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    Clinical Trial Results:
    A, single center, controlled, multiple dose, randomized study during two weeks, investigating the effect of the test formulation on efficacy, safety and markers for appetite regulation, glucose and lipid absorption and metabolism and body composition, in comparision with Xenical®.

    Summary
    EudraCT number
    		 2016-001055-50
    Trial protocol
    		 SE  
    Global end of trial date
    19 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Mar 2019
    First version publication date
    21 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EP-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Empros Pharma AB
    Sponsor organisation address
    Fogdevreten 2, Solna, Sweden, 17165
    Public contact
    Arvid Söderhäll, PhD, CEO, Empros Pharma AB, +46 (0)707233363, arvid.soderhall@emprospharma.com
    Scientific contact
    Arvid Söderhäll, PhD, CEO, Empros Pharma AB, +46 (0)707233363, arvid.soderhall@emprospharma.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
    19 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the appetite/tolerability score of the test formulation (EMP16-01 90/30) with the reference product (Xenical®).
    Protection of trial subjects
    The ICF included information that data would be recorded, collected and processed and could be transferred to European Economic Area (EEA) or non-EEA countries. In accordance with the EU Data Protection Directive (95/46/EC), the data would not identify any persons taking part in the study. The potential study subject was informed that by signing the ICF he approved that authorized representatives from Sponsor and CTC, the concerned IEC and Competent Authority had direct access to his medical records for verification of clinical study procedures. This agreement was substantiated in a separate document as per local requirements. The subject had the right to request access to his personal data and the right to request rectification of any data that was not correct and/or complete. The Investigator filed a Subject Identification List which included sufficient information to link records, i.e. the e-CRF and clinical records. This list will be preserved for possible future inspections/audits but has not been made available to the Sponsor except for monitoring or auditing purposes.
    Background therapy
    		 NA
    Evidence for comparator
    		 The study used a randomised, comparator-controlled design with four parallel treatment arms evaluating three different dose combinations of EMP16-01 (60/20, 90/30 or 120/40) in comparison to Xenical®. Xenical® was chosen as comparator since it is one of the most common weight-reducing agents on the market and has shown to be safe and to give clinical benefit [27]. Xenical® contains orlistat (120 mg) in a conventional oral dosage form, one of the two active pharmaceutical ingredients in EMP16-01.
    Actual start date of recruitment
    16 Aug 2016
    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
    Sweden: 67
    Worldwide total number of subjects
    67
    EEA total number of subjects
    67
    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)
    67
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects with overweight or obese, but otherwise healthy, were recruited from a database of healthy subjects at CTC and from advertising in newspapers, social media, flyers and TV- screens for commercial use. Date of first subject screened: 2016-08-16 The subjects were recruited at CTC Clinical Trial Consultants clinic in Uppsala, Sweden.

    Pre-assignment
    Screening details
    		 The planned sample size was 60 male subjects aged 24-60 years, inclusive, with a BMI of 32- 40 kg/m2 or a BMI of 30-32 kg/m2 combined with a waist circumference above 102 cm.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The study was not blinded thus no attempt was made to alter the appearance of the Xenical® capsule.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment arm 1
    Arm description
    		 EMP16-01 60/20; 60 mg orlistat and 20 mg acarbose
    Arm type
    		 Experimental

    Investigational medicinal product name
    EMP16-01 60/20
    Investigational medicinal product code
    EMP16-01 60/20
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    EMP16-01 60/20; 60 mg orlistat and 20 mg acarbose, capsules. The IMP was administered orally TID together with all three main meals for 14 consecutive days. On study days 1 and 14 (Visits 2 and 4) the IMP was administered at the clinic. For the remaining days, the IMP was self-administered by the subject at home.

    Arm title
    		 Treatment arm 2
    Arm description
    		 EMP16-01 90/30; 90 mg orlistat and 30 mg acarbose
    Arm type
    		 Experimental

    Investigational medicinal product name
    EMP16-01 90/30
    Investigational medicinal product code
    EMP16-01 90/30
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    EMP16-01 90/30; 90 mg orlistat and 30 mg acarbose, capsules. The IMP was administered orally TID together with all three main meals for 14 consecutive days. On study days 1 and 14 (Visits 2 and 4) the IMP was administered at the clinic. For the remaining days, the IMP was self-administered by the subject at home.

    Arm title
    		 Treatment arm 3
    Arm description
    		 EMP16-01 120/40; 120 mg orlistat and 40 mg acarbose
    Arm type
    		 Experimental

    Investigational medicinal product name
    EMP16-01 120/40
    Investigational medicinal product code
    EMP16-01 120/40
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    EMP16-01 120/40; 120 mg orlistat and 40 mg acarbose, capsules. The IMP was administered orally TID together with all three main meals for 14 consecutive days. On study days 1 and 14 (Visits 2 and 4) the IMP was administered at the clinic. For the remaining days, the IMP was self-administered by the subject at home.

    Arm title
    		 Treatment arm 4
    Arm description
    		 Xenical®; 120 mg orlistat
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Xenical® 120 mg
    Investigational medicinal product code
    Xenical® 120 mg
    Other name
    orlistat
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Xenical®; 120 mg orlistat, capsules. The IMP was administered orally TID together with all three main meals for 14 consecutive days. On study days 1 and 14 (Visits 2 and 4) the IMP was administered at the clinic. For the remaining days, the IMP was self-administered by the subject at home.

    Number of subjects in period 1
    		Treatment arm 1 Treatment arm 2 Treatment arm 3 Treatment arm 4
    Started
    17
    17
    16
    17
    Completed
    16
    17
    16
    15
    Not completed
    1
    0
    0
    2
         Consent withdrawn by subject
    -
    -
    -
    1
         Adverse event, non-fatal
    -
    -
    -
    1
         Protocol deviation
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment arm 1
    Reporting group description
    		 EMP16-01 60/20; 60 mg orlistat and 20 mg acarbose

    Reporting group title
    Treatment arm 2
    Reporting group description
    		 EMP16-01 90/30; 90 mg orlistat and 30 mg acarbose

    Reporting group title
    Treatment arm 3
    Reporting group description
    		 EMP16-01 120/40; 120 mg orlistat and 40 mg acarbose

    Reporting group title
    Treatment arm 4
    Reporting group description
    		 Xenical®; 120 mg orlistat

    Reporting group values
    		 Treatment arm 1 Treatment arm 2 Treatment arm 3 Treatment arm 4 Total
    Number of subjects
    		 17 17 16 17 67
    Age categorical
    All included subjects were male adults 24-60 years.
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 17 17 16 17 67
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    The mean age was 42.9 (9.1) years (median 44.0) among subjects in the FAS population. No major differences across treatment groups were seen.
    Units: years
        arithmetic mean (standard deviation)
    		 40.47 ( 8.65 ) 43.35 ( 8.5 ) 42.25 ( 9.6 ) 45.35 ( 9.77 ) -
    Gender categorical
    Only male subjects participated in the study.
    Units: Subjects
        Female
    		 0 0 0 0 0
        Male
    		 17 17 16 17 67
    BMI
    Weight and height were measured at screening and BMI (Body Mass Index) was calculated.
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 34.47 ( 2.98 ) 34.12 ( 2.83 ) 34.75 ( 2.32 ) 35.41 ( 2.83 ) -

    End points

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    End points reporting groups
    Reporting group title
    Treatment arm 1
    Reporting group description
    		 EMP16-01 60/20; 60 mg orlistat and 20 mg acarbose

    Reporting group title
    Treatment arm 2
    Reporting group description
    		 EMP16-01 90/30; 90 mg orlistat and 30 mg acarbose

    Reporting group title
    Treatment arm 3
    Reporting group description
    		 EMP16-01 120/40; 120 mg orlistat and 40 mg acarbose

    Reporting group title
    Treatment arm 4
    Reporting group description
    		 Xenical®; 120 mg orlistat

    Primary: Appetite/tolerability score EMP16-01 90/30 versus Xenical

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    End point title
    		 Appetite/tolerability score EMP16-01 90/30 versus Xenical [1]
    End point description
    The primary objective of the study was to compare the appetite/tolerability score of the test formulation (EMP16-01 90/30) with the reference product (Xenical®). The appetite/tolerability score, i.e. ratio between subjective appetite score (sum of appetite questions, measured with questionnaire) and GI symptoms score (sum of GI symptoms such as diarrhoea, flatulence, oily spotting, gastric distention and frequency and intensity of nausea and pain, measured with questionnaire). Daily scores were tabulated to form a 14 days’ composite appetite/tolerability score. t-test for pairwise comparison using total score (FAS)
    End point type
    Primary
    End point timeframe
    From baseline to last dose.
    Notes
    [1] - 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: The objective was to compare the appetite/tolerability score of the test formulation (EMP 16-01 90/30, treatment arm 2) with the reference product (Xenical, treatment arm 4)
    End point values
    		 Treatment arm 2 Treatment arm 4
    Number of subjects analysed
    17
    16
    Units: Score
    arithmetic mean (standard deviation)
        Baseline
    14.57 ( 20.26 )
    16.32 ( 21.14 )
        During study
    3.60 ( 3.41 )
    2.90 ( 1.92 )
        Difference in ratio
    -11.0 ( 21.29 )
    -14.0 ( 22.27 )
        Rel. difference in ratio
    -62.8 ( 46.55 )
    -72.4 ( 28.13 )
    Statistical analysis title
    		 Appetite/tolerability score
    Statistical analysis description
    Descriptive statistics of the appetite/tolerability score ratio at baseline and at last visit together with the absolute and relative changes using the total score are presented for the FAS population. The absolute and relative changes have been analysed using an un-paired Student’s t-test.
    Comparison groups
    Treatment arm 2 v Treatment arm 4
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≥ 0.05
    Method
    		 Student´s t-test
    Confidence interval

    Secondary: Appetite/tolerability (GSS) score, pairwise comparisons

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    End point title
    		 Appetite/tolerability (GSS) score, pairwise comparisons
    End point description
    Pairwise comparisons for all combinations other than the primary outcome have been made. t-test for pairwise comparison using total score (FAS)
    End point type
    Secondary
    End point timeframe
    From baseline to day 14
    End point values
    		 Treatment arm 1 Treatment arm 2 Treatment arm 3 Treatment arm 4
    Number of subjects analysed
    17
    17
    16
    16 [2]
    Units: Score
    arithmetic mean (standard deviation)
        Baseline
    15.62 ( 25.47 )
    14.57 ( 20.26 )
    25.49 ( 23.20 )
    16.32 ( 21.14 )
        During study
    4.07 ( 2.54 )
    3.60 ( 3.41 )
    2.66 ( 2.23 )
    2.90 ( 1.92 )
    Notes
    [2] - At baseline: 17 subjects During study: 16 subjects
    Statistical analysis title
    		 Appetite/tolerability score, pairwise comparisons
    Statistical analysis description
    Descriptive statistics for the score ratio at baseline and at last visit together with the absolute and relative changes using the total score and the mean score, respectively, are presented for the FAS population. The absolute and relative changes have been analysed using an un-paired Student’s t-test. The absolute and relative changes have also been analysed using analysis of covariance with treatment, age, BMI, fasting glucose at baseline and baseline ratio as covariates.
    Comparison groups
    Treatment arm 1 v Treatment arm 2 v Treatment arm 3 v Treatment arm 4
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05 [3]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [3] - Some statistically significant differences were detected.

    Secondary: Global assessment of satisfaction

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    End point title
    		 Global assessment of satisfaction
    End point description
    At completion of the last questionnaire (at lunch Day 14), the subject was asked to answer the question: “How probable is it that you would take this drug for an extended time?” The question was answered based on a scale from 0 to 9 where 0 represented Unlikely and 9 represented Very likely.
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    		 Treatment arm 1 Treatment arm 2 Treatment arm 3 Treatment arm 4
    Number of subjects analysed
    16
    17
    16
    15
    Units: Mean score
        arithmetic mean (standard deviation)
    6.00 ( 2.58 )
    6.47 ( 2.37 )
    5.75 ( 3.15 )
    5.87 ( 2.39 )
    Statistical analysis title
    		 Global assessment of satisfaction
    Statistical analysis description
    Descriptive statistics are presented by treatment group for the FAS population. Pairwise comparisons have been made across treatment groups using Student’s t-test.
    Comparison groups
    Treatment arm 1 v Treatment arm 2 v Treatment arm 3 v Treatment arm 4
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05 [4]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [4] - The mean score on a scale from 0-9 was similar across treatment groups. No statistically significant differences were detected.

    Secondary: Plasma pharmacokinetics of orlistat - AUClast

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    End point title
    		 Plasma pharmacokinetics of orlistat - AUClast
    End point description
    Blood samples for determination of concentration of orlistat in plasma were drawn from a peripheral vein at time-points at Visit 2 and Visit 4.
    End point type
    Secondary
    End point timeframe
    At Visit 2 and Visit 4
    End point values
    		 Treatment arm 1 Treatment arm 2 Treatment arm 3 Treatment arm 4
    Number of subjects analysed
    15 [5]
    17
    16
    14 [6]
    Units: nmol/h * h
    arithmetic mean (standard deviation)
        Visit 2
    0.61 ( 0.48 )
    1.27 ( 1.19 )
    1.13 ( 1.05 )
    3.94 ( 3.48 )
        Visit 4
    0.99 ( 0.51 )
    1.53 ( 1.10 )
    1.51 ( 1.36 )
    3.90 ( 3.31 )
    Notes
    [5] - Visit 2: 17 subjects were analysed Visit 4: 15 subjects were analysed
    [6] - Visit 2: 17 subjects were analysed Visit 4: 14 subjects were analysed
    Statistical analysis title
    		 Plasma pharmacokinetics of orlistat - AUClast
    Statistical analysis description
    There were minor differences in the mean plasma concentrations of orlistat after administration of any of the EMP16-01 doses compared with Xenical®. The GI absorption of orlistat from both test and reference dosage forms was higher after lunch than after breakfast.
    Comparison groups
    Treatment arm 2 v Treatment arm 3 v Treatment arm 1 v Treatment arm 4
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05 [7]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [7] - No statistically significant differences were detected.

    Secondary: Plasma pharmacokinetics of orlistat - Tmax

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    End point title
    		 Plasma pharmacokinetics of orlistat - Tmax
    End point description
    Blood samples for determination of concentration of orlistat in plasma were drawn from a peripheral vein at time-points at Visit 2 and Visit 4.
    End point type
    Secondary
    End point timeframe
    At Visit 2 and Visit 4
    End point values
    		 Treatment arm 1 Treatment arm 2 Treatment arm 3 Treatment arm 4
    Number of subjects analysed
    15 [8]
    17
    16
    15 [9]
    Units: hour
    arithmetic mean (standard deviation)
        Visit 2
    5.78 ( 0.56 )
    5.95 ( 0.17 )
    5.74 ( 0.66 )
    5.47 ( 1.32 )
        Visit 4
    4.98 ( 1.85 )
    5.63 ( 1.03 )
    6.00 ( 0.00 )
    5.90 ( 0.21 )
    Notes
    [8] - Visit 2: 17 subjects were analysed Visit 4: 15 subjects were analysed
    [9] - Visit 2: 17 subjects were analysed Visit 4: 15 subjects were analysed
    Statistical analysis title
    		 Plasma pharmacokinetics of orlistat - Tmax
    Comparison groups
    Treatment arm 1 v Treatment arm 2 v Treatment arm 3 v Treatment arm 4
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05 [10]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [10] - No statistically significant differences were detected.

    Secondary: Plasma pharmacokinetics of orlistat - Cmax

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    End point title
    		 Plasma pharmacokinetics of orlistat - Cmax
    End point description
    Blood samples for determination of concentration of orlistat in plasma were drawn from a peripheral vein at time-points at Visit 2 and Visit 4.
    End point type
    Secondary
    End point timeframe
    At Visit 2 and Visit 4
    End point values
    		 Treatment arm 1 Treatment arm 2 Treatment arm 3 Treatment arm 4
    Number of subjects analysed
    15 [11]
    17
    16
    15 [12]
    Units: nmol/L
    arithmetic mean (standard deviation)
        Visit 2
    0.68 ( 0.57 )
    1.26 ( 1.42 )
    1.05 ( 0.87 )
    3.32 ( 1.93 )
        Visit 4
    0.93 ( 9.70 )
    1.55 ( 1.13 )
    1.24 ( 1.10 )
    2.90 ( 2.12 )
    Notes
    [11] - Visit 2: 17 subjects were analysed Visit 4: 15 subjects were analysed
    [12] - Visit 2: 17 subjects were analysed Visit 4: 15 subjects were analysed
    Statistical analysis title
    		 Plasma pharmacokinetics of orlistat - Cmax
    Comparison groups
    Treatment arm 1 v Treatment arm 2 v Treatment arm 3 v Treatment arm 4
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05 [13]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [13] - No statistically significant differences were detected.

    Secondary: Biomarkers in plasma - AUClast

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    End point title
    		 Biomarkers in plasma - AUClast
    End point description
    Samples for analyses of plasma/serum kinetics for the biomarkers glucose, insulin, C-peptide, glucagon, TG, GLP-1, GIP and CCK were drawn from a peripheral vein at time-points at Visit 2 and Visit 4.
    End point type
    Secondary
    End point timeframe
    At Visit 2 and Visit 4
    End point values
    		 Treatment arm 1 Treatment arm 2 Treatment arm 3 Treatment arm 4
    Number of subjects analysed
    16 [14]
    17
    16
    15 [15]
    Units: nmol/h * h
    arithmetic mean (standard deviation)
        C-Peptid Visit 2
    12.29 ( 2.25 )
    11.75 ( 3.11 )
    11.84 ( 13.33 )
    14.44 ( 4.58 )
        C-Peptid Visit 4
    11.88 ( 2.30 )
    11.49 ( 2.78 )
    11.12 ( 3.02 )
    12.03 ( 3.15 )
        GIP Visit 2
    859.1 ( 351.1 )
    876.5 ( 368.8 )
    721.7 ( 237.0 )
    903.7 ( 248.5 )
        GIP Visit 4
    891.9 ( 351.6 )
    1087 ( 609.8 )
    850.6 ( 251.7 )
    1071 ( 380.1 )
        GLP1 Visit 2
    84.37 ( 22.25 )
    76.24 ( 16.75 )
    86.54 ( 28.8 )
    83.34 ( 24.40 )
        GLP1 Visit 4
    94.62 ( 24.03 )
    81.88 ( 14.53 )
    89.57 ( 21.90 )
    84.79 ( 24.85 )
        Glucagon Visit 2
    34.60 ( 18.06 )
    27.92 ( 9.87 )
    35.45 ( 15.54 )
    31.64 ( 12.52 )
        Glucagon Visit 4
    37.38 ( 17.05 )
    26.67 ( 9.35 )
    34.37 ( 10.57 )
    27.55 ( 12.84 )
        P-Glucose Visit 2
    33.75 ( 3.61 )
    34.03 ( 3.43 )
    33.28 ( 3.06 )
    37.37 ( 3.79 )
        P-Glucose Visit 4
    33.11 ( 3.02 )
    34.61 ( 3.87 )
    33.89 ( 3.51 )
    35.41 ( 5.01 )
        P-Triglycerides Visit 2
    14.02 ( 3.99 )
    13.28 ( 4.17 )
    18.94 ( 9.52 )
    15.33 ( 6.57 )
        P-Triglycerides Visit 4
    15.63 ( 5.32 )
    12.80 ( 3.22 )
    16.38 ( 7.30 )
    13.53 ( 5.01 )
        S-Insulin Visit 2
    281.9 ( 102.0 )
    256.4 ( 137.8 )
    274.9 ( 119.2 )
    409.9 ( 293.6 )
        S-Insulin Visit 4
    272.7 ( 93.71 )
    244.1 ( 109.3 )
    236.1 ( 110.0 )
    270.9 ( 112.2 )
    Notes
    [14] - Visit 2: 17 subjects were analysed Visit 4: 16 subjects were analysed
    [15] - Visit 2: 17 subjects were analysed Visit 4: 15 subjects were analysed
    Statistical analysis title
    		 Biomarkers in plasma - AUClast
    Comparison groups
    Treatment arm 1 v Treatment arm 2 v Treatment arm 3 v Treatment arm 4
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05 [16]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [16] - Some statistically significant differences were detected.

    Secondary: Biomarkers in plasma - Tmax

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    End point title
    		 Biomarkers in plasma - Tmax
    End point description
    Samples for analyses of plasma/serum kinetics for the biomarkers glucose, insulin, C-peptide, glucagon, TG, GLP-1, GIP and CCK were drawn from a peripheral vein at time-points at Visit 2 and Visit 4.
    End point type
    Secondary
    End point timeframe
    At Visit 2 and Visit 4
    End point values
    		 Treatment arm 1 Treatment arm 2 Treatment arm 3 Treatment arm 4
    Number of subjects analysed
    17 [17]
    17
    16
    15 [18]
    Units: hour
    arithmetic mean (standard deviation)
        C-Peptid Visit 2
    5.03 ( 1.26 )
    3.89 ( 1.94 )
    4.16 ( 1.86 )
    5.15 ( 0.63 )
        C-Peptid Visit 4
    4.42 ( 1.82 )
    4.21 ( 1.88 )
    4.59 ( 1.49 )
    4.75 ( 1.22 )
        GIP Visit 2
    0.71 ( 0.40 )
    0.85 ( 0.39 )
    0.94 ( 0.40 )
    0.76 ( 0.36 )
        GIP Visit 4
    0.85 ( 0.34 )
    0.91 ( 0.32 )
    0.91 ( 0.42 )
    0.82 ( 0.52 )
        GLP1 Visit 2
    4.83 ( 0.61 )
    4.47 ( 1.35 )
    4.31 ( 1.26 )
    4.24 ( 1.51 )
        GLP1 Visit 4
    4.55 ( 0.14 )
    4.28 ( 1.29 )
    4.46 ( 1.12 )
    4.05 ( 1.94 )
        Glucagon Visit 2
    1.02 ( 0.48 )
    1.19 ( 0.54 )
    1.08 ( 0.53 )
    0.93 ( 0.50 )
        Glucagon Visit 4
    1.26 ( 0.34 )
    1.12 ( 0.42 )
    1.20 ( 0.36 )
    1.05 ( 0.57 )
        P-Glucose Visit 2
    3.06 ( 2.19 )
    3.71 ( 2.03 )
    2.78 ( 1.98 )
    4.06 ( 1.67 )
        P-Glucose Visit 4
    3.73 ( 2.22 )
    3.47 ( 2.13 )
    3.27 ( 2.10 )
    4.52 ( 1.38 )
        P-Triglycerides Visit 2
    5.65 ( 0.98 )
    5.80 ( 0.44 )
    5.91 ( 0.27 )
    5.83 ( 0.42 )
        P-Triglycerides Visit 4
    5.95 ( 0.18 )
    5.63 ( 1.22 )
    5.85 ( 0.35 )
    5.58 ( 1.61 )
        S-Insulin Visit 2
    3.35 ( 2.22 )
    3.26 ( 2.05 )
    2.56 ( 1.92 )
    4.65 ( 1.60 )
        S-Insulin Visit 4
    3.20 ( 2.33 )
    2.62 ( 2.24 )
    2.70 ( 2.15 )
    4.22 ( 1.89 )
    Notes
    [17] - Visit 2: 17 subjects were analysed Visit 4: 16 subjects were analysed
    [18] - Visit 2: 17 subjects were analysed Visit 4: 15 subjects were analysed
    Statistical analysis title
    		 Biomarkers in plasma - Tmax
    Comparison groups
    Treatment arm 1 v Treatment arm 2 v Treatment arm 3 v Treatment arm 4
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05 [19]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [19] - No statistically significant differences were detected.

    Secondary: Biomarkers in plasma - Cmax

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    End point title
    		 Biomarkers in plasma - Cmax
    End point description
    Samples for analyses of plasma/serum kinetics for the biomarkers glucose, insulin, C-peptide, glucagon, TG, GLP-1, GIP and CCK were drawn from a peripheral vein at time-points at Visit 2 and Visit 4.
    End point type
    Secondary
    End point timeframe
    At Visit 2 and Visit 4
    End point values
    		 Treatment arm 1 Treatment arm 2 Treatment arm 3 Treatment arm 4
    Number of subjects analysed
    16 [20]
    17
    16
    15 [21]
    Units: nmol/L
    arithmetic mean (standard deviation)
        C-Peptid Visit 2
    2.87 ( 0.53 )
    2.79 ( 0.72 )
    2.62 ( 0.73 )
    3.84 ( 1.31 )
        C-Peptid Visit 4
    2.96 ( 0.70 )
    2.69 ( 0.70 )
    2.68 ( 0.81 )
    3.33 ( 1.01 )
        GIP Visit 2
    693.8 ( 272.1 )
    732.8 ( 281.6 )
    583.9 ( 170.3 )
    711.0 ( 185.1 )
        GIP Visit 4
    776.9 ( 308.9 )
    904.8 ( 545.4 )
    700.9 ( 213.8 )
    872.9 ( 324.4 )
        GLP1 Visit 2
    20.60 ( 5.80 )
    19.98 ( 5.92 )
    22.53 ( 8.41 )
    20.56 ( 5.97 )
        GLP1 Visit 4
    24.00 ( 6.98 )
    20.44 ( 4.17 )
    21.79 ( 6.22 )
    20.23 ( 6.04 )
        Glucagon Visit 2
    24.36 ( 12.56 )
    20.96 ( 8.07 )
    25.79 ( 11.51 )
    22.11 ( 9.55 )
        Glucagon Visit 4
    26.62 ( 10.72 )
    18.98 ( 6.74 )
    24.58 ( 7.66 )
    20.75 ( 9.04 )
        P-Glucose Visit 2
    6.24 ( 0.66 )
    6.45 ( 0.78 )
    6.09 ( 0.68 )
    7.59 ( 1.19 )
        P-Glucose Visit 4
    6.26 ( 0.50 )
    6.48 ( 0.87 )
    6.16 ( 0.90 )
    7.38 ( 1.66 )
        P-Triglycerides Visit 2
    3.18 ( 0.71 )
    2.97 ( 0.95 )
    3.89 ( 1.85 )
    3.37 ( 1.13 )
        P-Triglycerides Visit 4
    3.64 ( 1.14 )
    3.01 ( 0.77 )
    3.33 ( 1.38 )
    2.87 ( 0.97 )
        S-Insulin Visit 2
    77.76 ( 25.44 )
    79.18 ( 37.93 )
    76.55 ( 37.22 )
    144.1 ( 105.3 )
        S-Insulin Visit 4
    85.81 ( 25.11 )
    73.24 ( 30.24 )
    73.94 ( 34.26 )
    98.60 ( 54.06 )
    Notes
    [20] - Visit 2: 17 subjects were analysed Visit 4: 16 subjects were analysed
    [21] - Visit 2: 17 subjects were analysed Visit 4: 15 subjects were analysed
    Statistical analysis title
    		 Biomarkers in plasma - Cmax
    Comparison groups
    Treatment arm 1 v Treatment arm 2 v Treatment arm 3 v Treatment arm 4
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05 [22]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [22] - Some statistically significant differences were detected.

    Secondary: Body composition - fat

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    End point title
    		 Body composition - fat
    End point description
    Body composition (% total body fat, % total water) was assessed by bio-impedance (Tanita BC-545N).
    End point type
    Secondary
    End point timeframe
    From Visit 2 (baseline) to Visit 4
    End point values
    		 Treatment arm 1 Treatment arm 2 Treatment arm 3 Treatment arm 4
    Number of subjects analysed
    15 [23]
    17
    16
    15 [24]
    Units: percent
    arithmetic mean (standard deviation)
        Visit 2
    32.67 ( 2.66 )
    31.82 ( 4.72 )
    32.19 ( 4.55 )
    32.82 ( 4.89 )
        Visit 4
    32.38 ( 2.83 )
    31.76 ( 4.66 )
    32.06 ( 3.92 )
    33.07 ( 4.20 )
    Notes
    [23] - Visit 2: 15 subjects Visit 4: 16 subjects
    [24] - Visit 2: 17 subjects Visit 4: 15 subjects
    Statistical analysis title
    		 Body composition - fat
    Statistical analysis description
    Descriptive statistics for body weight, body composition and waist circumference at Visit 2 (baseline) and Visit 4 together with absolute and relative changes from Visit 2 to Visit 4. Differences between treatment groups have been analysed using the Wilcoxon rank-sum test.
    Comparison groups
    Treatment arm 1 v Treatment arm 2 v Treatment arm 3 v Treatment arm 4
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05 [25]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [25] - No statistically significant differences were detected.

    Secondary: Body composition - total water

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    End point title
    		 Body composition - total water
    End point description
    Body composition (% total body fat, % total water) was assessed by bio-impedance (Tanita BC-545N).
    End point type
    Secondary
    End point timeframe
    From Visit 2 (baseline) to Visit 4
    End point values
    		 Treatment arm 1 Treatment arm 2 Treatment arm 3 Treatment arm 4
    Number of subjects analysed
    15 [26]
    17
    16
    15 [27]
    Units: percent
    arithmetic mean (standard deviation)
        Visit 2
    47.53 ( 2.59 )
    48.24 ( 3.67 )
    48.13 ( 3.54 )
    47.71 ( 3.57 )
        Visit 4
    47.75 ( 2.74 )
    48.18 ( 3.57 )
    48.13 ( 3.07 )
    47.33 ( 3.13 )
    Notes
    [26] - Visit 2: 15 subjects Visit 4: 16 subjects
    [27] - Visit 2: 17 subjects Visit 4: 15 subjects
    Statistical analysis title
    		 Body composition - total water
    Statistical analysis description
    Descriptive statistics for body weight, body composition and waist circumference at Visit 2 (baseline) and Visit 4 together with absolute and relative changes from Visit 2 to Visit 4 are presented. Differences between treatment groups have been analysed using the Wilcoxon rank-sum test.
    Comparison groups
    Treatment arm 1 v Treatment arm 2 v Treatment arm 3 v Treatment arm 4
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05 [28]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [28] - No statistically significant differences were detected.

    Secondary: Body composition - weight

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    End point title
    		 Body composition - weight
    End point description
    The body weight was assessed wearing light clothing and no shoes and was read in kilogram (kg), to one decimal.
    End point type
    Secondary
    End point timeframe
    From Visit 2 (baseline) to Visit 4
    End point values
    		 Treatment arm 1 Treatment arm 2 Treatment arm 3 Treatment arm 4
    Number of subjects analysed
    15 [29]
    17
    16
    15 [30]
    Units: kilogram
    arithmetic mean (standard deviation)
        Visit 2
    115.0 ( 15.68 )
    110.2 ( 13.18 )
    112.8 ( 10.59 )
    112.6 ( 13.48 )
        Visit 4
    113.3 ( 16.66 )
    109.6 ( 12.91 )
    111.5 ( 10.20 )
    110.9 ( 14.52 )
    Notes
    [29] - Visit 2: 15 subjects Visit 4: 16 subjects
    [30] - Visit 2: 17 subjects Visit 4: 15 subjects
    Statistical analysis title
    		 Body composition - weight
    Statistical analysis description
    Descriptive statistics for body weight, body composition and waist circumference at Visit 2 (baseline) and Visit 4 together with absolute and relative changes from Visit 2 to Visit 4 are presented. Differences between treatment groups have been analysed using the Wilcoxon rank-sum test.
    Comparison groups
    Treatment arm 1 v Treatment arm 2 v Treatment arm 3 v Treatment arm 4
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [31]
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [31] - The only statistically significant difference between treatment groups was seen in the PPS population when comparing EMP16-01 90/30 with Xenical®. The mean weight change from baseline to end of treatment was -0.56 kg in the EMP16-01 90/30 treatment group as compared to -1.57 kg after treatment with Xenical®. The p-value for the absolute and relative differences was 0.05.

    Secondary: Body composition - waist

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    End point title
    		 Body composition - waist
    End point description
    The waist circumference was measured midway between the lowest rib and the iliac crest. Measurements were done at the end of a normal exhalation and in a standing position.
    End point type
    Secondary
    End point timeframe
    From Visit 2 (baseline) to Visit 4
    End point values
    		 Treatment arm 1 Treatment arm 2 Treatment arm 3 Treatment arm 4
    Number of subjects analysed
    16 [32]
    17
    16
    15 [33]
    Units: centimeter
    arithmetic mean (standard deviation)
        Visit 2
    119.2 ( 9.38 )
    118.6 ( 8.35 )
    120.6 ( 10.21 )
    118.8 ( 9.05 )
        Visit 4
    119.3 ( 9.69 )
    116.8 ( 8.71 )
    118.6 ( 9.12 )
    117.5 ( 9.46 )
    Notes
    [32] - Visit 2: 17 subjects Visit 4: 16 subjects
    [33] - Visit 2: 17 subjects Visit 4: 15 subjects
    Statistical analysis title
    		 Body composition - waist
    Comparison groups
    Treatment arm 1 v Treatment arm 2 v Treatment arm 3 v Treatment arm 4
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05 [34]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [34] - No statistically significant differences were detected.

    Secondary: Activity pattern

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    End point title
    		 Activity pattern
    End point description
    Daily activity (amount and intensity) was subjectively assessed using the question "Have you performed any heavy exercise of longer duration (more than 20 min)?", included in the questionnaire completed by the subject three times per day.
    End point type
    Secondary
    End point timeframe
    Day -3 to day 14
    End point values
    		 Treatment arm 1 Treatment arm 2 Treatment arm 3 Treatment arm 4
    Number of subjects analysed
    15 [35]
    16 [36]
    16
    15 [37]
    Units: Number of subjects answering "yes"
        Day -3
    2
    5
    5
    1
        Day -2
    1
    2
    3
    4
        Day -1
    2
    1
    5
    5
        Day 1
    0
    0
    0
    1
        Day 2
    4
    1
    5
    3
        Day 3
    6
    3
    4
    3
        Day 4
    4
    1
    4
    2
        Day 5
    7
    4
    4
    5
        Day 6
    4
    3
    7
    2
        Day 7
    3
    4
    4
    3
        Day 8
    2
    4
    4
    6
        Day 9
    3
    5
    9
    4
        Day 10
    4
    4
    7
    2
        Day 11
    3
    2
    4
    3
        Day 12
    5
    7
    1
    4
        Day 13
    2
    5
    3
    3
        Day 14
    0
    0
    0
    0
    Notes
    [35] - Day -3 to day 3: 17 subjects Day 4 to day 13: 16 subjects Day 14: 15 subjects
    [36] - Day -3 to -1: 17 subjects Day 1: 16 subjects Day 2: 18 subjects Day 3-14: 17 subjects
    [37] - Day -3 to -1: 17 subjects Day 1 to 4: 16 subjects Day 5 to 14: 15 subjects
    Statistical analysis title
    		 Activity pattern
    Statistical analysis description
    Pairwise comparisons across treatment groups have been made using Student’s t-test. Overall, no clinically relevant difference between treatment arms in self-reported sleep and physically activity was found. Statistically significant differences between treatment groups were found for individual days.
    Comparison groups
    Treatment arm 1 v Treatment arm 2 v Treatment arm 3 v Treatment arm 4
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [38]
    P-value
    		 > 0.05
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [38] - The proportion of subjects answering Yes to the question “Have you performed any heavy exercise of longer duration (more than 20 min)?” was significantly higher on Day 10 after treatment with EMP16-01 120/4, as compared to Xenical®, in both populations (p- value=0.030 [FAS] and 0.008 [PPS]). On Day 9, EMP16-01 120/4 had a significantly better effect on the activity pattern than both EMP16-01 90/30 (p-value=0.026) and Xenical® p-value=0.028.

    Secondary: Sleep pattern

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    End point title
    		 Sleep pattern
    End point description
    Daily sleep (duration and quality) was subjectively assessed using the question "Did you have a normal night´s sleep (about as long and as deep as usual?", included in the questionnaire completed by the subject three times per day.
    End point type
    Secondary
    End point timeframe
    Day -3 to Day 14
    End point values
    		 Treatment arm 1 Treatment arm 2 Treatment arm 3 Treatment arm 4
    Number of subjects analysed
    15 [39]
    16 [40]
    16
    14 [41]
    Units: Number of subjects answering "yes"
        Day -3
    16
    16
    16
    14
        Day -2
    15
    15
    16
    16
        Day -1
    16
    16
    14
    15
        Day 1
    14
    14
    16
    11
        Day 2
    16
    16
    16
    15
        Day 3
    16
    16
    15
    15
        Day 4
    15
    15
    15
    13
        Day 5
    16
    14
    14
    14
        Day 6
    15
    17
    16
    14
        Day 7
    14
    16
    15
    12
        Day 8
    15
    17
    16
    12
        Day 9
    13
    16
    13
    14
        Day 10
    13
    16
    14
    14
        Day 11
    14
    13
    14
    14
        Day 12
    13
    15
    13
    14
        Day 13
    14
    16
    14
    12
        Day 14
    11
    14
    15
    9
    Notes
    [39] - Day -3 to 3: 17 subjects Day 4 to 13: 16 subjects Day 14: 15 subjects
    [40] - Day -3, -1 and 3-14: 17 subjects Day -2 and 1: 16 subjects Day 2: 18 subjects
    [41] - Day -3 to -1: 17 subjects Day 1-4: 16 subjects Day 5-6, 9-12, 14: 15 subjects Day 7-8, 13: 14 sub
    Statistical analysis title
    		 Sleep pattern
    Statistical analysis description
    Pairwise comparisons across treatment groups have been made using Student’s t-test. Overall, no clinically relevant difference between treatment arms in self-reported sleep and physically activity was found. Statistically significant differences between treatment groups were found for individual days.
    Comparison groups
    Treatment arm 2 v Treatment arm 3 v Treatment arm 4 v Treatment arm 1
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [42]
    P-value
    		 > 0.05
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [42] - A significantly higher proportion of subjects treated with Xenical® answered Yes to the question “Did you have a normal night’s sleep (about as long and as deep as usual)?” on Day 11, as compared to EMP16-01 90/30, when analysing the PPS population (p- value=0.046).

    Secondary: Meal pattern- main courses

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    End point title
    		 Meal pattern- main courses
    End point description
    Meal pattern was assessed using a short diet diary developed by Berteaus-Forslund et al. The questionnaire was completed by the subject three times per day.
    End point type
    Secondary
    End point timeframe
    At baseline and at the end of treatment
    End point values
    		 Treatment arm 1 Treatment arm 2 Treatment arm 3 Treatment arm 4
    Number of subjects analysed
    15 [43]
    17
    16
    14 [44]
    Units: Number of subjects
        Predose, bad meal pattern
    1
    0
    2
    3
        Predose, OK meal pattern
    3
    5
    4
    6
        Predose, good meal pattern
    13
    12
    10
    7
        Last day, bad meal pattern
    0
    0
    0
    0
        Last day, OK meal pattern
    2
    2
    5
    2
        Last day, good meal pattern
    13
    15
    11
    12
    Notes
    [43] - Pre dose: 17 subjects Last day: 15 subjects
    [44] - Pre dose: 16 subjects Last day: 14 subjects
    No statistical analyses for this end point

    Secondary: Meal pattern- light courses

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    End point title
    		 Meal pattern- light courses
    End point description
    Meal pattern was assessed using a short diet diary developed by Berteaus-Forslund et al. The questionnaire was completed by the subject three times per day.
    End point type
    Secondary
    End point timeframe
    At baseline and at the end of treatment
    End point values
    		 Treatment arm 1 Treatment arm 2 Treatment arm 3 Treatment arm 4
    Number of subjects analysed
    14 [45]
    15 [46]
    13 [47]
    13 [48]
    Units: Number of subjects
        Pre dose, bad meal pattern
    4
    1
    0
    1
        Pre dose, OK meal pattern
    2
    1
    1
    2
        Pre dose, good meal pattern
    11
    13
    15
    13
        Last day, bad meal pattern
    0
    0
    0
    0
        Last day, OK meal pattern
    0
    0
    0
    0
        Last day, good meal pattern
    14
    16
    13
    13
    Notes
    [45] - Pre dose: 17 subjects Last day: 14 subjects
    [46] - Pre dose: 15 subjects Last day: 16 subjects
    [47] - Pre dose: 16 subjects Last day: 13 subjects
    [48] - Pre dose: 16 subjects Last day: 13 subjects
    No statistical analyses for this end point

    Secondary: Meal pattern- snacks

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    End point title
    		 Meal pattern- snacks
    End point description
    Meal pattern was assessed using a short diet diary developed by Berteaus-Forslund et al. The questionnaire was completed by the subject three times per day.
    End point type
    Secondary
    End point timeframe
    At baseline and at the end of treatment
    End point values
    		 Treatment arm 1 Treatment arm 2 Treatment arm 3 Treatment arm 4
    Number of subjects analysed
    8 [49]
    11 [50]
    10 [51]
    7 [52]
    Units: Number of subjects
        Pre dose, bad meal pattern
    13
    10
    12
    8
        Pre dose, OK meal pattern
    1
    4
    0
    2
        Pre dose, good meal pattern
    1
    2
    2
    3
        Last day, bad meal pattern
    0
    0
    0
    0
        Last day, OK meal pattern
    6
    7
    5
    5
        Last day, good meal pattern
    2
    4
    5
    2
    Notes
    [49] - Pre dose: 15 subjects Last day: 8 subjects
    [50] - Pre dose: 16 subjects Last day: 11 subjects
    [51] - Pre dose: 14 subjects Last day: 10 subjects
    [52] - Pre dose: 13 subjects Last day: 7 subjects
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) were collected from signing the ICF until the follow-up assessment. Events occurring before first administration of IMP were defined as baseline events. Adverse Events occurring after first administration of IMP were defined as TEAEs.
    Adverse event reporting additional description
    AEs were spontaneously reported by the subjects and observed or elicited based on non-leading questions by the Investigator or medical personnel.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Treatment arm 1
    Reporting group description
    		 EMP16-01 60/20; 60 mg orlistat and 20 mg acarbose

    Reporting group title
    Treatment arm 2
    Reporting group description
    		 EMP16-01 90/30; 90 mg orlistat and 30 mg acarbose

    Reporting group title
    Treatment arm 3
    Reporting group description
    		 EMP16-01 120/40; 120 mg orlistat and 40 mg acarbose

    Reporting group title
    Treatment arm 4
    Reporting group description
    		 Xenical®; 120 mg orlistat

    Serious adverse events
    		 Treatment arm 1 Treatment arm 2 Treatment arm 3 Treatment arm 4
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Treatment arm 1 Treatment arm 2 Treatment arm 3 Treatment arm 4
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 17 (17.65%)
    7 / 17 (41.18%)
    11 / 16 (68.75%)
    11 / 17 (64.71%)
    Cardiac disorders
    Presyncope
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    0 / 17 (0.00%)
    3 / 17 (17.65%)
    3 / 16 (18.75%)
    3 / 17 (17.65%)
         occurrences all number
    0
    3
    3
    3
    Insomnia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abdominal pain
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    0
    1
    Faecal incontinence
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 17 (5.88%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Gingival pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Toothache
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Nasopharyngitis
         subjects affected / exposed
    2 / 17 (11.76%)
    4 / 17 (23.53%)
    6 / 16 (37.50%)
    2 / 17 (11.76%)
         occurrences all number
    2
    4
    6
    2
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Stress
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Depressed mood
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    0
    1
    Depression
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Sep 2016
    Subject replacement: To ensure the 12 evaluable subjects in each treatment arm required for the primary comparison, it was decided that subjects who prematurely discontinued participation and subjects for whom baseline PD samples on Day 14 were missing could be replaced. Randomization: A new randomization list was created for the extra subjects included based on the decision described in Section 9.8.1.1. The PD-related endpoints have been analysed both with and without the seven extra subjects included. Analysis of meal pattern: The following analyses were described in the Study Protocol: A mean value per day will be calculated using the total amount prior and after first dose. The actual values will be analysed using the Wilcoxon rank-sum test. The meal pattern variables will be presented using tables including summary statistics, actual and corrected p-value. During analysis, it was agreed between Sponsor and the statistician that the pre-planned analysis was not possible to perform. Instead, the total number of main courses, light courses and snacks at baseline (Day -1 to Day -3) and at the end of treatment (Day 13) should be categorised and presented as number and proportion of subjects in each category for each meal type.

    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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