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    Summary
    EudraCT Number:2006-006772-38
    Sponsor's Protocol Code Number:R256918OBE2001
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-09-26
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2006-006772-38
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study to Investigate the Safety and Efficacy of JNJ-16269110 in Overweight and Obese Subjects
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberR256918OBE2001
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorJanssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
    B.1.3.4CountryBelgium
    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 No
    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 nameJNJ-16269110/5-mg/capsules filled with beads
    D.3.2Product code F026
    D.3.4Pharmaceutical form Capsule, hard
    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.3.8INN - Proposed INNNot Assigned
    D.3.9.1CAS number 403989-79-7
    D.3.9.2Current sponsor codeJNJ-16269110-AAA
    D.3.9.3Other descriptive nameR256918
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 No
    D.3.11.8Extractive medicinal product No
    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.IMP: 2
    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 No
    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 nameJNJ-16269110/10-mg/capsules filled with beads
    D.3.2Product code F027
    D.3.4Pharmaceutical form Capsule, hard
    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.3.8INN - Proposed INNNot Assigned
    D.3.9.1CAS number 403989-79-7
    D.3.9.2Current sponsor codeJNJ-16269110-AAA
    D.3.9.3Other descriptive nameR256918
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    D.3.11.8Extractive medicinal product No
    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.IMP: 3
    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 No
    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 nameJNJ-16269110/15-mg/capsules filled with beads
    D.3.2Product code F028
    D.3.4Pharmaceutical form Capsule, hard
    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.3.8INN - Proposed INNNot Assigned
    D.3.9.1CAS number 403989-79-7
    D.3.9.2Current sponsor codeJNJ-16269110-AAA
    D.3.9.3Other descriptive nameR256918
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 No
    D.3.11.8Extractive medicinal product No
    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
    Obesity
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029883
    E.1.2Term Obesity
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to find the appropriate, clinically relevant dosages (among the 5, 10, and 15 mg twice-daily dosages) of JNJ-16269110 by assessing mean changes in body weight from baseline to Week 12, compared to placebo.
    E.2.2Secondary objectives of the trial
    To estimate the dose-response relationship between the different dosages of JNJ-16269110 and the decrease in body weight from baseline to Week 12
    To estimate the effect on weight loss of different JNJ-16269110 dosages versus placebo as expressed by mean percent change from baseline in body weight and in body mass index (BMI), and the percentage of subjects who lose at least 5% or 10% of their initial body weight
    To estimate changes in body composition using anthropometric measurements and by means of Dual X Ray Absorptiometry (DEXA [only at selected sites] to explore if weight loss is predominantly due to loss of fat mass
    To explore changes in obesity-associated comorbidities as assessed by glucose homeostasis, fasting lipid profile, and systolic and diastolic blood pressure
    To explore the effect of JNJ-16269110 on changes in levels of PYY, GLP 1, and oxyntomodulin



    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    FINAL: 07 August 2007 47
    • Men or women
    • Between 18 and 65 years of age, inclusive
    • Women must be:
    • postmenopausal, defined as having a last menstrual period at least
    1 year before screening with a serum follicle-stimulating hormone
    (FSH) level consistent with postmenopausal status
    • or surgically incapable of childbearing (have had a hysterectomy or
    bilateral oophorectomy or tubal ligation or otherwise incapable of
    pregnancy)
    • or if sexually active, be practicing an effective method of birth control
    (e.g. spermicide plus barrier, hormonal contraceptive, intrauterine
    device, or a partner with a vasectomy);
    • or sexually abstinent
    • Women of childbearing potential must be practicing an acceptable
    method of birth control (as previously defined) and have had a negative
    urine pregnancy test at screening as well as at the baseline visit before
    receiving study drug, which will be followed immediately by a serum
    beta-human chorionic gonadotropin (β-hCG) test. Subjects may be
    admitted to the study if the urine pregnancy test is negative, but will be
    discontinued immediately should the serum results be positive. Only a
    serum test is necessary at the end of the double-blind treatment phase.
    During the double-blind phase, a pregnancy test will be performed if
    pregnancy is suspected. Additional pregnancy tests may be performed at
    the discretion of the investigator.
    • Must be obese or overweight at screening (start of run-in period), defined
    as:
    • BMI ≥30 kg/m2 and <50 kg/m2 or
    • BMI ≥27 kg/m2 and <50 kg/m2 in the presence of controlled
    hypertension and/or treated or untreated dyslipidemia. For subjects
    receiving antihypertensive and/or hypolipidemic medications, these
    should have been at a stable dosage for at least 2 months before the
    start of the run-in period. There should be no anticipated changes to
    JNJ-16269110: Clinical Protocol R256918OBE2001
    antihypertensive or lipid-lowering medications during the course of the
    study.
    • Controlled hypertension is defined as a diastolic blood pressure
    <100 mmHg and a systolic blood pressure <160 mmHg, in the
    presence of antihypertensive drug treatment.22
    • For subjects who are not on lipid-lowering drugs, dyslipidemia is
    defined as LDL-C ≥3.4 mmol/L (130 mg/dL), HDL-C <1 mmol/L (40
    mg/dL) for men or <1.3 mmol/L (50 mg/dL) for women, or
    triglycerides ≥1.7 mmol/L (150 mg/dL).23
    • If subjects are clinically diagnosed with dyslipidemia as a result of
    screening assessments, they can only continue in the run-in phase of
    the study if in the clinical judgment of the investigator initiation of
    lipid-lowering therapy is not required either immediately or during the
    course of the study.
    • A stable weight, i.e., increasing or decreasing not more than 5 kg in the
    3 months before the start of the run-in period.
    • Consumption of breakfast and dinner on a daily basis
    • Ability to swallow the intact capsule (17.5 mm in length and 9.1 mm in
    diameter) with water, as judged by e.g. the subject's history of having no
    difficulty with swallowing e.g. capsules or intact tablets.
    • Fasting plasma glucose24 <7.0 mmol/L (126 mg/dL) at screening; in cases
    in which there is doubt concerning fasting conditions, a 1-time repeat of
    the fasting plasma glucose is allowed (fasting is defined as no caloric
    intake for at least 8 hours before the test)
    • Willing to adhere to the prohibitions and restrictions specified in this
    protocol
    • Subjects must have signed an informed consent document indicating that
    they understand the purpose of and procedures required for the study and
    are willing to participate in the study.
    • To participate in the optional pharmacogenomic component of this study,
    subjects (or their legally acceptable representative) must have signed the
    informed consent for pharmacogenomic research indicating willingness to
    participate in the pharmacogenomic component of the study (where local
    regulations permit). Subjects must also consent separately for blood
    samples for the future analysis of ALT isoforms. Refusal to consent for
    either component does not exclude a subject from participation in the
    clinical study.
    E.4Principal exclusion criteria
    FINAL: 07 August 2007 49
    • History of obesity with a known cause (e.g., Cushing’s disease)
    • History of anorexia nervosa, bulimia, or binge-eating disorder
    • An established diagnosis of diabetes mellitus or treatment with glucoselowering
    prescription drugs at screening
    • Prior exposure or known contraindication or hypersensitivity to
    JNJ-16269110
    • History of weight-reducing diet or receiving any drugs to treat obesity
    within the 3 months prior to screening
    • Treatment with any investigational drug or device within 1 month before
    the start of the run-in period
    • History or evidence of liver disease, including cirrhosis or nonalcoholic
    steatohepatitis/non-alcoholic fatty liver disease,
    • History of HIV or presence of hepatitis C antibodies or positive
    hepatitis B serology (refer to Attachment 2, Interpretation of Hepatitis B
    Results for Enrolling Subjects at screening)
    • History of clinically significant gastro-intestinal disease (including but
    not limited to gluten- and non-gluten-induced enteropathy, inflammatory
    bowel disease, malabsorption syndromes)
    • History of major gastro-intestinal surgery other than appendectomy or
    uncomplicated cholecystectomy.
    • Previous gastric restrictive surgery or other surgical procedures to induce
    weight loss
    • Liposuction within the last 3 months before screening
    • Pregnant or nursing women, or women who plan to become pregnant
    during the study
    • History of significant cardiovascular disease, including a history of
    myocardial infarction (MI), unstable angina and cerebrovascular accident
    (CVA) within 6 months of enrollment.
    • History of clinically significant cardiac valvular disease, or congestive
    heart failure (cardiovascular disability functional Class III-IV according
    to the New York Heart Association Classification of Cardiac Disease25;
    refer to Attachment 3)
    • 12-lead ECG showing evidence of clinically significant heart rhythm or
    conduction abnormality at screening or baseline.
    • An average of 3 seated readings where diastolic blood pressure
    ≥100 mmHg or a systolic blood pressure ≥160 mmHg at screening
    • Thyroid-stimulating hormone (TSH) >1.5 times ULN at screening.
    Subjects on medication for hypothyroidism should have been on a stable
    JNJ-16269110: Clinical Protocol R256918OBE2001
    FINAL: 07 August 2007 50
    dosage for at least 3 months before enrollment (the start of the run-in
    period).
    • A significant change in smoking habits within 3 months of the start of the
    run-in period; subjects planning to alter smoking habits during the course
    of the study
    • Malignancy or a history of a malignancy within 5 years before the start of
    the run-in period, other than basal cell carcinomas of the skin or in situ
    cervical carcinoma
    • History or evidence of clinically significant abnormal values for
    hematology, coagulation, or clinical biochemistry.
    • Increased liver function tests,
    • ALT above 1.5 X ULN
    • ALT above ULN but less than 1.5 X ULN with a concomitant increase
    of AST, bilirubin, alkaline phosphatase or LDH above 1.5 X ULN or
    GGT above 2x ULN at screening.
    • Increased creatinine kinase (CK) above ULN in subjects who take lipid
    lowering agents and CK level above 2 x ULN in subjects who do not take
    lipid lowering agents at screening visit.
    • Fasting TG >33.3 mmol/L (600 mg/dL) at screening. A 1-time repeat of
    the fasting triglycerides is allowed (fasting is defined as no caloric intake
    for at least 8 hours before the test)
    • Evidence of renal impairment (serum creatinine >133 µmol/L (1.5
    mg/dL) in men, >124 µmol/L (1.4 mg/dL) in women)
    • History of drug or alcohol abuse within the previous 2 years
    • Alcohol consumption exceeding 4 units per day for men or 3 units per day
    for women; 1 unit is defined as 330 mL beer, 100 mL wine, or 30 mL
    distilled spirits or the equivalent of this26
    • Receiving any excluded medication (refer to Section 8, Concomitant
    Therapy)
    • Any condition that in the opinion of the investigator would complicate or
    compromise the study, or the wellbeing of the subject

    • Women of childbearing potential must continue to practice an acceptable
    method of birth control.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the efficacy, safety and tolerability of JNJ-16269110
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    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.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 320
    F.4.2.2In the whole clinical trial 320
    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 Decision2007-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-22
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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