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    Summary
    EudraCT Number:2017-002407-10
    Sponsor's Protocol Code Number:17/0238
    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:2018-01-30
    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 number2017-002407-10
    A.3Full title of the trial
    A double-blinded, randomised, placebo-controlled trial of liraglutide 3.0 mg in patients with poor weight-loss and a suboptimal glucagon-like peptide-1 response following bariatric surgery.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Daily injection of liraglutide 3.0 mg versus placebo in patients with poor weight loss response and suboptimal blood level of a gut hormone that controls appetite called glucagon-like peptide-1 (GLP-1) following weight-loss surgery.
    A.3.2Name or abbreviated title of the trial where available
    BARI-OPTIMISE Version 1
    A.4.1Sponsor's protocol code number17/0238
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03341429
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1185-8283
    A.5.4Other Identifiers
    Name:UCL Data Protection Registration NumberNumber:Z6364106/2017/12/103
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity College London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNIHR
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportSir Jules Thorne Charitable Trust
    B.4.2CountryUnited Kingdom
    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 Yes
    D.2.1.1.1Trade name Saxenda
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameSaxenda
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLiraglutide
    D.3.9.1CAS number 204656-20-2
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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 in pre-filled pen
    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
    Obesity.
    E.1.1.1Medical condition in easily understood language
    The term obese describes a person who's very overweight. For the trial we will look at patients with poor weight loss after surgery and with suboptimal blood level of glucagon-like peptide-1 (GLP-1).
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10068900
    E.1.2Term Bariatric surgery
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029883
    E.1.2Term Obesity
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    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 this trial is to compare the efficacy of 24 weeks of subcutaneous liraglutide 3.0 mg versus placebo administration, as an adjunct to diet and exercise, on %WL in participants with poor weight-loss and a sub-optimal active GLP-1 response following primary RYGB or SG at the end of the 24-week treatment period.
    E.2.2Secondary objectives of the trial
    To compare the effect of 24-week subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise in participants with poor weight-loss and a sub-optimal active GLP-1 response following primary RYGB or SG, at the end of the 24-week treatment period, upon:
    1. Change in fat, lean body mass and bone density.
    2. Change in circulating fasted glucose, insulin, HbA1c and leptin, and meal-stimulated glycaemic index, gut hormones and appetite response.
    3. Change in HRQoL measures.
    4. Change in physical functional assessments and activity levels.
    5. Change in healthcare service usage.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients, 1 year or more after primary RYGB or primary SG, with poor weight-loss (<20% WL) that is not caused by either a surgical or psychological problem.
    2. Adults, 18-64 years inclusive.
    3. Suboptimal nutrient-stimulated GLP-1 response assessed by a meal test. Suboptimal active GLP-1 response is defined as a ≤2-fold increase in active GLP-1 circulating levels between time 0 and time 30 minutes.
    4. Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control, abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
    5. Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for trial treatment. NOTE: Subjects are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
    6. ≤5 % variation in body weight over preceding 3 months.
    7. Fluent in English and able to understand and complete questionnaires.
    8. Willing and able to provide written informed consent and comply with the trial protocol.
    E.4Principal exclusion criteria
    1. Had a surgical procedure other than gastric bypass and sleeve gastrectomy,or revision bariatric surgery of any operation type.
    2. Pregnant or lactating mothers.
    3. Participation in other clinical intervention trial.
    4. Lifetime history of suicidal behaviour or severe depression assessed by direct questioning.
    5. Clinically significant medical abnormalities (e.g., unstable hypertension, clinically significant ECG abnormalities, liver cirrhosis, AST or ALT > 3x the upper normal limit).
    6. Heart rate ≥ 100 beats/minute at screening on two separate measurements.
    7. Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
    8. Renal impairment (estimated glomerular infiltration rate (eGFR <30 ml/min 1.73 m2)
    9. Known or suspected hypersensitivity to liraglutide 3.0 mg and placebo or any of the excipients involved in their formulation.
    10. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
    11. Personal history of pancreatitis.
    12. Uncontrolled hypothyroidism or hyperthyroidism.
    13. History of stroke, unstable angina, acute coronary syndrome, congestive heart failure New York Heart Association class III-IV within the preceding 12 months.
    14. History of arrhythmias.
    15. Inflammatory bowel disease.
    16. Diabetic gastroparesis.
    17. Concomitant GLP-1 receptor agonist usage.
    18. Concomitant usage of medications that cause weight gain or weight loss.
    19. Concomitant usage of DPPIV-inhibitors.
    20. Insulin usage.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome of this trial is %WL from the baseline visit to the end of treatment visit at 24 weeks. Percentage weight loss will be calculated using the following formula: %WL = [(weight at the baseline visit – weight at the end of the 24-week treatment period)/ weight at the baseline visit] x 100, measured at the end of trial.
    E.5.1.1Timepoint(s) of evaluation of this end point
    There will be a single timepoint for the evaluation of the primary outcome corresponding to the end of treatment, i.e. week 24.
    E.5.2Secondary end point(s)
    The secondary outcomes of this trial are:
    1. To compare changes in fat (%), lean body mass (%) and bone density from baseline visit to end of 24-week treatment period, assessed using DXA scanning, between liraglutide 3.0 mg and placebo.
    2. To compare changes in circulating fasted glucose, insulin, HbA1c and leptin, and meal-stimulated glycaemic index, gut hormones and appetite response from baseline visit to end of 24-week treatment period between liraglutide 3.0 mg and placebo.
    3. To compare changes in HRQoL (aggregate scores) assessed using adapted CSRI, EQ-5D-3L, IWQOL-Lite and BDI from baseline visit to end of 24-week treatment period between liraglutide 3.0 mg and placebo.
    4. To compare changes in characteristics of attitude and symptom of depression (aggregate scores) assessed using BDI from baseline visit to end of 24-week treatment period between liraglutide 3.0 mg and placebo.
    5. To compare changes in physical fitness assessed using 6MWT (distance covered in m2), STS test (s) and handgrip test (kg) from baseline visit to end of 24-week treatment period between liraglutide 3.0 mg and placebo
    E.5.2.1Timepoint(s) of evaluation of this end point
    All of the above will be evaluated at baseline, at 4 follow-up visits (weeks 2, 4, 8 and 17) and at the end of treatment visit (week 24) for each participant.
    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 No
    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) 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The end of trial is 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 months7
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 70
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state70
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 70
    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)
    No study drug will be provided when participants complete their participation in the trial. Liraglutide is a licensed drug and should patients feel they would like to continue/start the treatment they will be advised to speak to their GP.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-11
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