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    Clinical Trial Results:
    A randomized, subject- and investigator-blinded, placebo controlled pharmacodynamic study of oral LIK066 in overweight and obese women with polycystic ovary syndrome

    Summary
    EudraCT number
    		 2017-001373-16
    Trial protocol
    		 DE  
    Global end of trial date
    25 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Apr 2019
    First version publication date
    13 Apr 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CLIK066X2205
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03152591
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.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
    25 Jun 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to assess the treatment effect of LIK066 on hyperandrogenism at Day 15 in overweight and obese subjects with polycystic ovary syndrome (PCOS).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Jul 2017
    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
    Germany: 26
    Country: Number of subjects enrolled
    United States: 3
    Worldwide total number of subjects
    29
    EEA total number of subjects
    26
    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)
    29
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted in 5 centers in 2 countries: Germany (3), and USA (2).

    Pre-assignment
    Screening details
    		 Participants were randomized in the ratio of 1:1 to receive either LIK066 50 mg tid or placebo for 14 days and morning dose on Day 15.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LIK066
    Arm description
    		 LIK066 tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test
    Arm type
    		 Experimental

    Investigational medicinal product name
    LIK066
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects administered orally LIK066 50 mg tablets tid for 14 days and only one dose in the morning on Day 15.

    Arm title
    		 Placebo
    Arm description
    		 Placebo tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test
    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
    Subjects administered orally matching placebo tablets tid for 14 days and only one dose in the morning on Day 15.

    Number of subjects in period 1
    		LIK066 Placebo
    Started
    15
    14
    Pharmacokinetic (PK) analysis set
    14 [1]
    0 [2]
    Pharmacodynamic (PD) analysis set
    15
    14
    Completed
    15
    14
    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: 15 patients were enrolled into the LIK066 Treatment Arm; 14 of them were part of the PK analysis set; all 15 of them were included in the PD analysis set
    [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: PK analysis only performed in the LIK066 Treatment Arm

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LIK066
    Reporting group description
    		 LIK066 tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test

    Reporting group values
    		 LIK066 Placebo Total
    Number of subjects
    		 15 14 29
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 15 14 29
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 26.1 ( 4.76 ) 29.1 ( 5.66 ) -
    Sex/Gender, Customized
    Units: Subjects
        Female
    		 15 14 29
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 15 14 29
    Average fasting total testosterone
    Units: nmol/L
        arithmetic mean (standard deviation)
    		 1.98 ( 0.841 ) 2.07 ( 0.608 ) -
    Average fasting free testosterone
    Units: nmol/L
        arithmetic mean (standard deviation)
    		 0.037 ( 0.0163 ) 0.032 ( 0.0086 ) -
    Sex hormone binding globulin (SHBG)
    Units: nmol/L
        arithmetic mean (standard deviation)
    		 18.3 ( 7.72 ) 24.6 ( 10.51 ) -
    Free androgen Index
    Units: ratio
        arithmetic mean (standard deviation)
    		 12.4 ( 6.65 ) 9.0 ( 2.77 ) -

    End points

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    End points reporting groups
    Reporting group title
    LIK066
    Reporting group description
    		 LIK066 tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test

    Primary: Change in average morning fasting free testosterone blood concentrations from baseline

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    End point title
    		 Change in average morning fasting free testosterone blood concentrations from baseline
    End point description
    End point type
    Primary
    End point timeframe
    Baseline, Day 15
    End point values
    		 LIK066 Placebo
    Number of subjects analysed
    10
    10
    Units: nmol/L
        geometric mean (confidence interval 90%)
    0.91 (0.77 to 1.07)
    1.03 (0.88 to 1.21)
    Statistical analysis title
    		 Fasting free testosterone blood concentrations
    Comparison groups
    LIK066 v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.353
    Method
    		 t-test, 2-sided
    Parameter type
    		 Ratio LIK066/Placebo
    Point estimate
    0.88
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.11

    Secondary: Change from baseline in Luteinizing Hormone (LH) at Day 15

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    End point title
    		 Change from baseline in Luteinizing Hormone (LH) at Day 15
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Day 15
    End point values
    		 LIK066 Placebo
    Number of subjects analysed
    10
    10
    Units: U/L
        geometric mean (confidence interval 90%)
    1.37 (1.11 to 1.69)
    1.10 (0.89 to 1.36)
    Statistical analysis title
    		 Luteinizing Hormone (LH) at Day 15
    Comparison groups
    LIK066 v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.218
    Method
    		 t-test, 2-sided
    Parameter type
    		 Ratio LIK066/Placebo
    Point estimate
    1.25
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.68

    Secondary: Change from baseline in follicle stimulating hormone (FSH) at Day 15

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    End point title
    		 Change from baseline in follicle stimulating hormone (FSH) at Day 15
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Day 15
    End point values
    		 LIK066 Placebo
    Number of subjects analysed
    10
    10
    Units: U/L
        geometric mean (confidence interval 90%)
    1.13 (0.89 to 1.43)
    0.89 (0.70 to 1.13)
    Statistical analysis title
    		 Follicle stimulating hormone (FSH) at Day 15
    Comparison groups
    LIK066 v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.249
    Method
    		 t-test, 2-sided
    Parameter type
    		 Ratio LIK066/Placebo
    Point estimate
    1.27
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.78

    Secondary: Change from baseline in sex hormone binding globulin (SHBG) at Day 15

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    End point title
    		 Change from baseline in sex hormone binding globulin (SHBG) at Day 15
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Day 15
    End point values
    		 LIK066 Placebo
    Number of subjects analysed
    9
    10
    Units: nmol/L
        geometric mean (confidence interval 90%)
    1.06 (0.95 to 1.20)
    0.93 (0.83 to 1.03)
    Statistical analysis title
    		 Sex hormone binding globulin (SHBG) at Day 15
    Comparison groups
    LIK066 v Placebo
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.173
    Method
    		 t-test, 2-sided
    Parameter type
    		 Ratio LIK066/Placebo
    Point estimate
    1.15
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.36

    Secondary: Change from baseline in androstenedione at Day 15

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    End point title
    		 Change from baseline in androstenedione at Day 15
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Day 15
    End point values
    		 LIK066 Placebo
    Number of subjects analysed
    11
    12
    Units: nmol/L
        geometric mean (confidence interval 90%)
    0.85 (0.74 to 0.97)
    1.03 (0.91 to 1.17)
    Statistical analysis title
    		 Androstenedione at Day 15
    Comparison groups
    LIK066 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.089
    Method
    		 t-test, 2-sided
    Parameter type
    		 Ratio LIK066/Placebo
    Point estimate
    0.82
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 0.99

    Secondary: Change from baseline in dehydroepiandrostenedione (DHEA) at Day 15

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    End point title
    		 Change from baseline in dehydroepiandrostenedione (DHEA) at Day 15
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Day 15
    End point values
    		 LIK066 Placebo
    Number of subjects analysed
    11
    12
    Units: nmol/L
        geometric mean (confidence interval 90%)
    0.75 (0.58 to 0.98)
    1.09 (0.85 to 1.39)
    Statistical analysis title
    		 Dehydroepiandrostenedione (DHEA) at Day 15
    Comparison groups
    LIK066 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.109
    Method
    		 t-test, 2-sided
    Parameter type
    		 Ration LIK066/Placebo
    Point estimate
    0.69
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 1.01

    Secondary: Change from baseline in dehydroepiandrostenedione sulfate (DHEAS) at Day 15

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    End point title
    		 Change from baseline in dehydroepiandrostenedione sulfate (DHEAS) at Day 15
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Day 15
    End point values
    		 LIK066 Placebo
    Number of subjects analysed
    11
    12
    Units: umol/L
        geometric mean (confidence interval 90%)
    0.84 (0.75 to 0.94)
    1.10 (0.99 to 1.23)
    Statistical analysis title
    		 DHEAS at Day 15
    Comparison groups
    LIK066 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.008
    Method
    		 t-test, 2-sided
    Parameter type
    		 Ration LIK066/Placebo
    Point estimate
    0.76
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 0.89

    Secondary: Change from baseline in total testosterone at Day 15

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    End point title
    		 Change from baseline in total testosterone at Day 15
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Day 15
    End point values
    		 LIK066 Placebo
    Number of subjects analysed
    10
    10
    Units: nmol/L
        geometric mean (confidence interval 90%)
    0.95 (0.84 to 1.06)
    1.04 (0.92 to 1.17)
    Statistical analysis title
    		 Total testosterone at Day 15
    Comparison groups
    LIK066 v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.34
    Method
    		 t-test, 2-sided
    Parameter type
    		 Ratio LIK066/Placebo
    Point estimate
    0.91
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.07

    Secondary: Change from baseline in Free Androgen Index (FAI) at Day 15

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    End point title
    		 Change from baseline in Free Androgen Index (FAI) at Day 15
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Day 15
    End point values
    		 LIK066 Placebo
    Number of subjects analysed
    9
    10
    Units: 100x total testosterone/SHBG
        geometric mean (confidence interval 90%)
    0.85 (0.69 to 1.05)
    1.07 (0.88 to 1.31)
    Statistical analysis title
    		 Free Androgen Index (FAI) at Day 15
    Comparison groups
    LIK066 v Placebo
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.204
    Method
    		 t-test, 2-sided
    Parameter type
    		 Ratio LIK066/Placebo
    Point estimate
    0.79
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 1.08

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were collected for the maximum duration of participants' treatment exposure plus any follow up period, approximately 2 months.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    LIK066 50mg t.i.d.
    Reporting group description
    		 LIK066 50mg t.i.d.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 LIK066 50mg t.i.d. Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 LIK066 50mg t.i.d. Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 15 (100.00%)
    10 / 14 (71.43%)
    Investigations
    MENSTRUATION NORMAL
         subjects affected / exposed
    4 / 15 (26.67%)
    2 / 14 (14.29%)
         occurrences all number
    4
    2
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    4 / 15 (26.67%)
    1 / 14 (7.14%)
         occurrences all number
    4
    2
    MIGRAINE
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    THIRST
         subjects affected / exposed
    4 / 15 (26.67%)
    1 / 14 (7.14%)
         occurrences all number
    4
    1
    Gastrointestinal disorders
    ABDOMINAL DISTENSION
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    ABDOMINAL PAIN
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 14 (0.00%)
         occurrences all number
    4
    0
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    DIARRHOEA
         subjects affected / exposed
    15 / 15 (100.00%)
    3 / 14 (21.43%)
         occurrences all number
    16
    3
    DYSPEPSIA
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    FLATULENCE
         subjects affected / exposed
    6 / 15 (40.00%)
    0 / 14 (0.00%)
         occurrences all number
    6
    0
    GASTROINTESTINAL TRACT IRRITATION
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    NAUSEA
         subjects affected / exposed
    5 / 15 (33.33%)
    2 / 14 (14.29%)
         occurrences all number
    5
    2
    VOMITING
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    HYPOMENORRHOEA
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 14 (7.14%)
         occurrences all number
    2
    1
    MENSTRUAL DISORDER
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    DRY THROAT
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    RASH
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    INSOMNIA
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    MOOD ALTERED
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    POLYURIA
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    MUSCULOSKELETAL DISCOMFORT
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Infections and infestations
    NASOPHARYNGITIS
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 14 (7.14%)
         occurrences all number
    2
    1
    RHINITIS
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    VAGINAL INFECTION
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    VULVOVAGINAL MYCOTIC INFECTION
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Jul 2017
    Amendment 1 was issued to address comments received from the German Federal Institute for Drugs and Medical Devices (BfArM) and the Ethics Committee (EC) in the advice/information request letter following review of the clinical trial application (CTA). It • added text advising investigators to instruct the study subjects to watch for symptoms of ketoacidosis, hypoglycemia and hypotension • added risk of lower limb amputation • changed study treatment discontinuation criteria related to hypoglycemia and ketoacidosis • Changed stopping criteria related to hypoglycemia and ketoacidosis.
    29 Sep 2017
    Amendment 2 was issued to enable recruitment of the intended PCOS population with hyperandrogenism. The definition of hyperandrogenism was adjusted and the BMI cut off was removed. It included the following changes: • Biochemical hyperandrogenism was defined as free testosterone level that was approximately equal to or > 1.75× the ULN range of the assay used. • Overweight/obese subjects with BMI equal to or > 27 kg/m2, and stable weight ± 3 kg over previous 3 month (by history) were allowed to participate in the study. • The exclusion criterion for TSH was specified as, TSH levels > 10 uUI/ml and clinical symptoms of hypothyroidism. Subjects with sub clinical hypothyroidism need not be excluded. Subjects with well controlled on thyroid medication could be enrolled.

    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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