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    Clinical Trial Results:
    China multi-regional clinical trial: Efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes mellitus treated with diet and exercise only

    Summary
    EudraCT number
    		 2018-002590-22
    Trial protocol
    		 HU  
    Global end of trial date
    27 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Nov 2022
    First version publication date
    06 Nov 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN9924-4338
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04109547
    WHO universal trial number (UTN)
    		 U1111-1188-1173
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Alle, Bagsvaerd, Denmark, 2880
    Public contact
    Clinical Reporting Office (2834), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Clinical Reporting Office (2834), Novo Nordisk A/S, clinicaltrials@novonordisk.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
    17 Nov 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the effect of three once-daily dose levels of oral semaglutide (3, 7 and 14 mg) versus once-daily placebo on glycaemic control in subjects with T2D treated with diet and exercise only.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki, amended by the 64th WMA General Assembly October 2013 and ICH Good Clinical Practice, including archiving of essential documents, E6(R2), Step 4, 09 November 2016 and 21 CFR 312.120.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    01 Oct 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    China: 375
    Country: Number of subjects enrolled
    Hungary: 40
    Country: Number of subjects enrolled
    Serbia: 42
    Country: Number of subjects enrolled
    Taiwan: 15
    Country: Number of subjects enrolled
    Ukraine: 49
    Worldwide total number of subjects
    521
    EEA total number of subjects
    40
    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)
    448
    From 65 to 84 years
    73
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at 52 sites in 3 countries and Region China (China mainland and Taiwan) as follows: China mainland (37 sites), Taiwan (3 sites); Hungary (4 sites), Serbia (2 sites) and Ukraine (6 sites).

    Pre-assignment
    Screening details
    		 Total of 521 subjects with type 2 diabetes mellitus treated with diet and exercise only were randomized 1:1:1:1 to receive once-daily blinded treatment for 26 weeks with oral semaglutide 3, 7 or 14 milligrams (mg), or with placebo. The trial included a 4-week run-in period, a treatment period of 26 weeks and a 5-week follow-up period.

    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
    		 Investigator, Subject
    Blinding implementation details
    The trial was double-blinded and the clinical study group and the investigator remained blinded throughout the trial. The blinding was to be maintained until the database had been released for statistical analysis after the database lock.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Oral semaglutide 3 mg
    Arm description
    		 Subjects received oral semaglutide 3 mg tablets once daily from week 0 to week 26.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral semaglutide 3 mg tablets was administered once daily from week 0 to week 26. Semaglutide was administered daily in the morning in a fasting state and at least 30 minutes before the first meal of the day. Semaglutide was required to be taken with up to half a glass of water (approximately 120 mL/4 fluid oz) and was be swallowed whole and not broken or chewed.

    Arm title
    		 Oral semaglutide 7 mg
    Arm description
    		 Subjects received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral semaglutide tablets were administered once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26. Semaglutide was administered in the morning in a fasting state and at least 30 minutes before the first meal of the day. Semaglutide was required to be taken with up to half a glass of water (approximately 120 mL/4 fluid oz) and was be swallowed whole and not broken or chewed.

    Arm title
    		 Oral semaglutide 14 mg
    Arm description
    		 Subjects received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral semaglutide tablets were administered once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26. Semaglutide was administered in the morning in a fasting state and at least 30 minutes before the first meal of the day. Semaglutide was required to be taken with up to half a glass of water (approximately 120 mL/4 fluid oz) and was be swallowed whole and not broken or chewed.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received oral semaglutide matching placebo tablets once daily from week 0 to week 26.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral semaglutide matching placebo tablets were administered once daily from week 0 to week 26. Placebo was administered in the morning in a fasting state and at least 30 minutes before the first meal of the day. Placebo was required to be taken with up to half a glass of water (approximately 120 mL/4 fluid oz) and was be swallowed whole and not broken or chewed.

    Number of subjects in period 1
    		Oral semaglutide 3 mg Oral semaglutide 7 mg Oral semaglutide 14 mg Placebo
    Started
    130
    130
    130
    131
    Treated
    130
    130
    129
    131
    Full analysis set
    130
    130
    130
    131
    Safety analysis set
    130
    130
    129
    131
    Completed
    126
    126
    124
    124
    Not completed
    4
    4
    6
    7
         Consent withdrawn by subject
    3
    2
    6
    6
         Physician decision
    1
    2
    -
    -
         Lost to follow-up
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Oral semaglutide 3 mg
    Reporting group description
    		 Subjects received oral semaglutide 3 mg tablets once daily from week 0 to week 26.

    Reporting group title
    Oral semaglutide 7 mg
    Reporting group description
    		 Subjects received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26.

    Reporting group title
    Oral semaglutide 14 mg
    Reporting group description
    		 Subjects received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received oral semaglutide matching placebo tablets once daily from week 0 to week 26.

    Reporting group values
    		 Oral semaglutide 3 mg Oral semaglutide 7 mg Oral semaglutide 14 mg Placebo Total
    Number of subjects
    		 130 130 130 131 521
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    		 106 113 112 117 448
        From 65-84 years
    		 24 17 18 14 73
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54 ( 11 ) 52 ( 11 ) 53 ( 10 ) 51 ( 11 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 58 41 47 43 189
        Male
    		 72 89 83 88 332

    End points

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    End points reporting groups
    Reporting group title
    Oral semaglutide 3 mg
    Reporting group description
    		 Subjects received oral semaglutide 3 mg tablets once daily from week 0 to week 26.

    Reporting group title
    Oral semaglutide 7 mg
    Reporting group description
    		 Subjects received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26.

    Reporting group title
    Oral semaglutide 14 mg
    Reporting group description
    		 Subjects received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received oral semaglutide matching placebo tablets once daily from week 0 to week 26.

    Primary: Change in HbA1c

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    End point title
    		 Change in HbA1c
    End point description
    Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) at week 26 is presented. The endpoint data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Full analysis set included all randomized subjects. Number of Subjects Analysed = subjects with available data for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline (Week 0), Week 26
    End point values
    		 Oral semaglutide 3 mg Oral semaglutide 7 mg Oral semaglutide 14 mg Placebo
    Number of subjects analysed
    114
    117
    116
    106
    Units: Percentage of HbA1c
        arithmetic mean (standard deviation)
    -1.1 ( 0.7 )
    -1.5 ( 0.8 )
    -1.6 ( 1.0 )
    -0.2 ( 0.9 )
    Statistical analysis title
    		 Oral Semaglutide 14 mg, Placebo
    Comparison groups
    Oral semaglutide 14 mg v Placebo
    Number of subjects included in analysis
    222
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 MMRM
    Parameter type
    		 Treatment differene
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 -1.3
    Notes
    [1] - Unadjusted two-sided p-value for test of no difference from 0.
    Statistical analysis title
    		 Oral Semaglutide 7 mg, Placebo
    Comparison groups
    Oral semaglutide 7 mg v Placebo
    Number of subjects included in analysis
    223
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [2]
    Method
    		 MMRM
    Parameter type
    		 Treatment difference
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 -1.2
    Notes
    [2] - Unadjusted two-sided p-value for test of no difference from 0.
    Statistical analysis title
    		 Oral Semaglutide 3 mg, Placebo
    Comparison groups
    Oral semaglutide 3 mg v Placebo
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [3]
    Method
    		 MMRM
    Parameter type
    		 Treatment difference
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 -0.8
    Notes
    [3] - Unadjusted two-sided p-value for test of no difference from 0.

    Secondary: Change in body weight

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    End point title
    		 Change in body weight
    End point description
    Change from baseline (week 0) in body weight at week 26 is presented. The endpoint data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Full analysis set included all randomized subjects. Number of Subjects Analysed = subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Week 26
    End point values
    		 Oral semaglutide 3 mg Oral semaglutide 7 mg Oral semaglutide 14 mg Placebo
    Number of subjects analysed
    115
    119
    116
    106
    Units: Kilograms (kg)
        arithmetic mean (standard deviation)
    -1.1 ( 3.3 )
    -2.2 ( 3.4 )
    -3.1 ( 3.7 )
    -1.1 ( 2.7 )
    No statistical analyses for this end point

    Secondary: Change in fasting plasma glucose

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    End point title
    		 Change in fasting plasma glucose
    End point description
    Change from baseline (week 0) in fasting plasma glucose (FPG) at week 26 is presented. The endpoint data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Full analysis set included all randomized subjects. Number of Subjects Analysed = subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Week 26
    End point values
    		 Oral semaglutide 3 mg Oral semaglutide 7 mg Oral semaglutide 14 mg Placebo
    Number of subjects analysed
    114
    118
    116
    104
    Units: milligrams per decilitre (mg/dL)
        arithmetic mean (standard deviation)
    -19.07 ( 32.44 )
    -32.28 ( 27.95 )
    -32.50 ( 24.91 )
    0.00 ( 27.49 )
    No statistical analyses for this end point

    Secondary: If a subject achieves (yes/no) HbA1c below 7.0% (53 mmol/mol) (American Diabetes Association target)

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    End point title
    		 If a subject achieves (yes/no) HbA1c below 7.0% (53 mmol/mol) (American Diabetes Association target)
    End point description
    Number of subjects who achieved HbA1c < 7.0 % (53 millimoles per mole [mmol/mol]) (ADA target) at week 26 is presented. The endpoint data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Full analysis set included all randomized subjects. Number of Subjects Analysed = subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Oral semaglutide 3 mg Oral semaglutide 7 mg Oral semaglutide 14 mg Placebo
    Number of subjects analysed
    114
    117
    116
    106
    Units: Subjects
        Yes
    75
    100
    92
    27
        No
    39
    17
    24
    79
    No statistical analyses for this end point

    Secondary: Number of treatment-emergent adverse events during exposure to trial product

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    End point title
    		 Number of treatment-emergent adverse events during exposure to trial product
    End point description
    An adverse event (AE) is any untoward medical occurrence in a subject administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. Treatment-emergent adverse event (TEAE) was defined as an AE with onset in the on-treatment observation period. On-treatment observation period: from date of first dose of trial product following randomisation up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period. Safety analysis set included all subjects exposed to at least one dose of trial product.
    End point type
    Secondary
    End point timeframe
    Up to 31 weeks
    End point values
    		 Oral semaglutide 3 mg Oral semaglutide 7 mg Oral semaglutide 14 mg Placebo
    Number of subjects analysed
    130
    130
    129
    131
    Units: Events
        number (not applicable)
    251
    292
    231
    212
    No statistical analyses for this end point

    Secondary: Number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes during exposure to trial product

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    End point title
    		 Number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes during exposure to trial product
    End point description
    Severe or blood glucose (BG) confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose (PG) value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The endpoint data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomisation up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period. Safety analysis set included all subjects exposed to at least one dose of trial product.
    End point type
    Secondary
    End point timeframe
    Up to 31 weeks
    End point values
    		 Oral semaglutide 3 mg Oral semaglutide 7 mg Oral semaglutide 14 mg Placebo
    Number of subjects analysed
    130
    130
    129
    131
    Units: Episodes
        number (not applicable)
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From week 0 to week 31
    Adverse event reporting additional description
    All presented adverse events (AEs) are treatment-emergent (i.e., TEAEs). TEAE was defined as an AE with onset in the on-treatment observation period. Results are based on the safety analysis set (SAS) which included all subjects exposed to at least one dose of trial product.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Oral semaglutide 3 mg
    Reporting group description
    		 Subjects received oral semaglutide 3 mg tablets once daily from week 0 to week 26.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received oral semaglutide matching placebo tablets once daily from week 0 to week 26.

    Reporting group title
    Oral semaglutide 14 mg
    Reporting group description
    		 Subjects received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.

    Reporting group title
    Oral semaglutide 7 mg
    Reporting group description
    		 Subjects received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26.

    Serious adverse events
    		 Oral semaglutide 3 mg Placebo Oral semaglutide 14 mg Oral semaglutide 7 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 130 (4.62%)
    2 / 131 (1.53%)
    5 / 129 (3.88%)
    10 / 130 (7.69%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Papillary thyroid cancer
         subjects affected / exposed
    0 / 130 (0.00%)
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    0 / 130 (0.00%)
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nail injury
         subjects affected / exposed
    0 / 130 (0.00%)
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neck injury
         subjects affected / exposed
    1 / 130 (0.77%)
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 130 (0.77%)
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 130 (0.77%)
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 130 (0.77%)
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Splenic rupture
         subjects affected / exposed
    1 / 130 (0.77%)
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    1 / 130 (0.77%)
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    1 / 130 (0.77%)
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 130 (0.77%)
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    0 / 130 (0.00%)
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    0 / 130 (0.00%)
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 130 (0.00%)
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 130 (0.00%)
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 130 (0.00%)
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 130 (0.00%)
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 130 (0.00%)
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    2 / 130 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermal cyst
         subjects affected / exposed
    0 / 130 (0.00%)
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 130 (0.77%)
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 130 (0.00%)
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 130 (0.77%)
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    3 / 130 (2.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    0 / 130 (0.00%)
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Oral semaglutide 3 mg Placebo Oral semaglutide 14 mg Oral semaglutide 7 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 130 (23.08%)
    16 / 131 (12.21%)
    40 / 129 (31.01%)
    47 / 130 (36.15%)
    Investigations
    Lipase increased
         subjects affected / exposed
    7 / 130 (5.38%)
    0 / 131 (0.00%)
    4 / 129 (3.10%)
    11 / 130 (8.46%)
         occurrences all number
    12
    0
    4
    12
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 130 (0.77%)
    1 / 131 (0.76%)
    2 / 129 (1.55%)
    10 / 130 (7.69%)
         occurrences all number
    1
    1
    2
    13
    Constipation
         subjects affected / exposed
    1 / 130 (0.77%)
    0 / 131 (0.00%)
    3 / 129 (2.33%)
    7 / 130 (5.38%)
         occurrences all number
    1
    0
    3
    7
    Diarrhoea
         subjects affected / exposed
    4 / 130 (3.08%)
    2 / 131 (1.53%)
    12 / 129 (9.30%)
    12 / 130 (9.23%)
         occurrences all number
    4
    2
    18
    16
    Nausea
         subjects affected / exposed
    6 / 130 (4.62%)
    2 / 131 (1.53%)
    8 / 129 (6.20%)
    4 / 130 (3.08%)
         occurrences all number
    6
    2
    8
    4
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    11 / 130 (8.46%)
    6 / 131 (4.58%)
    9 / 129 (6.98%)
    12 / 130 (9.23%)
         occurrences all number
    12
    6
    12
    14
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 130 (1.54%)
    0 / 131 (0.00%)
    14 / 129 (10.85%)
    6 / 130 (4.62%)
         occurrences all number
    2
    0
    14
    7
    Hyperlipidaemia
         subjects affected / exposed
    4 / 130 (3.08%)
    7 / 131 (5.34%)
    1 / 129 (0.78%)
    3 / 130 (2.31%)
         occurrences all number
    4
    7
    1
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jan 2019
    Changes in trial design and Inclusion/Exclusion criteria. Addition of randomisation criterion. Update to statistical section and reduction of sample size.
    18 Apr 2019
    Country specific requirement was added to the inclusion criteria. The randomisation criterion was updated. Pharmacokinetics (PK) and antibody sample collection requirement was removed in all countries except China mainland. Changes to Anti-body analyses were made and Impact of Weight on Quality of Life-Lite (IWQoL-Lite) questionnaire was removed.

    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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