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    Summary
    EudraCT Number:2007-000146-13
    Sponsor's Protocol Code Number:ATX-101-06-03
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-04-26
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-000146-13
    A.3Full title of the trial
    Phase 1-2, Multi-Centre, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) for the Reduction of Subcutaneous Fat in the Submental Area.
    A.3.2Name or abbreviated title of the trial where available
    Phase 1-2 study on ATX-101 for reduction of subcutaneous fat in the submental area
    A.4.1Sponsor's protocol code numberATX-101-06-03
    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 SponsorKythera Biopharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 nameATX-101
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 83-44-3
    D.3.9.2Current sponsor codeATX-101
    D.3.9.3Other descriptive nameSODIUM DEOXYCHOLATE
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Reduction of subcutaneous fat in the submental area
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety and tolerability of ATX-101 injections at three concentrations, relative to placebo.
    E.2.2Secondary objectives of the trial
    To evaluate the potential efficacy of ATX-101, relative to placebo, in reducing subcutaneous fat in the submental area.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Submental fat that is considered undesirable by the participant and graded by the Investigator as 2 or 3 using the SMF Rating Scale (Appendix C of the protocol).
    - Males or nonpregnant, nonlactating females who are aged 25 to 65 years, inclusive,
    on the date of randomization. Females of childbearing potential must have a negative human chorionic gonadotropin (HCG) test result within 28 days before randomization and must agree to practice adequate contraception, in the judgment of the investigator, during the course of the trial.
    - History of maintenance of a stable body weight, in the judgement of the Investigator, for at least 6 months before randomization.
    - The subject is expected to comply with and understand the visit schedule and all of the protocol-specified tests and procedures.
    - The subject is medically able to undergo the administration of study material as determined by clinical and laboratory evaluations (section 7.2 of the protocol) obtained within 28 days before randomization, for which the investigator identifies no clinically significant abnormality.
    - Signed informed consent obtained before any study specific procedure is conducted.
    E.4Principal exclusion criteria
    - History of any intervention to treat submental fat (e.g. liposuction) or trauma associated with the chin or neck areas, which in the judgment of the investigator, may affect safety or efficacy evaluation of the treatment.
    - Loose skin in the neck or chin area for which reduction in submental fat may, in the judgement of the Investigator, result in a cosmetically unacceptable outcome.
    - Prominent platysmal bands at rest that interfere with the evaluation of submental fat.
    - Evidence of any cause of enlargement in the submental area (eg. thyroid enlargement, cervical adenopathy) other than localised submental fat.
    - Fitzpatrick Skin Type IV, V, or VI (Appendix B of the protocol).
    - Currently on, or considering starting, a weight reduction regimen.
    - Any medical condition (e.g. respiratory, cardiovascular, hepatic, neurological disease, uncontrolled hypertension, thyroid dysfunction), that would interefere with the assessment of safety or efficacy in this trial or would compromise the ability of the subject to undergo study procedures or to give informed consent.
    - Treatment with fish oil or nonsteroidal anti-inflammatory agents (NSAIDs) within seven days before randomisation, or any anticipated need for agents with anticoagulative effects (e.g. warfarin, heparin) during the course of the trial. Aspirin used for prophylaxis will be allowed.
    - Treatment with oral anticoagulants (e.g. warfarin) within 28 days before randomisation.
    - Treatment with radio frequency, laser procedures, chemical peel, or dermal fillers in the neck or chin area within 12 months before randomization, or botulinum toxin injections within 6 months before randomization.
    - History of sensitivity to any components of the study material or to topical or local anaesthetics (e.g. lidocaine, benzocaine, novocaine).
    - Previous randomization into this trial.
    - Treatment with an investigational device or agent within 30 days before randomization.
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints include:
    - incidence, severity, and duration of all treatment-emergent adverse events
    - incidence of study material-related adverse events
    - severity and duration of study material-related adverse events
    - changes from baseline in clinical laboratory and urinalysis test results
    - changes from baseline in vital sign and weight measurements
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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 years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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) 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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 72
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Not applicable
    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 Decision2007-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-10-23
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