 December 2022 and last participant was randomised 27 April 2023.

    Pre-assignment
    Screening details
    		 A total of 253 participants were screened for inclusion, 73 participants failed screening.

    Pre-assignment period milestones
    Number of subjects started
    		 253 [1]
    Number of subjects completed
    		 180 [2]

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Adverse event, non-fatal: 2
    Reason: Number of subjects
    		 Consent withdrawn by subject: 1
    Reason: Number of subjects
    		 Other: 4
    Reason: Number of subjects
    		 Failure to meet randomisation criteria: 66
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The worldwide number includes enrolled participants whereas the pre-assignment period includes participants who failed screening and were not enrolled.
    [2] - The number of subjects reported to be in the pre-assignment period is not consistent with the number starting period 1. It is expected that the number completing the pre-assignment period are also present in the arms in period 1.
    Justification: The pre-assignment period represents the screening period, reasons for non-completion are provided. The 180 participants included in period 1 include those participants who did not fail screening and who were enrolled and randomised.
    Period 1
    Period 1 title
    Overall trial
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    Following the completion of 36 weeks, limited members from the Sponsor team were unblinded. The nature of the treatment supply meant that the pharmacist was unblinded with appropriate unblinded oversight in place.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Placebo Q16W
    Arm description
    		 Placebo administered subcutaneously at Weeks 0, 16 and 32 (dosing every 16 weeks [Q16W]).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection.

    Arm title
    		 Placebo Q24W
    Arm description
    		 Placebo administered subcutaneously at Weeks 0 and 24 (dosing every 24 weeks [Q24W]). This group was stratified so that half of participants were dosed to match the SLN360 300 mg Q24W group and half were dosed to match the SLN360 450 mg Q24W group (with respect to injected volume).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection.

    Arm title
    		 SLN360 300 mg Q16W
    Arm description
    		 SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zerlasiran
    Investigational medicinal product code
    SLN360
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection.

    Arm title
    		 SLN360 300 mg Q24W
    Arm description
    		 SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zerlasiran
    Investigational medicinal product code
    SLN360
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection.

    Arm title
    		 SLN360 450 mg Q24W
    Arm description
    		 SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zerlasiran
    Investigational medicinal product code
    SLN360
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection.

    Arm title
    		 Pooled placebo
    Arm description
    		 Pooled data from both placebo groups.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection.

    Number of subjects in period 1
    		Placebo Q16W Placebo Q24W SLN360 300 mg Q16W SLN360 300 mg Q24W SLN360 450 mg Q24W Pooled placebo
    Started
    23
    24
    44
    44
    45
    47
    Treated
    23
    24
    42
    44
    45
    47
    Completed
    23
    23
    39
    43
    44
    46
    Not completed
    0
    1
    5
    1
    1
    1
         Consent withdrawn by subject
    -
    -
    1
    1
    -
    -
         Adverse event, non-fatal
    -
    -
    2
    -
    -
    -
         Lost to follow-up
    -
    1
    -
    -
    1
    1
         Hepatitis A screening result
    -
    -
    2
    -
    -
    -
    Period 2
    Period 2 title
    Treatment and follow-up
    Is this the baseline period?
    		 Yes [3]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    Following the completion of 36 weeks, limited members from the Sponsor team were unblinded. The nature of the treatment supply meant that the pharmacist was unblinded with appropriate unblinded oversight in place.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Placebo Q16W
    Arm description
    		 Placebo administered subcutaneously at Weeks 0, 16 and 32 (dosing every 16 weeks [Q16W]).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection.

    Arm title
    		 Placebo Q24W
    Arm description
    		 Placebo administered subcutaneously at Weeks 0 and 24 (dosing every 24 weeks [Q24W]). This group was stratified so that half of participants were dosed to match the SLN360 300 mg Q24W group and half were dosed to match the SLN360 450 mg Q24W group (with respect to injected volume).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection.

    Arm title
    		 SLN360 300 mg Q16W
    Arm description
    		 SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zerlasiran
    Investigational medicinal product code
    SLN360
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection.

    Arm title
    		 SLN360 300 mg Q24W
    Arm description
    		 SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zerlasiran
    Investigational medicinal product code
    SLN360
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection.

    Arm title
    		 SLN360 450 mg Q24W
    Arm description
    		 SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zerlasiran
    Investigational medicinal product code
    SLN360
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection.

    Arm title
    		 Pooled placebo
    Arm description
    		 Pooled data from both placebo groups.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection.

    Notes
    [3] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Of the 180 enrolled and randomised participants, 2 participants randomised to the SLN360 300 mg Q16W group were untreated because both participants were determined to be ineligible before study drug could be administered due to hepatitis A screening results; both participants were terminated early from the study, rescreened and underwent a second randomisation, following which the participants were treated with SLN360 300 mg Q16W and SLN360 300 mg Q24W, respectively.
    Number of subjects in period 2
    		Placebo Q16W Placebo Q24W SLN360 300 mg Q16W SLN360 300 mg Q24W SLN360 450 mg Q24W Pooled placebo
    Started
    23
    24
    42
    44
    45
    47
    Completed
    23
    23
    39
    43
    44
    46
    Not completed
    0
    1
    3
    1
    1
    1
         Consent withdrawn by subject
    -
    -
    1
    1
    -
    -
         Adverse event, non-fatal
    -
    -
    2
    -
    -
    -
         Lost to follow-up
    -
    1
    -
    -
    1
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups [1]
    Reporting group title
    Placebo Q16W
    Reporting group description
    		 Placebo administered subcutaneously at Weeks 0, 16 and 32 (dosing every 16 weeks [Q16W]).

    Reporting group title
    Placebo Q24W
    Reporting group description
    		 Placebo administered subcutaneously at Weeks 0 and 24 (dosing every 24 weeks [Q24W]). This group was stratified so that half of participants were dosed to match the SLN360 300 mg Q24W group and half were dosed to match the SLN360 450 mg Q24W group (with respect to injected volume).

    Reporting group title
    SLN360 300 mg Q16W
    Reporting group description
    		 SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W).

    Reporting group title
    SLN360 300 mg Q24W
    Reporting group description
    		 SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W).

    Reporting group title
    SLN360 450 mg Q24W
    Reporting group description
    		 SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W).

    Reporting group title
    Pooled placebo
    Reporting group description
    		 Pooled data from both placebo groups.

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The baseline data are based on the set of unique participants who were randomised and treated, this excludes 2 participant numbers that enrolled but were not treated, but were later rescreened and re-randomised / treated. The worldwide number of participants is based on all allocated participant numbers enrolled rather than unique participants.
    Reporting group values
    		 Placebo Q16W Placebo Q24W SLN360 300 mg Q16W SLN360 300 mg Q24W SLN360 450 mg Q24W Pooled placebo Total
    Number of subjects
    		 23 24 42 44 45 47 178
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 12 15 19 23 22 27 91
        From 65-84 years
    		 11 9 23 21 23 20 87
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.0 ( 8.79 ) 62.1 ( 9.43 ) 63.1 ( 9.81 ) 64.5 ( 8.67 ) 63.8 ( 10.23 ) 63.6 ( 9.14 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 6 11 13 11 11 46
        Male
    		 18 18 31 31 34 36 132
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 23 24 42 44 45 47 178
    Race
    Units: Subjects
        Asian
    		 0 1 1 2 4 1 8
        Black or African American
    		 0 0 1 0 2 0 3
        White
    		 21 22 38 36 36 43 153
        Other
    		 2 1 2 6 3 3 14

    End points

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    End points reporting groups
    Reporting group title
    Placebo Q16W
    Reporting group description
    		 Placebo administered subcutaneously at Weeks 0, 16 and 32 (dosing every 16 weeks [Q16W]).

    Reporting group title
    Placebo Q24W
    Reporting group description
    		 Placebo administered subcutaneously at Weeks 0 and 24 (dosing every 24 weeks [Q24W]). This group was stratified so that half of participants were dosed to match the SLN360 300 mg Q24W group and half were dosed to match the SLN360 450 mg Q24W group (with respect to injected volume).

    Reporting group title
    SLN360 300 mg Q16W
    Reporting group description
    		 SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W).

    Reporting group title
    SLN360 300 mg Q24W
    Reporting group description
    		 SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W).

    Reporting group title
    SLN360 450 mg Q24W
    Reporting group description
    		 SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W).

    Reporting group title
    Pooled placebo
    Reporting group description
    		 Pooled data from both placebo groups.
    Reporting group title
    Placebo Q16W
    Reporting group description
    		 Placebo administered subcutaneously at Weeks 0, 16 and 32 (dosing every 16 weeks [Q16W]).

    Reporting group title
    Placebo Q24W
    Reporting group description
    		 Placebo administered subcutaneously at Weeks 0 and 24 (dosing every 24 weeks [Q24W]). This group was stratified so that half of participants were dosed to match the SLN360 300 mg Q24W group and half were dosed to match the SLN360 450 mg Q24W group (with respect to injected volume).

    Reporting group title
    SLN360 300 mg Q16W
    Reporting group description
    		 SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W).

    Reporting group title
    SLN360 300 mg Q24W
    Reporting group description
    		 SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W).

    Reporting group title
    SLN360 450 mg Q24W
    Reporting group description
    		 SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W).

    Reporting group title
    Pooled placebo
    Reporting group description
    		 Pooled data from both placebo groups.

    Primary: Time-averaged percent change in lipoprotein(a) molar concentration from baseline to Week 36

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    End point title
    		 Time-averaged percent change in lipoprotein(a) molar concentration from baseline to Week 36
    End point description
    In calculating the primary outcome measure, the time-averaged percent change in lipoprotein(a) (relative to Day 1 pre‑dose) was calculated for each participant by estimating the sum of the area under the curve with the linear trapezoidal method for all scheduled assessments from Week 4 to Week 36, inclusive, divided by the total time interval between the Week 4 and Week 36 assessments. Analysis of variance was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure. Time-averaged percent change in lipoprotein(a) to Week 36 was the dependent variable, and treatment group was included as the predictor variable. The least squares (LS) means, standard errors, and 2-sided 95% confidence intervals (CIs) for each treatment group and for the pairwise comparisons between the SLN360 and placebo groups were estimated.
    End point type
    Primary
    End point timeframe
    Week 36 relative to baseline
    End point values
    		 SLN360 300 mg Q16W SLN360 300 mg Q24W SLN360 450 mg Q24W Pooled placebo
    Number of subjects analysed
    42
    44
    45
    47
    Units: Percentage
        least squares mean (standard error)
    -80.5 ( 1.99 )
    -79.1 ( 1.94 )
    -83.3 ( 1.92 )
    2.3 ( 1.88 )
    Statistical analysis title
    		 Analysis of variance for the primary endpoint
    Statistical analysis description
    Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.
    Comparison groups
    Pooled placebo v SLN360 300 mg Q16W
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -82.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -88.19
         upper limit
    		 -77.39
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Analysis of variance for the primary endpoint
    Statistical analysis description
    Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.
    Comparison groups
    SLN360 300 mg Q24W v Pooled placebo
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -81.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -86.68
         upper limit
    		 -76
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Analysis of variance for the primary endpoint
    Statistical analysis description
    Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.
    Comparison groups
    SLN360 450 mg Q24W v Pooled placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -85.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -90.88
         upper limit
    		 -80.26

    Secondary: Time-averaged percent change in lipoprotein(a) molar concentration from baseline to Week 48

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    End point title
    		 Time-averaged percent change in lipoprotein(a) molar concentration from baseline to Week 48
    End point description
    Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Week 48 relative to baseline
    End point values
    		 SLN360 300 mg Q16W SLN360 300 mg Q24W SLN360 450 mg Q24W Pooled placebo
    Number of subjects analysed
    42
    44
    45
    47
    Units: Percentage
        least squares mean (standard error)
    -81.6 ( 2.05 )
    -77.2 ( 2.00 )
    -81.5 ( 1.98 )
    1.5 ( 1.94 )
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    SLN360 300 mg Q16W v Pooled placebo
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -83.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -88.7
         upper limit
    		 -77.57
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    Pooled placebo v SLN360 300 mg Q24W
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -78.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -84.18
         upper limit
    		 -73.17
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    Pooled placebo v SLN360 450 mg Q24W
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -88.43
         upper limit
    		 -77.49
    Variability estimate
    Standard error of the mean

    Secondary: Time-averaged percent change in lipoprotein(a) molar concentration from baseline to Week 60

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    End point title
    		 Time-averaged percent change in lipoprotein(a) molar concentration from baseline to Week 60
    End point description
    Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Week 60 relative to baseline
    End point values
    		 SLN360 300 mg Q16W SLN360 300 mg Q24W SLN360 450 mg Q24W Pooled placebo
    Number of subjects analysed
    42
    44
    45
    47
    Units: Percentage
        least squares mean (standard error)
    -78.0 ( 2.24 )
    -70.7 ( 2.19 )
    -76.0 ( 2.16 )
    1.1 ( 2.11 )
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    SLN360 300 mg Q16W v Pooled placebo
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -79.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -85.25
         upper limit
    		 -73.1
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    SLN360 300 mg Q24W v Pooled placebo
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -71.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -77.81
         upper limit
    		 -65.8
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    SLN360 450 mg Q24W v Pooled placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -77.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -83.09
         upper limit
    		 -71.15
    Variability estimate
    Standard error of the mean

    Secondary: Time-averaged percent change in apolipoprotein(B) concentration from baseline to Week 36

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    End point title
    		 Time-averaged percent change in apolipoprotein(B) concentration from baseline to Week 36
    End point description
    Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Week 36 relative to baseline
    End point values
    		 SLN360 300 mg Q16W SLN360 300 mg Q24W SLN360 450 mg Q24W Pooled placebo
    Number of subjects analysed
    42
    44
    45
    47
    Units: Percentage
        least squares mean (standard error)
    -16.9 ( 1.93 )
    -13.5 ( 1.88 )
    -18.6 ( 1.86 )
    -3.6 ( 1.82 )
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    Pooled placebo v SLN360 300 mg Q16W
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -13.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.55
         upper limit
    		 -8.09
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    SLN360 300 mg Q24W v Pooled placebo
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0002
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -9.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.02
         upper limit
    		 -4.68
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    SLN360 450 mg Q24W v Pooled placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.1
         upper limit
    		 -9.82
    Variability estimate
    Standard error of the mean

    Secondary: Time-averaged percent change in apolipoprotein(B) concentration from baseline to Week 48

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    End point title
    		 Time-averaged percent change in apolipoprotein(B) concentration from baseline to Week 48
    End point description
    Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Week 48 relative to baseline
    End point values
    		 SLN360 300 mg Q16W SLN360 300 mg Q24W SLN360 450 mg Q24W Pooled placebo
    Number of subjects analysed
    42
    44
    45
    47
    Units: Percentage
        least squares mean (standard error)
    -16.4 ( 1.94 )
    -12.6 ( 1.90 )
    -18.0 ( 1.88 )
    -4.0 ( 1.83 )
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    SLN360 300 mg Q16W v Pooled placebo
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -12.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.62
         upper limit
    		 -7.08
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    SLN360 300 mg Q24W v Pooled placebo
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0013
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -8.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.85
         upper limit
    		 -3.44
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    SLN360 450 mg Q24W v Pooled placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.2
         upper limit
    		 -8.84
    Variability estimate
    Standard error of the mean

    Secondary: Time-averaged percent change in apolipoprotein(B) concentration from baseline to Week 60

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    End point title
    		 Time-averaged percent change in apolipoprotein(B) concentration from baseline to Week 60
    End point description
    Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Week 60 relative to baseline
    End point values
    		 SLN360 300 mg Q16W SLN360 300 mg Q24W SLN360 450 mg Q24W Pooled placebo
    Number of subjects analysed
    42
    44
    45
    47
    Units: Percentage
        least squares mean (standard error)
    -15.0 ( 2.04 )
    -10.9 ( 1.99 )
    -16.4 ( 1.97 )
    -3.8 ( 1.93 )
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    SLN360 300 mg Q16W v Pooled placebo
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -11.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.81
         upper limit
    		 -5.73
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    SLN360 300 mg Q24W v Pooled placebo
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0106
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.64
         upper limit
    		 -1.69
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    SLN360 450 mg Q24W v Pooled placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -12.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.04
         upper limit
    		 -7.15
    Variability estimate
    Standard error of the mean

    Secondary: Time-averaged percent change in low-density lipoprotein cholesterol concentration from baseline to Week 36

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    End point title
    		 Time-averaged percent change in low-density lipoprotein cholesterol concentration from baseline to Week 36
    End point description
    Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Week 36 relative to baseline
    End point values
    		 SLN360 300 mg Q16W SLN360 300 mg Q24W SLN360 450 mg Q24W Pooled placebo
    Number of subjects analysed
    42
    44
    45
    47
    Units: Percentage
        least squares mean (standard error)
    -22.3 ( 8.16 )
    -20.1 ( 7.98 )
    -15.5 ( 7.89 )
    9.6 ( 7.72 )
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    SLN360 300 mg Q16W v Pooled placebo
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0051
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -31.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -54.07
         upper limit
    		 -9.72
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    SLN360 300 mg Q24W v Pooled placebo
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0081
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -29.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -51.62
         upper limit
    		 -7.81
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    Pooled placebo v SLN360 450 mg Q24W
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0241
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -25.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -46.89
         upper limit
    		 -3.33
    Variability estimate
    Standard error of the mean

    Secondary: Time-averaged percent change in low-density lipoprotein cholesterol concentration from baseline to Week 48

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    End point title
    		 Time-averaged percent change in low-density lipoprotein cholesterol concentration from baseline to Week 48
    End point description
    Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Week 48 relative to baseline
    End point values
    		 SLN360 300 mg Q16W SLN360 300 mg Q24W SLN360 450 mg Q24W Pooled placebo
    Number of subjects analysed
    42
    44
    45
    47
    Units: Percentage
        least squares mean (standard error)
    -20.9 ( 7.01 )
    -18.5 ( 6.85 )
    -17.0 ( 6.78 )
    8.9 ( 6.63 )
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    SLN360 300 mg Q16W v Pooled placebo
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0023
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -29.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -48.86
         upper limit
    		 -10.76
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    SLN360 300 mg Q24W v Pooled placebo
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0046
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -27.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -46.23
         upper limit
    		 -8.58
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    SLN360 450 mg Q24W v Pooled placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0068
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -44.67
         upper limit
    		 -7.24
    Variability estimate
    Standard error of the mean

    Secondary: Time-averaged percent change in low-density lipoprotein cholesterol concentration from baseline to Week 60

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    End point title
    		 Time-averaged percent change in low-density lipoprotein cholesterol concentration from baseline to Week 60
    End point description
    Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Week 60 relative to baseline
    End point values
    		 SLN360 300 mg Q16W SLN360 300 mg Q24W SLN360 450 mg Q24W Pooled placebo
    Number of subjects analysed
    42
    44
    45
    47
    Units: Percentage
        least squares mean (standard error)
    -19.3 ( 7.45 )
    -16.8 ( 7.28 )
    -14.7 ( 7.19 )
    9.3 ( 7.04 )
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    SLN360 300 mg Q16W v Pooled placebo
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0057
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -28.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -48.91
         upper limit
    		 -8.46
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    SLN360 300 mg Q24W v Pooled placebo
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0106
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -26.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -46.13
         upper limit
    		 -6.16
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Analysis of variance for the secondary endpoint
    Comparison groups
    SLN360 450 mg Q24W v Pooled placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0179
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -24.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -43.93
         upper limit
    		 -4.2
    Variability estimate
    Standard error of the mean

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to week 60).
    Adverse event reporting additional description
    Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Placebo Q16W
    Reporting group description
    		 Placebo administered subcutaneously at Weeks 0, 16 and 32 (dosing every 16 weeks [Q16W]).

    Reporting group title
    Placebo Q24W
    Reporting group description
    		 Placebo administered subcutaneously at Weeks 0 and 24 (dosing every 24 weeks [Q24W]). This group was stratified so that half of participants were dosed to match the SLN360 300 mg Q24W group and half were dosed to match the SLN360 450 mg Q24W group (with respect to injected volume).

    Reporting group title
    SLN360 300 mg Q16W
    Reporting group description
    		 SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W).

    Reporting group title
    SLN360 300 mg Q24W
    Reporting group description
    		 SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W).

    Reporting group title
    SLN360 450 mg Q24W
    Reporting group description
    		 SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W).

    Serious adverse events
    		 Placebo Q16W Placebo Q24W SLN360 300 mg Q16W SLN360 300 mg Q24W SLN360 450 mg Q24W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 23 (4.35%)
    3 / 24 (12.50%)
    6 / 42 (14.29%)
    2 / 44 (4.55%)
    5 / 45 (11.11%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 42 (2.38%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant polyp (rectal)
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    0 / 42 (0.00%)
    0 / 44 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 42 (2.38%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    0 / 42 (0.00%)
    1 / 44 (2.27%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    0 / 42 (0.00%)
    0 / 44 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 24 (0.00%)
    0 / 42 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Acute vestibular syndrome
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    0 / 42 (0.00%)
    0 / 44 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 24 (4.17%)
    0 / 42 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 42 (2.38%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    0 / 42 (0.00%)
    1 / 44 (2.27%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 42 (2.38%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 42 (2.38%)
    0 / 44 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 42 (2.38%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polymyositis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 42 (2.38%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Lymph node tuberculosis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 42 (2.38%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    0 / 42 (0.00%)
    0 / 44 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 24 (4.17%)
    0 / 42 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 24 (4.17%)
    0 / 42 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Q16W Placebo Q24W SLN360 300 mg Q16W SLN360 300 mg Q24W SLN360 450 mg Q24W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 23 (78.26%)
    22 / 24 (91.67%)
    42 / 42 (100.00%)
    43 / 44 (97.73%)
    42 / 45 (93.33%)
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 24 (0.00%)
    4 / 42 (9.52%)
    1 / 44 (2.27%)
    2 / 45 (4.44%)
         occurrences all number
    2
    0
    8
    1
    4
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 24 (0.00%)
    0 / 42 (0.00%)
    1 / 44 (2.27%)
    2 / 45 (4.44%)
         occurrences all number
    2
    0
    0
    1
    2
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    2 / 23 (8.70%)
    3 / 24 (12.50%)
    1 / 42 (2.38%)
    1 / 44 (2.27%)
    2 / 45 (4.44%)
         occurrences all number
    2
    3
    1
    2
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 24 (4.17%)
    3 / 42 (7.14%)
    4 / 44 (9.09%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    3
    5
    1
    Headache
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 24 (4.17%)
    5 / 42 (11.90%)
    3 / 44 (6.82%)
    6 / 45 (13.33%)
         occurrences all number
    1
    1
    5
    5
    8
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 24 (4.17%)
    0 / 42 (0.00%)
    4 / 44 (9.09%)
    1 / 45 (2.22%)
         occurrences all number
    2
    1
    0
    4
    1
    Influenza-like illness
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 24 (4.17%)
    2 / 42 (4.76%)
    1 / 44 (2.27%)
    7 / 45 (15.56%)
         occurrences all number
    0
    1
    2
    1
    7
    Injection site reaction
         subjects affected / exposed
    2 / 23 (8.70%)
    2 / 24 (8.33%)
    35 / 42 (83.33%)
    36 / 44 (81.82%)
    37 / 45 (82.22%)
         occurrences all number
    3
    2
    71
    55
    109
    Malaise
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 24 (4.17%)
    6 / 42 (14.29%)
    0 / 44 (0.00%)
    4 / 45 (8.89%)
         occurrences all number
    0
    1
    8
    0
    5
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 24 (4.17%)
    0 / 42 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 24 (8.33%)
    0 / 42 (0.00%)
    0 / 44 (0.00%)
    2 / 45 (4.44%)
         occurrences all number
    1
    3
    0
    0
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 24 (8.33%)
    1 / 42 (2.38%)
    1 / 44 (2.27%)
    1 / 45 (2.22%)
         occurrences all number
    1
    2
    2
    1
    1
    Haemorrhoids
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 24 (0.00%)
    0 / 42 (0.00%)
    0 / 44 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    2
    0
    0
    0
    1
    Nausea
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 24 (8.33%)
    1 / 42 (2.38%)
    1 / 44 (2.27%)
    1 / 45 (2.22%)
         occurrences all number
    2
    2
    1
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 24 (8.33%)
    0 / 42 (0.00%)
    2 / 44 (4.55%)
    0 / 45 (0.00%)
         occurrences all number
    0
    2
    0
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 24 (0.00%)
    3 / 42 (7.14%)
    4 / 44 (9.09%)
    2 / 45 (4.44%)
         occurrences all number
    2
    0
    4
    4
    2
    Back pain
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 24 (0.00%)
    2 / 42 (4.76%)
    2 / 44 (4.55%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    2
    2
    0
    Myalgia
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 24 (4.17%)
    1 / 42 (2.38%)
    1 / 44 (2.27%)
    7 / 45 (15.56%)
         occurrences all number
    1
    1
    2
    1
    8
    Osteoarthritis
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 24 (8.33%)
    1 / 42 (2.38%)
    1 / 44 (2.27%)
    0 / 45 (0.00%)
         occurrences all number
    0
    2
    1
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    2 / 42 (4.76%)
    1 / 44 (2.27%)
    3 / 45 (6.67%)
         occurrences all number
    0
    0
    2
    1
    3
    Infections and infestations
    COVID-19
         subjects affected / exposed
    3 / 23 (13.04%)
    4 / 24 (16.67%)
    2 / 42 (4.76%)
    6 / 44 (13.64%)
    4 / 45 (8.89%)
         occurrences all number
    3
    4
    2
    7
    4
    Nasopharyngitis
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 24 (0.00%)
    3 / 42 (7.14%)
    6 / 44 (13.64%)
    6 / 45 (13.33%)
         occurrences all number
    2
    0
    3
    8
    9
    Rhinitis
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 24 (0.00%)
    0 / 42 (0.00%)
    0 / 44 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    2
    0
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 23 (4.35%)
    3 / 24 (12.50%)
    6 / 42 (14.29%)
    7 / 44 (15.91%)
    5 / 45 (11.11%)
         occurrences all number
    1
    6
    7
    8
    5
    Urinary tract infection
         subjects affected / exposed
    3 / 23 (13.04%)
    0 / 24 (0.00%)
    5 / 42 (11.90%)
    1 / 44 (2.27%)
    3 / 45 (6.67%)
         occurrences all number
    4
    0
    6
    2
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/39556769
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    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.

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