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    Clinical Trial Results:
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Crossover Study to Evaluate the Efficacy and Safety of LY3454738 in Adults with Chronic Spontaneous Urticaria Inadequately Controlled with H1-Antihistamines

    Summary
    EudraCT number
    		 2019-002495-13
    Trial protocol
    		 DE  
    Global end of trial date
    24 Feb 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Mar 2022
    First version publication date
    02 Mar 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    J1B-MC-FRCF
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04159701
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 17480
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    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 Feb 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Feb 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The reason for this study is to see if the study drug LY3454738 is safe and effective as treatment for participants with hives that are caused by chronic spontaneous urticaria (CSU) and that are not controlled with H1-antihistamines.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Nov 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 43
    Country: Number of subjects enrolled
    Poland: 6
    Country: Number of subjects enrolled
    Germany: 3
    Worldwide total number of subjects
    52
    EEA total number of subjects
    9
    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)
    51
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 No Text Available

    Pre-assignment
    Screening details
    		 No Text Available

    Period 1
    Period 1 title
    Period 1: Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence Group 1: (500 mg LY3454738, Placebo)
    Arm description
    		 Participants received 500 mg LY3454738 intravenously (IV) every 2 weeks (Q2W) for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY3454738
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered IV.

    Arm title
    		 Sequence Group 2: (Placebo, 500 mg LY3454738)
    Arm description
    		 Participants received Placebo IV Q2W for 12 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered IV.

    Number of subjects in period 1
    		Sequence Group 1: (500 mg LY3454738, Placebo) Sequence Group 2: (Placebo, 500 mg LY3454738)
    Started
    39
    13
    Received at least one dose of study drug
    39
    13
    Completed
    31
    12
    Not completed
    8
    1
         Study Terminated by sponsor
    4
    1
         Consent withdrawn by subject
    3
    -
         Pregnancy
    1
    -
    Period 2
    Period 2 title
    Washout Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence Group 1: (500 mg LY3454738, Placebo)
    Arm description
    		 Participants did not receive study drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Sequence Group 2: (Placebo, 500 mg LY3454738)
    Arm description
    		 Participants did not receive study drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Sequence Group 1: (500 mg LY3454738, Placebo) Sequence Group 2: (Placebo, 500 mg LY3454738)
    Started
    31
    12
    Completed
    18
    8
    Not completed
    13
    4
         Study Terminated by sponsor
    10
    3
         Consent withdrawn by subject
    1
    -
         site terminated by sponsor
    -
    1
         Miscellaneous
    1
    -
         Inadvertent Enrollment
    1
    -
    Period 3
    Period 3 title
    Period 2: Treatment Period (Crossover)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence Group 1: (500 mg LY3454738, Placebo)
    Arm description
    		 Participants received Placebo IV Q2W for 12 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered IV.

    Arm title
    		 Sequence Group 2: (Placebo, 500 mg LY3454738)
    Arm description
    		 Participants received 500 mg LY3454738 IV Q2W for 12 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    LY3454738
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered IV.

    Number of subjects in period 3
    		Sequence Group 1: (500 mg LY3454738, Placebo) Sequence Group 2: (Placebo, 500 mg LY3454738)
    Started
    18
    8
    Completed
    18
    5
    Not completed
    0
    3
         Study Terminated by sponsor
    -
    2
         Consent withdrawn by subject
    -
    1
    Period 4
    Period 4 title
    Post-treatment follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Sequence Group 1: (500 mg LY3454738, Placebo)
    Arm description
    		 Participants did not receive study drug during the follow-up period.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Sequence Group 2: (Placebo, 500 mg LY3454738)
    Arm description
    		 Participants did not receive study drug during the follow-up period.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 4
    		Sequence Group 1: (500 mg LY3454738, Placebo) Sequence Group 2: (Placebo, 500 mg LY3454738)
    Started
    29
    9
    Completed
    19
    6
    Not completed
    10
    3
         Study Terminated by sponsor
    6
    3
         Consent withdrawn by subject
    3
    -
         Inadvertent Enrollment
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sequence Group 1: (500 mg LY3454738, Placebo)
    Reporting group description
    		 Participants received 500 mg LY3454738 intravenously (IV) every 2 weeks (Q2W) for 12 weeks.

    Reporting group title
    Sequence Group 2: (Placebo, 500 mg LY3454738)
    Reporting group description
    		 Participants received Placebo IV Q2W for 12 weeks.

    Reporting group values
    		 Sequence Group 1: (500 mg LY3454738, Placebo) Sequence Group 2: (Placebo, 500 mg LY3454738) Total
    Number of subjects
    		 39 13 52
    Age categorical
    Units: Subjects
        <=18 years
    		 0 0 0
        Between 18 and 65 years
    		 38 13 51
        >=65 years
    		 1 0 1
    Gender categorical
    Units: Subjects
        Female
    		 30 11 41
        Male
    		 9 2 11
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 2 0 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 4 0 4
        White
    		 33 13 46
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Region of Enrollment
    Units: Subjects
        United States
    		 33 10 43
        Poland
    		 5 1 6
        Germany
    		 1 2 3
    Urticaria Activity Score Over 7 Days (UAS7) Score
    The baseline UAS7 is the sum of the daily UAS over the 7 days prior to the first treatment. A higher UAS or higher UAS7 indicates greater urticaria disease activity.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 26.51 ± 7.48 24.26 ± 5.23 -

    End points

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    End points reporting groups
    Reporting group title
    Sequence Group 1: (500 mg LY3454738, Placebo)
    Reporting group description
    		 Participants received 500 mg LY3454738 intravenously (IV) every 2 weeks (Q2W) for 12 weeks.

    Reporting group title
    Sequence Group 2: (Placebo, 500 mg LY3454738)
    Reporting group description
    		 Participants received Placebo IV Q2W for 12 weeks.
    Reporting group title
    Sequence Group 1: (500 mg LY3454738, Placebo)
    Reporting group description
    		 Participants did not receive study drug.

    Reporting group title
    Sequence Group 2: (Placebo, 500 mg LY3454738)
    Reporting group description
    		 Participants did not receive study drug.
    Reporting group title
    Sequence Group 1: (500 mg LY3454738, Placebo)
    Reporting group description
    		 Participants received Placebo IV Q2W for 12 weeks.

    Reporting group title
    Sequence Group 2: (Placebo, 500 mg LY3454738)
    Reporting group description
    		 Participants received 500 mg LY3454738 IV Q2W for 12 weeks.
    Reporting group title
    Sequence Group 1: (500 mg LY3454738, Placebo)
    Reporting group description
    		 Participants did not receive study drug during the follow-up period.

    Reporting group title
    Sequence Group 2: (Placebo, 500 mg LY3454738)
    Reporting group description
    		 Participants did not receive study drug during the follow-up period.

    Subject analysis set title
    500 mg LY3454738
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received 500 mg LY3454738 intravenously (IV) every 2 weeks (Q2W) for 12 weeks.

    Primary: Mean Change from Baseline in Urticaria Activity Score Over 7 Days (UAS7)

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    End point title
    		 Mean Change from Baseline in Urticaria Activity Score Over 7 Days (UAS7)
    End point description
    The UAS7 is the sum of the daily urticaria activity scores (UAS) over a 7-day period and ranges from 0 to 42. The daily UAS is the sum of the daily itch severity score (ISS) and daily number of hives score, and ranges from 0 to 6. The baseline UAS7 is the sum of the daily UAS over the 7 days prior to the first treatment. A higher UAS or higher UAS7 indicates greater urticaria disease activity. The ANCOVA model includes treatment as a factor and baseline UAS7 score in First 12-Week treatment period as covariates. Missing Week 12 scores will be imputed by carrying forward the participants’ baseline scores (BOCF). Analysis Population Description: All randomized participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Sequence Group 1: (500 mg LY3454738, Placebo) Sequence Group 2: (Placebo, 500 mg LY3454738)
    Number of subjects analysed
    39
    13
    Units: units on a scale
        least squares mean (standard error)
    -6.38 ± 1.645
    -9.32 ± 2.864
    Statistical analysis title
    		 UAS7
    Comparison groups
    Sequence Group 1: (500 mg LY3454738, Placebo) v Sequence Group 2: (Placebo, 500 mg LY3454738)
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.38
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.73
         upper limit
    		 9.6

    Secondary: Mean Change from Baseline in Itch Severity Score Over 7 Days (ISS7)

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    End point title
    		 Mean Change from Baseline in Itch Severity Score Over 7 Days (ISS7)
    End point description
    The ISS7 is the sum of the daily ISS over a 7-day period and ranges from 0 to 21. The daily ISS is the average of the morning and evening ISS on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The baseline ISS7 is the sum of the daily ISS over the 7 days prior to the first treatment. A higher ISS or higher ISS7 indicates more severe itching.The ANCOVA model includes treatment as a factor and baseline UAS7 score in First 12-Week treatment period as covariates. Missing Week 12 scores will be imputed by carrying forward the participants’ baseline scores (BOCF). Analysis Population Description: All randomized participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Sequence Group 1: (500 mg LY3454738, Placebo) Sequence Group 2: (Placebo, 500 mg LY3454738)
    Number of subjects analysed
    39
    13
    Units: units on a scale
        least squares mean (standard error)
    -2.91 ± 0.780
    -4.21 ± 1.367
    Statistical analysis title
    		 ISS7
    Comparison groups
    Sequence Group 1: (500 mg LY3454738, Placebo) v Sequence Group 2: (Placebo, 500 mg LY3454738)
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.415
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.89
         upper limit
    		 4.5

    Secondary: Mean Change from Baseline in Hives Severity Score Over 7 Days (HSS7)

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    End point title
    		 Mean Change from Baseline in Hives Severity Score Over 7 Days (HSS7)
    End point description
    The HSS7 is the sum of the daily number of hives over a 7-day period and ranges from 0 to 21. The daily number of hives score (also called HSS) is the average of the morning and evening number of hive scores on a four-point scale of 0 (none), 1 (between 1 and 6 hives, inclusive), 2 (between 7 and 12 hives, inclusive), and 3 (greater than 12 hives). The baseline weekly HSS7 is the sum of the HSS over the 7 days prior to the first treatment. A higher HSS or higher HSS7 indicates a greater number of hives. The ANCOVA model includes treatment as a factor and baseline UAS7 score in First 12-Week treatment period as covariates. Missing Week 12 scores will be imputed by carrying forward the participants' baseline scores (BOCF). Analysis Population Description: All randomized participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Sequence Group 1: (500 mg LY3454738, Placebo) Sequence Group 2: (Placebo, 500 mg LY3454738)
    Number of subjects analysed
    39
    13
    Units: units on a scale
        least squares mean (standard error)
    -3.45 ± 0.931
    -5.17 ± 1.631
    Statistical analysis title
    		 HSS7
    Comparison groups
    Sequence Group 1: (500 mg LY3454738, Placebo) v Sequence Group 2: (Placebo, 500 mg LY3454738)
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.369
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.09
         upper limit
    		 5.53

    Secondary: Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) ≤6 (Stratified by baseline UAS7 (< 28 vs >= 28) score)

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    End point title
    		 Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) ≤6 (Stratified by baseline UAS7 (< 28 vs >= 28) score)
    End point description
    The UAS7 is the sum of the daily urticaria activity scores (UAS) over a 7-day period and ranges from 0 to 42. The daily UAS is the sum of the daily itch severity score (ISS) and daily number of hives score, and ranges from 0 to 6. The baseline UAS7 is the sum of the daily UAS over the 7 days prior to the first treatment. A higher UAS or higher UAS7 indicates greater urticaria disease activity. Analysis Population Description: All randomized participants who received at least one dose of study drug and had UAS7 ≤6.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Sequence Group 1: (500 mg LY3454738, Placebo) Sequence Group 2: (Placebo, 500 mg LY3454738)
    Number of subjects analysed
    39
    13
    Units: percentage of participants
        number (not applicable)
    15.4
    23.1
    Statistical analysis title
    		 UAS7
    Statistical analysis description
    Cochran-Mantel-Haenszel (CMH) test adjusted by baseline UAS7 (< 28 vs >= 28) score.
    Comparison groups
    Sequence Group 1: (500 mg LY3454738, Placebo) v Sequence Group 2: (Placebo, 500 mg LY3454738)
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.674
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.14
         upper limit
    		 2.7

    Secondary: Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) ≤6 (Stratified by baseline UAS7 (< median vs >= median) Score)

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    End point title
    		 Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) ≤6 (Stratified by baseline UAS7 (< median vs >= median) Score)
    End point description
    The UAS7 is the sum of the daily urticaria activity scores (UAS) over a 7-day period and ranges from 0 to 42.The daily UAS is the sum of the daily itch severity score (ISS) and daily number of hives score, and ranges from 0 to 6. The baseline UAS7 is the sum of the daily UAS over the 7 days prior to the first treatment. A higher UAS or higher UAS7 indicates greater urticaria disease activity. Analysis Population Description: All randomized participants who received at least one dose of study drug and had UAS7 ≤6.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Sequence Group 1: (500 mg LY3454738, Placebo) Sequence Group 2: (Placebo, 500 mg LY3454738)
    Number of subjects analysed
    39
    13
    Units: percentage of participants
        number (not applicable)
    15.4
    23.1
    Statistical analysis title
    		 UAS7
    Statistical analysis description
    Cochran-Mantel-Haenszel (CMH) test adjusted by baseline UAS7 (< median vs >= median) score.
    Comparison groups
    Sequence Group 1: (500 mg LY3454738, Placebo) v Sequence Group 2: (Placebo, 500 mg LY3454738)
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.674
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.13
         upper limit
    		 2.68

    Secondary: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 336 Hours (AUC [0-336h]) of LY3454738

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    End point title
    		 Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 336 Hours (AUC [0-336h]) of LY3454738
    End point description
    Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 336 Hours (AUC [0-336h]) of LY3454738 Analysis Population Description: All randomized participants who received at least one dose of LY3454738 and had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Before Infusion, after infusion, 1 hour after infusion and 2 hours after infusion on Day 1; Before Infusion on Day 8, 15, 29, 43, 57, 71, 85, 92, 99, 113, 127, 141, 155, 169 and Post-Treatment Follow-up
    End point values
    		 500 mg LY3454738
    Number of subjects analysed
    44
    Units: micrograms*hour per milliliter( ug*h/mL)
        geometric mean (geometric coefficient of variation)
    53400 ± 49
    No statistical analyses for this end point

    Secondary: PK: Maximum Concentration (Cmax) of LY3454738

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    End point title
    		 PK: Maximum Concentration (Cmax) of LY3454738
    End point description
    PK: Maximum Concentration (Cmax) of LY3454738 Analysis Population Description: All randomized participants who received at least one dose of LY3454738 and had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Before Infusion, after infusion, 1 hour after infusion and 2 hours after infusion on Day 1; Before Infusion on Day 8, 15, 29, 43, 57, 71, 85, 92, 99, 113, 127, 141, 155, 169 and Post-Treatment Follow-up
    End point values
    		 500 mg LY3454738
    Number of subjects analysed
    44
    Units: micrograms per milliliter (ug/mL)
        geometric mean (geometric coefficient of variation)
    256 ± 30.8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline Up To 28 Weeks
    Adverse event reporting additional description
    All participants who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    500 mg LY3454738_First 12-Week Period
    Reporting group description
    		 Participants received 500 mg LY3454738 IV Q2W for 12 weeks.

    Reporting group title
    Placebo_First 12-Week Period
    Reporting group description
    		 Participants received Placebo IV Q2W for 12 weeks.

    Reporting group title
    500 LY3454738_Second 12-Week Crossover Period
    Reporting group description
    		 Participants received 500 mg LY3454738 IV Q2W for 12 weeks.

    Reporting group title
    Placebo_Second 12-Week Crossover Period
    Reporting group description
    		 Participants received Placebo IV Q2W for 12 weeks.

    Reporting group title
    Follow-Up Period
    Reporting group description
    		 Participants did not receive study drug during the follow-up period.

    Serious adverse events
    		 500 mg LY3454738_First 12-Week Period Placebo_First 12-Week Period 500 LY3454738_Second 12-Week Crossover Period Placebo_Second 12-Week Crossover Period Follow-Up Period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 500 mg LY3454738_First 12-Week Period Placebo_First 12-Week Period 500 LY3454738_Second 12-Week Crossover Period Placebo_Second 12-Week Crossover Period Follow-Up Period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 39 (10.26%)
    4 / 13 (30.77%)
    1 / 8 (12.50%)
    7 / 18 (38.89%)
    2 / 38 (5.26%)
    Investigations
    blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    haematocrit decreased
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    haemoglobin decreased
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    headache
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    3 / 18 (16.67%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    0
    3
    0
    hypoaesthesia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    migraine
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    General disorders and administration site conditions
    fatigue
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    sensation of foreign body
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Eye disorders
    eczema eyelids
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Gastrointestinal disorders
    abdominal pain upper
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    2 / 18 (11.11%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    dyspepsia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    dysphagia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    nausea
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    2 / 18 (11.11%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Psychiatric disorders
    bipolar disorder
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    pain in extremity
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Infections and infestations
    covid-19
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    2 / 38 (5.26%)
         occurrences all number
    0
    0
    0
    1
    2
    otitis media
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    post procedural infection
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    urinary tract infection
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    viral upper respiratory tract infection
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Metabolism and nutrition disorders
    metabolic acidosis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Jun 2020
    Changes to inclusion and exclusion (I/E) and criteria for withholding and discontinuing treatment were made to minimize risks of enrolling or dosing patients with COVID-19.

    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.
    The study was terminated for lack of efficacy after an interim analysis was performed.
    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.

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