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    Summary
    EudraCT Number:2005-001558-26
    Sponsor's Protocol Code Number:ADG103440
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-09-19
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2005-001558-26
    A.3Full title of the trial
    A RANDOMISED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED, MULTICENTRE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFICACY OF ORAL GW677954 CAPSULES 2.5mg, 5mg, 10mg AND 20mg A DAY FOR WEEKS IN OVERWEIGHT DYSLIPIDAEMIC SUBJECTS
    A.4.1Sponsor's protocol code numberADG103440
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGW677954
    D.3.2Product code GW677954
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeGW625019
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5, 5, 10, 20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Overweight Dyslipidaemic Subjects
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level LLT
    E.1.2Classification code 10052066
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effect of GW677954 at doses of 2.5mg, 5mg, 10mg and 20mg with those of placebo on non-HDL-C at 24 weeks in overweight subjects with low HDL-C, high TGs dyslipidaemia.
    E.2.2Secondary objectives of the trial
    To evaluate temporal changes in PD glycemic parameters,effect on fasting insulin and C-peptide levels,and on measures of insulin resistance through homeostasis model resulting from administering a range of doses of GW677954(±metformin) in subjects with T2DM.
    To investigate the effects of a range of doses of GW677954(± metformin) versus placebo(± metformin) on lipid parameters.
    To characterize the population PK of GW677954(± metformin).
    To characterize the safety profile of GW677954 To investigate the effects of a range of doses of GW677954 (± metformin) versus placebo (± metformin) on biomarkers of fluid retention, cardiovascular risk, systemic inflammation, and insulin sensitivity.
    To characterise the safety and tolerability of GW677954 at doses of 2.5mg, 5mg,10mg and 20mg and compare with that of placebo through assessment of physical examination, vital signs, clinical laboratory tests, ophthalmic assessments and AE reporting.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Waist circumference ≥102cm (men) or ≥88cm (women) at visit 1
    2. Fasting plasma HDL-C ≤40mg/dL (1.03mmol/L) (men) or ≤50mg/dL (1.29mmol/L)
    (women) at Screening Visit 1
    3. Fasting TGs ≥150mg/dL (1.69mmol/L) and ≤800mg/dL (8.96mmol/L) at Screening
    Visit 1
    4. Subjects whose plasma LDL-C concentration does not require treatment according to the NCEP ATP III guidelines at Screening Visit 1
    • Plasma LDL-C concentration ≤190mg/dL (≤4.91mmol/L) if no more than one
    cardiovascular risk factor, or
    • Plasma LDL-C concentration ≤160mg/dL (≤4.13mmol/L) if two or more
    cardiovascular risk factors, and a 10-year congestive heart failure (CHF) risk
    ≤10% (Framingham Point Scores), or
    • Plasma LDL-C concentration ≤130mg/dL (≤3.36mmol/L) if two or more
    cardiovascular risk factors, and a 10-year CHF risk >10% and ≤20%
    (Framingham Point Scores).
    5. Male and female subjects 18 to 70 years of age (inclusive at the time of Screening) at Visit 2
    6. Females, to be eligible to enter and participate in this study must be:
    either, of non-childbearing potential (i.e., physiologically incapable of becoming pregnant (tubal ligation), including any female who is post-menopausal [>1 year without menstrual period]); or, of child-bearing potential and have a negative pregnancy test at Screening (serum), and: have a male partner who is sterile prior to the female subject’s entry into the study and is the sole sexual partner for that female subject, or use double-barrier methods of contraception; condoms with the use of caps (with spermicide) and intrauterine devices are acceptable, or use hormonal contraceptives (oral, depots, patches, etc) with double-barrier methods of contraception as outlined above, or abstain from sexual intercourse, or be with a same sex partner and does not participate in bisexual activities where there
    is any risk of pregnancy.
    7. Subject has given full written informed consent prior to any study-related procedures are performed.
    8. If subject is a smoker, must be able to abstain while in clinic at each visit.
    E.4Principal exclusion criteria
    1. Metabolic Disease including:
    • Diagnosis of Type 1 or Type 2 diabetes mellitus, or FPG at Screening, and at Visit 2 both >126mg/dL (>7.0mmol/L);
    • Uncorrected thyroid dysfunction;
    • Significant weight gain or loss within the 3 months prior to Screening (Visit 1).
    2. History of recent clinically significant cardiovascular disease at Visit 2 including:
    • History or ECG evidence of prior myocardial infarction
    • Current unstable angina or history of unstable angina
    • Coronary revascularization including percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery that is either planned or occurred in the 6 months prior to Screening.
    • Clinically significant arrhythmia or valvular heart disease.
    • Congestive heart failure with NYHA Class II-IV symptoms.
    • Blood pressure > 160/100 mmHg or resting heart rate > 100 bpm at Visit 2.
    • Has a QTc interval > 440 msec in males and > 450 msec in females at Visit 2
    • Clinically significant ECG abnormalities
    3. History of chronic pancreatitis;
    4. Diagnosis of either Familial hypercholesterolaemia or Familial combined hyperlipidaemia
    5. History of TGs in excess of 800mg/dL (8.96mmol/L)
    6. Serum creatinine at visit 2 > 1.4 mg/dL (124µmol/L) for women, or > 1.5mg/dL
    (133µmol/L) for men at visit 2.
    7. Clinically significant anaemia defined by haemoglobin concentration <12.0g/dL or
    <120.0g/L for males and <11.0g/dL or <110.0g/L for females at Visit 2
    8. Documented history of hepato-biliary disease including a history of, or positive
    laboratory results for hepatitis (hepatitis B surface antigen, hepatitis B core antigen,
    and/or hepatitis C antibody) at Run-in [Visit 2], and/or clinically significant hepatic
    enzyme elevation including:
    • Any one of the following enzymes greater than 2.5 times the ULN value:
    - Alanine aminotransferase
    - Aspartate aminotransferase
    - Alkaline phosphatase
    • Total or direct bilirubin >1.5 x ULN, unless due to diagnosed or presumed Gilbert’s disease.
    9. History of metabolic acidosis or rhabdomyolysis, or a history of myalgia, myositis or
    myopathy after taking statins and/or fibrates.
    10. Signs or symptoms of myositis and/or CK >3 x ULN at Screening;
    11. Is currently taking or has taken any of the following medications in the 3 months
    prior to Screening (Visit 1) as assessed at visit 2:
    • All lipid-lowering agents and drugs known to have substantial effect on lipid
    metabolism
    • All oral glucose-lowering agents and insulin
    • Anti-obesity agents
    • Warfarin and digoxin
    • Oral or injectable corticosteroids (other than inhaled, intranasal and topical)
    • Oral anti-coagulant (other than aspirin, clopidogrel and non-steroidal
    anti-inflammatory drugs [NSAIDs])
    • Antiretroviral drugs
    • St. John’s Wort
    • Use of TZDs in the 3 months prior to the screening
    • Methotrexate, cyclosporine or monoclonal antibodies
    • Atypical antipsychotics medications
    • Monoamine oxidase inhibitors
    12. History of cancer
    13. Women who are lactating, pregnant, or planning to become pregnant.
    14. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to any drug
    chemically related to the study drug.
    15. Known allergy to any of the capsule excipients, or history of drug or other allergy,
    which, in the opinion of the responsible study physician, contradicts participation.
    16. Has a history of substance abuse within the past year as determined by the
    Investigator at (Visit 2) or during treatment:
    • Unwilling to refrain from the use of illicit drugs and adhere to other protocolstated
    restrictions while participating in the study.
    • History of alcohol abuse defined as an average weekly intake of greater than
    21 units or an average daily intake of greater than 3 units (males) or defined as
    an average weekly intake of greater than 14 units or an average of daily intake
    of greater than 2 units (females).
    17. Received treatment with the investigational product during the previous 4 months or any other trial during the previous 3 months, or has participated in a previous study with GW677954.
    18. Subjects with ongoing oedema or history of oedema requiring pharmacological
    treatment in the 3 months prior to Screening (Visit 1) as assessed at Visit 2
    19. Subjects who have a history of adverse events after taking a PPARγ or a PPARαγ
    agonist.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage change from baseline in non-HDL-C based on log-transformed data at
    week 24.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    databaze freeze, expected date 16 February 2006
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months16
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months16
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 145
    F.4.2.2In the whole clinical trial 290
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2005-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-11-16
    P. End of Trial
    P.End of Trial StatusCompleted
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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
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