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    Clinical Trial Results:
    A Randomized Double-Blind Placebo-Controlled Study of the LEPR Agonist Antibody REGN4461 for the Treatment of Metabolic Abnormalities in Patients with Familial Partial Lipodystrophy

    Summary
    EudraCT number
    		 2021-000138-33
    Trial protocol
    		 ES   FR  
    Global end of trial date
    18 Apr 2024

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    R4461-PLD-20100
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05088460
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Regeneron Pharmaceuticals, Inc.
    Sponsor organisation address
    777 Old Saw Mill River Rd, Tarrytown, United States, 10591
    Public contact
    Clinical Trials Administrator, Regeneron Pharmaceuticals, Inc., 001 8447346643, clinicaltrials@regeneron.com
    Scientific contact
    Clinical Trials Administrator, Regeneron Pharmaceuticals, Inc., 001 8447346643, clinicaltrials@regeneron.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
    18 Apr 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Apr 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Two cohorts were studied based on leptin levels. Cohort A was composed of participants with baseline leptin <8.0 ng/mL & Cohort B was composed of participants with baseline leptin 8.0 to ≤20.0 ng/mL. The primary objectives evaluated participants in Cohort A only: • effect of REGN4461 on fasting triglycerides (TG) in participants with elevated baseline fasting TG • effect of REGN4461 on hyperglycemia in participants with elevated baseline Hemoglobin A1c (HbA1c) Secondary objectives evaluated: Cohort B & the combined set of Cohorts A plus B: • effect of REGN4461 on fasting TG levels in participants with hypertriglyceridemia • effect of REGN4461 on glycemic control in participants with hyperglycemia Cohorts A & B separately, & the combined set of Cohorts A plus B: • effect of REGN4461 on liver fat in participants with hepatic steatosis • effect of REGN4461 on hunger • safety & tolerability of REGN4461 • concentration profile of REGN4461 over time • immunogenicity
    Protection of trial subjects
    It is the responsibility of both the sponsor and the investigator(s) to ensure that this clinical study is conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with the ICH guidelines for GCP and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Feb 2022
    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
    Türkiye: 4
    Country: Number of subjects enrolled
    United States: 16
    Worldwide total number of subjects
    20
    EEA total number of subjects
    0
    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)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 66 participants were screened, of whom 20 were randomized and received study treatment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor
    Blinding implementation details
    Double-blind treatment for 12 weeks followed by 12 weeks of single-blind treatment

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm 1 Cohort A: Placebo to REGN4461
    Arm description
    		 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
    Arm type
    		 Placebo

    Investigational medicinal product name
    mibavademab
    Investigational medicinal product code
    REGN4461
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    REGN4461 for 12 weeks during SBTP

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Matching Placebo for 12 weeks during DBTP

    Arm title
    		 Arm 2 Cohort A: REGN4461 to REGN4461
    Arm description
    		 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mibavademab
    Investigational medicinal product code
    REGN4461
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    REGN4461 for 24 weeks

    Arm title
    		 Arm 1 Cohort B: Placebo to REGN4461
    Arm description
    		 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mibavademab
    Investigational medicinal product code
    REGN4461
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    REGN4461 for 12 weeks during SBTP

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Matching Placebo for 12 weeks during DBTP

    Arm title
    		 Arm 2 Cohort B: REGN4461 to REGN4461
    Arm description
    		 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mibavademab
    Investigational medicinal product code
    REGN4461
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    REGN4461 for 24 weeks

    Number of subjects in period 1
    		Arm 1 Cohort A: Placebo to REGN4461 Arm 2 Cohort A: REGN4461 to REGN4461 Arm 1 Cohort B: Placebo to REGN4461 Arm 2 Cohort B: REGN4461 to REGN4461
    Started
    6
    6
    4
    4
    Completed treatment during DBTP
    5 [1]
    6
    4
    4
    Completed treatment during SBTP
    5 [2]
    5 [3]
    3 [4]
    4
    Completed
    6
    6
    4
    4
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 1 participant completed the DBTP but was prematurely discontinued before entering the SBTP at the request of the sponsor due to the early study termination.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 1 participant prematurely discontinued study treatment before completing SBTP at the request of the sponsor due to the early study termination.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 1 participant prematurely discontinued before completing the DBTP at the request of the sponsor due to the early study termination.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 1 participant prematurely discontinued before completing the DBTP at the request of the sponsor due to the early study termination.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm 1 Cohort A: Placebo to REGN4461
    Reporting group description
    		 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.

    Reporting group title
    Arm 2 Cohort A: REGN4461 to REGN4461
    Reporting group description
    		 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.

    Reporting group title
    Arm 1 Cohort B: Placebo to REGN4461
    Reporting group description
    		 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.

    Reporting group title
    Arm 2 Cohort B: REGN4461 to REGN4461
    Reporting group description
    		 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.

    Reporting group values
    		 Arm 1 Cohort A: Placebo to REGN4461 Arm 2 Cohort A: REGN4461 to REGN4461 Arm 1 Cohort B: Placebo to REGN4461 Arm 2 Cohort B: REGN4461 to REGN4461 Total
    Number of subjects
    		 6 6 4 4 20
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 6 6 4 4 20
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.5 ( 16.79 ) 43.8 ( 13.47 ) 48.0 ( 11.97 ) 40.3 ( 12.82 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 5 6 3 4 18
        Male
    		 1 0 1 0 2
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 0 0 0 1 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 0 0 0 0 0
        White
    		 6 6 3 3 18
        More than one race
    		 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 1 0 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 0 0
        Not Hispanic or Latino
    		 6 6 4 4 20
        Unknown or Not Reported
    		 0 0 0 0 0
    Fasting Triglycerides Serum Concentration
    Units: milligrams per deciliter (mg/dL)
        geometric mean (full range (min-max))
    		 1100.9 (405 to 5681) 737.8 (308 to 2487) 675.0 (426 to 1534) 336.2 (150 to 1376) -
    Hemoglobin A1c (HbA1c)
    Units: Percentage (%)
        arithmetic mean (standard deviation)
    		 8.8 ( 1.62 ) 8.2 ( 1.76 ) 6.9 ( 0.91 ) 8.6 ( 2.06 ) -

    End points

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    End points reporting groups
    Reporting group title
    Arm 1 Cohort A: Placebo to REGN4461
    Reporting group description
    		 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.

    Reporting group title
    Arm 2 Cohort A: REGN4461 to REGN4461
    Reporting group description
    		 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.

    Reporting group title
    Arm 1 Cohort B: Placebo to REGN4461
    Reporting group description
    		 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.

    Reporting group title
    Arm 2 Cohort B: REGN4461 to REGN4461
    Reporting group description
    		 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.

    Subject analysis set title
    Arm 1 Combined Cohort A + B: Placebo to REGN4461
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    "Arm 1 Cohort A" and "Arm 1 Cohort B" combined

    Subject analysis set title
    Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    "Arm 2 Cohort A" and "Arm 2 Cohort B" combined

    Subject analysis set title
    DBTP Arm 1 Cohort A: Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP.

    Subject analysis set title
    DBTP Arm 2 Cohort A: REGN4461
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP.

    Subject analysis set title
    DBTP Arm 1 Cohort B: Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP.

    Subject analysis set title
    DBTP Arm 2 Cohort B: REGN4461
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP.

    Subject analysis set title
    DBTP Arm 1 Combined Cohort A + B: Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    DBTP "Arm 1 Cohort A" and "Arm 1 Cohort B" combined

    Subject analysis set title
    DBTP Arm 2 Combined Cohort A + B: REGN4461
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    DBTP "Arm 2 Cohort A" and "Arm 2 Cohort B" combined

    Subject analysis set title
    SBTP Arm 1 Cohort A: Placebo to REGN4461
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.

    Subject analysis set title
    SBTP Arm 2 Cohort A: REGN4461 to REGN4461
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.

    Subject analysis set title
    SBTP Arm 1 Cohort B: Placebo to REGN4461
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.

    Subject analysis set title
    SBTP Arm 2 Cohort B: REGN4461 to REGN4461
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.

    Subject analysis set title
    SBTP Arm 1 Combined Cohort A + B: Placebo to REGN4461
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    SBTP "Arm 1 Cohort A" and "Arm 1 Cohort B" combined

    Subject analysis set title
    SBTP Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    SBTP "Arm 2 Cohort A" and "Arm 2 Cohort B" combined

    Subject analysis set title
    Arm 1 Cohort A: Placebo to REGN4461
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subgroup of Participants with Screening HbA1C>7%

    Subject analysis set title
    Arm 2 Cohort A: REGN4461 to REGN4461
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subgroup of Participants with Screening HbA1C>7%

    Subject analysis set title
    Arm 1 Cohort B: Placebo to REGN4461
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subgroup of Participants with Screening HbA1C>7%

    Subject analysis set title
    Arm 2 Cohort B: REGN4461 to REGN4461
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subgroup of Participants with Screening HbA1C>7%

    Subject analysis set title
    Arm 1 Combined Cohort A + B: Placebo to REGN4461
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subgroup of Participants with Screening HbA1C>7%

    Subject analysis set title
    Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subgroup of Participants with Screening HbA1C>7%

    Primary: Percent change from baseline to week 12 in fasting serum triglyceride (TG) (Cohort A)

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    End point title
    		 Percent change from baseline to week 12 in fasting serum triglyceride (TG) (Cohort A) [1] [2]
    End point description
    Percentage change in fasting serum TG was reported for participants with elevated baseline fasting TG (> 200 mg/dL) and with baseline leptin < 8.0 ng/mL (Cohort A). Full Analysis Set (FAS): All randomized participants who received any study drug in the double-blind treatment period (DBTP) and had at least 1 post-baseline assessment.
    End point type
    Primary
    End point timeframe
    Baseline to week 12
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics were planned for this endpoint.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Arms reported per protocol.
    End point values
    		 Arm 1 Cohort A: Placebo to REGN4461 Arm 2 Cohort A: REGN4461 to REGN4461
    Number of subjects analysed
    5
    6
    Units: percentage
        arithmetic mean (standard deviation)
    -11.30 ( 46.306 )
    -38.97 ( 16.998 )
    No statistical analyses for this end point

    Primary: Change from baseline to week 12 in hemoglobin A1c (HbA1c) (Cohort A)

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    End point title
    		 Change from baseline to week 12 in hemoglobin A1c (HbA1c) (Cohort A) [3]
    End point description
    Change in HbA1c was reported for participants with elevated baseline HbA1c (> 7.0%) and with baseline leptin < 8.0 ng/mL (Cohort A). FAS: All randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment.
    End point type
    Primary
    End point timeframe
    Baseline to week 12
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics were planned for this endpoint.
    End point values
    		 Arm 1 Cohort A: Placebo to REGN4461 Arm 2 Cohort A: REGN4461 to REGN4461
    Number of subjects analysed
    4
    5
    Units: percentage of glycated hemoglobin
        arithmetic mean (standard deviation)
    -0.05 ( 0.451 )
    -1.08 ( 1.108 )
    No statistical analyses for this end point

    Secondary: Percent change from baseline to week 12 in fasting serum TG (Cohorts B and A + B)

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    End point title
    		 Percent change from baseline to week 12 in fasting serum TG (Cohorts B and A + B) [4]
    End point description
    Percent change in fasting serum TG was reported for participants with elevated baseline fasting TG (>200 mg/dL) in Cohort B and Cohorts A + B. FAS: All randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment.
    End point type
    Secondary
    End point timeframe
    Baseline to week 12
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Arms reported per protocol.
    End point values
    		 Arm 1 Cohort B: Placebo to REGN4461 Arm 2 Cohort B: REGN4461 to REGN4461 Arm 1 Combined Cohort A + B: Placebo to REGN4461 Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
    Number of subjects analysed
    4
    4
    9
    10
    Units: percentage
        arithmetic mean (standard deviation)
    36.78 ( 44.863 )
    -35.59 ( 8.754 )
    10.07 ( 49.689 )
    -37.62 ( 13.752 )
    No statistical analyses for this end point

    Secondary: Percent change from baseline to weeks 12 and 24 in fasting serum TG (Study Arm 1)

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    End point title
    		 Percent change from baseline to weeks 12 and 24 in fasting serum TG (Study Arm 1) [5]
    End point description
    Percent change in fasting serum TG was reported for participants in Study Arm 1. FAS: All randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, Week 24
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Arms reported per protocol.
    End point values
    		 Arm 1 Cohort A: Placebo to REGN4461 Arm 1 Cohort B: Placebo to REGN4461 Arm 1 Combined Cohort A + B: Placebo to REGN4461
    Number of subjects analysed
    5
    4
    9
    Units: percentage
    arithmetic mean (standard deviation)
        Week 12 (n=5, 4, 9)
    -11.30 ( 46.306 )
    36.78 ( 44.863 )
    10.07 ( 49.689 )
        Week 24 (n=5, 2, 7)
    -29.79 ( 35.109 )
    -8.96 ( 13.673 )
    -23.84 ( 30.923 )
    No statistical analyses for this end point

    Secondary: Change from baseline to week 12 in HbA1c (Cohorts B and A + B)

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    End point title
    		 Change from baseline to week 12 in HbA1c (Cohorts B and A + B)
    End point description
    Change in HbA1c was reported for participants with elevated baseline HbA1c (>7.0%) in Cohort B and Cohorts A + B. FAS: All randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment.
    End point type
    Secondary
    End point timeframe
    Baseline to week 12
    End point values
    		 Arm 1 Cohort B: Placebo to REGN4461 Arm 2 Cohort B: REGN4461 to REGN4461 Arm 1 Combined Cohort A + B: Placebo to REGN4461 Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
    Number of subjects analysed
    2
    3
    6
    8
    Units: percentage of glycated hemoglobin
        arithmetic mean (standard deviation)
    -0.20 ( 0.283 )
    -0.90 ( 0.964 )
    -0.10 ( 0.379 )
    -1.01 ( 0.988 )
    No statistical analyses for this end point

    Secondary: Percent change from baseline to weeks 12 and 24 in fasting serum TG (Study Arm 2)

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    End point title
    		 Percent change from baseline to weeks 12 and 24 in fasting serum TG (Study Arm 2) [6]
    End point description
    Percent change in fasting serum TG was reported for participants in Study Arm 2. FAS: All randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, Week 24
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Arms reported per protocol.
    End point values
    		 Arm 2 Cohort A: REGN4461 to REGN4461 Arm 2 Cohort B: REGN4461 to REGN4461 Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
    Number of subjects analysed
    6
    4
    10
    Units: percentage
    arithmetic mean (standard deviation)
        Week 12 (n=6, 4, 10)
    -38.97 ( 16.998 )
    -35.59 ( 8.754 )
    -37.62 ( 13.752 )
        Week 24 (n=4, 4, 8)
    -30.77 ( 48.883 )
    -5.30 ( 51.158 )
    -18.04 ( 48.282 )
    No statistical analyses for this end point

    Secondary: Change from baseline to weeks 12 and 24 in HbA1c (Study Arm 1)

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    End point title
    		 Change from baseline to weeks 12 and 24 in HbA1c (Study Arm 1) [7]
    End point description
    Change from baseline in HbA1c was reported for participants in Study Arm 1. FAS: All randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, Week 24
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Arms reported per protocol.
    End point values
    		 Arm 1 Cohort A: Placebo to REGN4461 Arm 1 Cohort B: Placebo to REGN4461 Arm 1 Combined Cohort A + B: Placebo to REGN4461
    Number of subjects analysed
    5
    4
    9
    Units: percentage of glycated hemoglobin
    arithmetic mean (standard deviation)
        Week 12 (n=5, 4, 9)
    -0.10 ( 0.406 )
    0.13 ( 0.427 )
    0.00 ( 0.406 )
        Week 24 (n=5, 3, 8)
    -0.78 ( 0.694 )
    0.13 ( 0.802 )
    -0.44 ( 0.826 )
    No statistical analyses for this end point

    Secondary: Change from baseline to weeks 12 and 24 in HbA1c (Study Arm 2)

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    End point title
    		 Change from baseline to weeks 12 and 24 in HbA1c (Study Arm 2) [8]
    End point description
    Change from baseline in HbA1c was reported for participants in Study Arm 2. FAS: All randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, Week 24
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Arms reported per protocol.
    End point values
    		 Arm 2 Cohort A: REGN4461 to REGN4461 Arm 2 Cohort B: REGN4461 to REGN4461 Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
    Number of subjects analysed
    6
    4
    10
    Units: percentage of glycated hemoglobin
    arithmetic mean (standard deviation)
        Week 12 (n=6, 4, 10)
    -0.92 ( 1.068 )
    -0.78 ( 0.826 )
    -0.86 ( 0.931 )
        Week 24 (n=5, 4, 9)
    -0.98 ( 1.357 )
    -0.50 ( 1.068 )
    -0.77 ( 1.188 )
    No statistical analyses for this end point

    Secondary: Change from baseline to weeks 12 and 24 in fasting glucose (Study Arm 1)

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    End point title
    		 Change from baseline to weeks 12 and 24 in fasting glucose (Study Arm 1) [9]
    End point description
    Change from baseline in fasting glucose was reported for participants in Study Arm 1. FAS: All randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, Week 24
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Arms reported per protocol.
    End point values
    		 Arm 1 Cohort A: Placebo to REGN4461 Arm 1 Cohort B: Placebo to REGN4461 Arm 1 Combined Cohort A + B: Placebo to REGN4461
    Number of subjects analysed
    5
    4
    9
    Units: milligrams per deciliter (mg/dL)
    arithmetic mean (standard deviation)
        Week 12 (n=5, 4, 9)
    4.8 ( 29.55 )
    0.0 ( 60.37 )
    2.7 ( 42.54 )
        Week 24 (n=5, 2, 7)
    7.2 ( 29.65 )
    -15.5 ( 6.36 )
    0.7 ( 26.75 )
    No statistical analyses for this end point

    Secondary: Change from baseline to weeks 12 and 24 in fasting glucose (Study Arm 2)

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    End point title
    		 Change from baseline to weeks 12 and 24 in fasting glucose (Study Arm 2) [10]
    End point description
    Change from baseline in fasting glucose was reported for participants in Study Arm 2. FAS: All randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, Week 24
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Arms reported per protocol.
    End point values
    		 Arm 2 Cohort A: REGN4461 to REGN4461 Arm 2 Cohort B: REGN4461 to REGN4461 Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
    Number of subjects analysed
    6
    4
    10
    Units: mg/dL
    arithmetic mean (standard deviation)
        Week 12 (n=6, 4, 10)
    -5.2 ( 36.55 )
    -19.5 ( 22.87 )
    -10.9 ( 31.17 )
        Week 24 (n=4, 4, 8)
    1.8 ( 26.35 )
    -12.3 ( 58.59 )
    -5.3 ( 42.71 )
    No statistical analyses for this end point

    Secondary: Percent change from baseline to weeks 12 and 24 in liver fat magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) (Study Arm 1)

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    End point title
    		 Percent change from baseline to weeks 12 and 24 in liver fat magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) (Study Arm 1) [11]
    End point description
    Percent change from baseline in MRI-PDFF was reported for participants with baseline MRI-PDFF ≥8.5% in Study Arm 1. FAS: All randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point. "99999" = SD not calculable with n=1
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, Week 24
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Arms reported per protocol.
    End point values
    		 Arm 1 Cohort A: Placebo to REGN4461 Arm 1 Cohort B: Placebo to REGN4461 Arm 1 Combined Cohort A + B: Placebo to REGN4461
    Number of subjects analysed
    3
    2
    5
    Units: percentage
    arithmetic mean (standard deviation)
        Week 12 (n=3, 2, 5)
    -11.44 ( 18.576 )
    -0.74 ( 9.919 )
    -7.16 ( 15.214 )
        Week 24 (n=2, 1, 3)
    -47.21 ( 22.176 )
    44.81 ( 99999 )
    -16.54 ( 55.394 )
    No statistical analyses for this end point

    Secondary: Percent change from baseline to weeks 12 and 24 in liver fat MRI-PDFF (Study Arm 2)

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    End point title
    		 Percent change from baseline to weeks 12 and 24 in liver fat MRI-PDFF (Study Arm 2) [12]
    End point description
    Percent change from baseline in MRI-PDFF was reported for participants with baseline liver fat MRI-PDFF ≥8.5% in Study Arm 2. FAS: All randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, Week 24
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Arms reported per protocol.
    End point values
    		 Arm 2 Cohort A: REGN4461 to REGN4461 Arm 2 Cohort B: REGN4461 to REGN4461 Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
    Number of subjects analysed
    4
    4
    8
    Units: percentage
    arithmetic mean (standard deviation)
        Week 12 (n=4, 4, 8)
    -17.05 ( 25.788 )
    -18.80 ( 17.300 )
    -17.92 ( 20.351 )
        Week 24 (n=4, 3, 7)
    -24.33 ( 27.151 )
    -19.53 ( 19.324 )
    -22.27 ( 22.353 )
    No statistical analyses for this end point

    Secondary: Change from baseline to weeks 12 and 24 on the daily lipodystrophy hunger questionnaire - highest hunger score

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    End point title
    		 Change from baseline to weeks 12 and 24 on the daily lipodystrophy hunger questionnaire - highest hunger score
    End point description
    The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The highest hunger score asked participants to rate their highest hunger that day on a scale from 0 to 4, with higher scores representing the higher perceived hunger. A negative change from baseline indicated a reduction in perceived hunger. FAS: All randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, Week 24
    End point values
    		 Arm 1 Cohort A: Placebo to REGN4461 Arm 2 Cohort A: REGN4461 to REGN4461 Arm 1 Cohort B: Placebo to REGN4461 Arm 2 Cohort B: REGN4461 to REGN4461 Arm 1 Combined Cohort A + B: Placebo to REGN4461 Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
    Number of subjects analysed
    6
    6
    4
    4
    10
    10
    Units: score on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=6, 6, 4, 4, 10, 10)
    -0.060 ( 0.9009 )
    -0.538 ( 0.4679 )
    -0.240 ( 0.2483 )
    -0.415 ( 0.7539 )
    -0.132 ( 0.6929 )
    -0.489 ( 0.5614 )
        Week 24 (n=5, 5, 3, 4, 8, 9)
    -0.330 ( 0.3684 )
    -0.018 ( 0.6228 )
    -0.383 ( 0.1550 )
    -0.285 ( 0.6180 )
    -0.350 ( 0.2919 )
    -0.137 ( 0.5975 )
    No statistical analyses for this end point

    Secondary: Change from baseline to weeks 12 and 24 on the daily lipodystrophy hunger questionnaire - lowest hunger score

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    End point title
    		 Change from baseline to weeks 12 and 24 on the daily lipodystrophy hunger questionnaire - lowest hunger score
    End point description
    The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The lowest hunger score asked participants to rate their lowest hunger that day on a scale from 0 to 4, with higher scores indicating higher perceived hunger. A negative change from baseline score indicated a reduction in perceived lowest hunger. FAS: All randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, Week 24
    End point values
    		 Arm 1 Cohort A: Placebo to REGN4461 Arm 2 Cohort A: REGN4461 to REGN4461 Arm 1 Cohort B: Placebo to REGN4461 Arm 2 Cohort B: REGN4461 to REGN4461 Arm 1 Combined Cohort A + B: Placebo to REGN4461 Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
    Number of subjects analysed
    6
    6
    4
    4
    10
    10
    Units: score on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=6, 6, 4, 4, 10, 10)
    0.185 ( 0.8013 )
    -0.475 ( 0.4630 )
    -0.338 ( 0.4287 )
    -0.173 ( 0.3625 )
    -0.024 ( 0.7006 )
    -0.354 ( 0.4328 )
        Week 24 (n=5, 5, 3, 4, 8, 9)
    -0.128 ( 0.0622 )
    0.046 ( 0.6776 )
    -0.103 ( 0.2230 )
    0.308 ( 0.9603 )
    -0.119 ( 0.1288 )
    0.162 ( 0.7710 )
    No statistical analyses for this end point

    Secondary: Change from baseline to weeks 12 and 24 on the daily lipodystrophy hunger questionnaire - felt hungry score

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    End point title
    		 Change from baseline to weeks 12 and 24 on the daily lipodystrophy hunger questionnaire - felt hungry score
    End point description
    The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy with higher scores indicating higher perceived hunger. A negative change from baseline score indicated a reduction in perceived hunger. FAS: All randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, Week 24
    End point values
    		 Arm 1 Cohort A: Placebo to REGN4461 Arm 2 Cohort A: REGN4461 to REGN4461 Arm 1 Cohort B: Placebo to REGN4461 Arm 2 Cohort B: REGN4461 to REGN4461 Arm 1 Combined Cohort A + B: Placebo to REGN4461 Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
    Number of subjects analysed
    6
    6
    4
    4
    10
    10
    Units: score on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=6, 6, 4, 4, 10, 10)
    0.248 ( 0.8642 )
    -0.550 ( 0.5334 )
    -0.168 ( 0.2900 )
    0.008 ( 0.9139 )
    0.082 ( 0.6993 )
    -0.327 ( 0.7206 )
        Week 24 (n=5, 5, 3, 4, 8, 9)
    0.016 ( 0.3932 )
    0.120 ( 0.4374 )
    -0.183 ( 0.0603 )
    -0.138 ( 0.6595 )
    -0.059 ( 0.3163 )
    0.006 ( 0.5265 )
    No statistical analyses for this end point

    Secondary: Change from baseline to weeks 12 and 24 on the daily lipodystrophy hunger questionnaire - fullness score

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    End point title
    		 Change from baseline to weeks 12 and 24 on the daily lipodystrophy hunger questionnaire - fullness score
    End point description
    The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The fullness score asked participants to rate how often they felt full after eating that day on a scale from 0 to 4, with higher scores indicating higher feeling of fullness. A negative change from baseline indicated a reduced feeling of fullness. FAS: All randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, Week 24
    End point values
    		 Arm 1 Cohort A: Placebo to REGN4461 Arm 2 Cohort A: REGN4461 to REGN4461 Arm 1 Cohort B: Placebo to REGN4461 Arm 2 Cohort B: REGN4461 to REGN4461 Arm 1 Combined Cohort A + B: Placebo to REGN4461 Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
    Number of subjects analysed
    6
    6
    4
    4
    10
    10
    Units: score on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=6, 6, 4, 4, 10, 10)
    0.063 ( 1.1988 )
    -0.267 ( 0.5381 )
    -1.180 ( 0.3764 )
    -0.535 ( 0.5736 )
    -0.434 ( 1.1216 )
    -0.374 ( 0.5383 )
        Week 24 (n=5, 5, 3, 4, 8, 9)
    -0.182 ( 0.6474 )
    0.012 ( 0.6474 )
    -1.193 ( 0.6630 )
    -0.178 ( 0.8032 )
    -0.561 ( 0.7994 )
    -0.072 ( 0.6793 )
    No statistical analyses for this end point

    Secondary: Number of participants with treatment-emergent adverse events (TEAEs)

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    End point title
    		 Number of participants with treatment-emergent adverse events (TEAEs)
    End point description
    The DB SAF included all participants who received any double-blind study drug in DBTP. The single-blind safety analysis set (SB SAF) included all randomized participants who received any single-blind study drug in the single-blind treatment period (SBTP).
    End point type
    Secondary
    End point timeframe
    Up to Day 169
    End point values
    		 DBTP Arm 1 Cohort A: Placebo DBTP Arm 2 Cohort A: REGN4461 DBTP Arm 1 Cohort B: Placebo DBTP Arm 2 Cohort B: REGN4461 DBTP Arm 1 Combined Cohort A + B: Placebo DBTP Arm 2 Combined Cohort A + B: REGN4461 SBTP Arm 1 Cohort A: Placebo to REGN4461 SBTP Arm 2 Cohort A: REGN4461 to REGN4461 SBTP Arm 1 Cohort B: Placebo to REGN4461 SBTP Arm 2 Cohort B: REGN4461 to REGN4461 SBTP Arm 1 Combined Cohort A + B: Placebo to REGN4461 SBTP Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
    Number of subjects analysed
    6
    6
    4
    4
    10
    10
    5
    6
    3
    4
    8
    10
    Units: participants
    4
    5
    4
    4
    8
    9
    3
    5
    3
    4
    6
    9
    No statistical analyses for this end point

    Secondary: Concentrations of REGN4461 in Serum

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    End point title
    		 Concentrations of REGN4461 in Serum
    End point description
    PK analysis set: All randomized participants who received any study drug and had at least 1 non-missing measurement of REGN4461 concentration following the first dose of study drug. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 1, 2, 3, 4, 5, 6, 9, 12, 13, 14, 15, 16, 17, 18, 21, 28, 32 and 36. Weeks 0 and 12 collected pre- and post-dose. All other time points were only pre-dose.
    End point values
    		 Arm 1 Combined Cohort A + B: Placebo to REGN4461 Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
    Number of subjects analysed
    10
    10
    Units: milligrams per liter (mg/L)
    arithmetic mean (standard deviation)
        Week 0 (pre-dose) (n=10, 10)
    0 ( 0 )
    0 ( 0 )
        Week 0 (post-dose) (n=10, 10)
    0 ( 0 )
    232 ( 83.8 )
        Week 1 (pre-dose) (n=9, 8)
    0 ( 0 )
    64.3 ( 24.9 )
        Week 2 (pre-dose) (n=9, 10)
    0 ( 0 )
    52.5 ( 13.3 )
        Week 3 (pre-dose) (n=10, 8)
    0 ( 0 )
    60.2 ( 19.0 )
        Week 4 (pre-dose) (n=8, 10)
    0 ( 0 )
    58.8 ( 23.8 )
        Week 5 (pre-dose) (n=10, 10)
    0 ( 0 )
    62.0 ( 36.1 )
        Week 6 (pre-dose) (n=10, 10)
    0 ( 0 )
    68.8 ( 38.8 )
        Week 9 (pre-dose) (n=10, 9)
    0 ( 0 )
    79.6 ( 49.2 )
        Week 12 (pre-dose) (n=8, 10)
    0 ( 0 )
    87.1 ( 57.8 )
        Week 12 (post-dose) (n=8, 10)
    252 ( 50.7 )
    87.6 ( 49.7 )
        Week 13 (pre-dose) (n=8, 10)
    62.4 ( 17.5 )
    97.6 ( 68.6 )
        Week 14 (pre-dose) (n=8, 10)
    56.6 ( 17.6 )
    92.8 ( 68.0 )
        Week 15 (pre-dose) (n=8, 10)
    64.2 ( 29.6 )
    90.5 ( 59.1 )
        Week 16 (pre-dose) (n=8, 10)
    68.8 ( 24.3 )
    103 ( 76.4 )
        Week 17 (pre-dose) (n=8, 10)
    73.4 ( 30.8 )
    92.1 ( 73.3 )
        Week 18 (pre-dose) (n=8, 10)
    75.1 ( 27.1 )
    95.0 ( 79.3 )
        Week 21 (pre-dose) (n=8, 9)
    89.3 ( 40.0 )
    72.9 ( 51.4 )
        Week 28 (pre-dose) (n=10, 10)
    10.9 ( 12.0 )
    16.0 ( 23.4 )
        Week 32 (pre-dose) (n=9, 10)
    0.0663 ( 0.0705 )
    0.189 ( 0.281 )
        Week 36 (pre-dose) (n=9, 10)
    0.0110 ( 0.0330 )
    0.0373 ( 0.0788 )
    No statistical analyses for this end point

    Secondary: Number of participants with treatment-emergent anti-drug antibody (ADA) response

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    End point title
    		 Number of participants with treatment-emergent anti-drug antibody (ADA) response
    End point description
    ADA analysis set: All treated participants who received any amount of study drug and had at least one non-missing anti-drug antibody result following the first dose of study drug.
    End point type
    Secondary
    End point timeframe
    Up to Day 281
    End point values
    		 Arm 1 Combined Cohort A + B: Placebo to REGN4461 Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
    Number of subjects analysed
    10
    10
    Units: participants
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From signing of informed consent up to day 281 (end of study)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    DBTP Arm 1 Cohort A: Placebo
    Reporting group description
    		 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP.

    Reporting group title
    DBTP Arm 2 Cohort A: REGN4461
    Reporting group description
    		 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP.

    Reporting group title
    SBTP Arm 1 Cohort A: Placebo to REGN4461
    Reporting group description
    		 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.

    Reporting group title
    SBTP Arm 2 Cohort A: REGN4461 to REGN4461
    Reporting group description
    		 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.

    Reporting group title
    SBTP Arm 1 Cohort B: Placebo to REGN4461
    Reporting group description
    		 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.

    Reporting group title
    SBTP Arm 2 Cohort B: REGN4461 to REGN4461
    Reporting group description
    		 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.

    Reporting group title
    DBTP Arm 1 Cohort B: Placebo
    Reporting group description
    		 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP.

    Reporting group title
    DBTP Arm 2 Cohort B: REGN4461
    Reporting group description
    		 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP.

    Serious adverse events
    		 DBTP Arm 1 Cohort A: Placebo DBTP Arm 2 Cohort A: REGN4461 SBTP Arm 1 Cohort A: Placebo to REGN4461 SBTP Arm 2 Cohort A: REGN4461 to REGN4461 SBTP Arm 1 Cohort B: Placebo to REGN4461 SBTP Arm 2 Cohort B: REGN4461 to REGN4461 DBTP Arm 1 Cohort B: Placebo DBTP Arm 2 Cohort B: REGN4461
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 5 (20.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis acute
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 DBTP Arm 1 Cohort A: Placebo DBTP Arm 2 Cohort A: REGN4461 SBTP Arm 1 Cohort A: Placebo to REGN4461 SBTP Arm 2 Cohort A: REGN4461 to REGN4461 SBTP Arm 1 Cohort B: Placebo to REGN4461 SBTP Arm 2 Cohort B: REGN4461 to REGN4461 DBTP Arm 1 Cohort B: Placebo DBTP Arm 2 Cohort B: REGN4461
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    6 / 6 (100.00%)
    3 / 5 (60.00%)
    5 / 6 (83.33%)
    3 / 3 (100.00%)
    4 / 4 (100.00%)
    4 / 4 (100.00%)
    4 / 4 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Melanocytic naevus
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Hypotension
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    5
    0
    0
    0
    0
    0
    2
    Peripheral swelling
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Asthenia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Decreased appetite
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    Chills
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Chest discomfort
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    Infusion site extravasation
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Injection site reaction
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    10
    0
    0
    0
    0
    1
    2
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    2 / 4 (50.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    Reproductive system and breast disorders
    Vaginal cyst
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Cough
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    Snoring
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Psychiatric disorders
    Affect lability
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Insomnia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Bipolar I disorder
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Poor quality sleep
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Suicidal ideation
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Investigations
    Carbohydrate antigen 19-9 increased
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Electrocardiogram abnormal
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    Haematocrit increased
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Fall
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Arterial injury
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Infusion related reaction
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    2 / 6 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    0
    2
    0
    2
    0
    0
    0
    2
    Congenital, familial and genetic disorders
    Muscular dystrophy
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Cardiac disorders
    Left ventricular hypertrophy
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Bundle branch block left
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Cardiac failure
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Defect conduction intraventricular
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 6 (50.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    3
    0
    0
    1
    0
    0
    0
    Cognitive disorder
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Brain fog
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    3
    1
    Migraine
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Mononeuropathy
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Neuralgia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Presyncope
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Lethargy
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Restless legs syndrome
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Splenomegaly
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Eye disorders
    Photophobia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 6 (33.33%)
    1 / 5 (20.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    2 / 4 (50.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    2
    1
    1
    0
    1
    2
    1
    Diarrhoea
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    2 / 3 (66.67%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    0
    2
    1
    2
    0
    Dyspepsia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Abdominal distension
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    0
    1
    0
    1
    0
    Ascites
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Gastritis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    Duodenal ulcer
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Dry mouth
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Constipation
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    0
    1
    Gastrointestinal wall thickening
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Plicated tongue
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Retching
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Varices oesophageal
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Seborrhoeic dermatitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Acne
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Rash
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Erythema
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Dermatitis contact
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    Alopecia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Skin exfoliation
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Skin lesion
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    Haematuria
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    2 / 6 (33.33%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    4
    1
    0
    1
    0
    0
    0
    1
    Back pain
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 6 (33.33%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    2
    0
    1
    0
    0
    0
    0
    Groin pain
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Flank pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    Neck pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    2 / 6 (33.33%)
    2 / 6 (33.33%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    1
    0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    COVID-19
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 6 (33.33%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    2 / 4 (50.00%)
         occurrences all number
    1
    2
    0
    1
    1
    0
    1
    2
    Bacterial infection
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Oral candidiasis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Cellulitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Onychomycosis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Fungal infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    Diverticulitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    Otitis externa
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Otitis media
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    3 / 4 (75.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    4
    0
    0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Pneumonia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Paronychia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 5 (40.00%)
    2 / 6 (33.33%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    2
    2
    1
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 6 (50.00%)
    1 / 5 (20.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    2 / 4 (50.00%)
         occurrences all number
    0
    3
    1
    1
    0
    1
    1
    2
    Tooth infection
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    1
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    4
    5
    0
    0
    0
    1
    0
    Hyperphagia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    2 / 5 (40.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    3
    0
    0
    0
    0
    0
    Hyponatraemia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Increased appetite
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 May 2022
    The main purpose of the amendment was to change the SC weekly maintenance dose of REGN4461.

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

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