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    Summary
    EudraCT Number:2017-002998-20
    Sponsor's Protocol Code Number:UNOLE0626
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-05-15
    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 number2017-002998-20
    A.3Full title of the trial
    Effectiveness and cost of integrating a protocol with use of liraglutide 3.0mg into an obesity service (STRIVE Study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Saxenda in Obesity Services (STRIVE Study)
    A.3.2Name or abbreviated title of the trial where available
    STRIVE Study
    A.4.1Sponsor's protocol code numberUNOLE0626
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03036800
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1189-5726
    A.5.4Other Identifiers
    Name:RECNumber:17/NW/0517
    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 of Leicester
    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 supportNovo Nordisk
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Leicester
    B.5.2Functional name of contact pointProfessor Melanie Davies
    B.5.3 Address:
    B.5.3.1Street AddressDiabetes Research Centre (DRC), Leicester Diabetes Centre
    B.5.3.2Town/ cityLeicester General Hospital, Gwendolen Road
    B.5.3.3Post codeLE5 4PW
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0116 258 6481
    B.5.6E-mailmelanie.davies@uhl-tr.nhs.uk
    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
    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 Injection
    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 INNINN-Liraglutide (Saxenda 6 mg/mL solution for injection in pre -filled pen)
    D.3.9.1CAS number 204656-20-2
    D.3.9.3Other descriptive nameNN 2211
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.6mg to 3.0mg
    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) 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 No
    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
    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
    Obesity (overweight)
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    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
    The primary objective will be to compare the proportion of participants with severe and complicated obesity (defined as BMI ≥35 kg/m2 with at least one major obesity-related comorbidity) achieving weight loss ≥15% at 1 year (52 weeks) with a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care provided in Tier 3 services alone.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare the targeted prescribing pathway and standard care in terms of:
    1. improving obesity-related co-morbidities (obstructive sleep apnoea, prediabetes, diabetes, hypertension, dyslipidaemia, depression)
    2. referral rates to other obesity interventions
    3. long-term maintenance (defined as the proportion of participants maintaining weight loss of ≥15% at 104 weeks among those who achieved ≥15% weight loss at 52 weeks)
    4. budget impact on a Tier 3 weight management service
    5. long-term cost-effectiveness
    6. direct healthcare costs in terms of admissions, frequency, and cost of appointments
    7. safety-related outcomes
    8. adherence
    9. patient satisfaction.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be considered eligible to participate in this study, a patient must:
    • be aged between 18-75 years old (inclusive)
    • understand written and spoken English
    • be able to give informed consent
    • have a BMI ≥35 kg/m2
    • have been referred to the Tier 3 service in one of the participating sites
    • have a stable body weight (less than 5kg self-reported change during the previous 12 weeks)
    • have at least one of prediabetes, diabetes, hypertension, and/or obstructive sleep apnoea, as defined below:
    -prediabetes (defined as established diagnosis of impaired fasting glycaemia (IFG) from GP and/or established diagnosis of impaired glucose tolerance (IGT) from GP and/or HbA1C 42-47 mmol/mol (6-6.4%) without glucose lowering medications, at a blood test during the last 6 months)
    -diabetes (defined as established diagnosis of Type 2 diabetes from GP and/or HbA1C ≥48 mmol/mol (>6.5%) at a blood test during the last 6 months] and/or being treated with any combination of lifestyle, metformin, sulphonylureas, Thiazolidinediones (TZDs) or SGLT-2)
    -hypertension treated (defined as being on antihypertensive treatment with or without a diagnosis of hypertension from GP) or untreated (defined as Systolic Blood Pressure ≥140 mmHg at two consecutive visits at the Tier 3 clinic),
    -obstructive sleep apnoea (on CPAP or established diagnosis of Apnoea Hypopnoea Index ≥15 at sleep studies during the last 12 months).
    E.4Principal exclusion criteria
    Patients who have met any of the following criteria will be excluded from the study:
    • Diagnosis of Type 1 diabetes
    • T2DM with treatment on DPP-IV or insulin currently
    • Treatment with GLP-1 receptor agonists in the past or currently
    • Treatment with anti-obesity drugs within 12 weeks prior to randomisation
    • eGFR ≤30ml/min/1.73m2 on serum testing over the last 26 weeks
    • Females referred to the clinic because of fertility problem
    • Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using or willing to use adequate contraceptive methods (as described in Section 8.3.1
    • Have terminal illness
    • Are not primarily responsible for their own care
    • Any other significant disease or disorder which in the opinion of the investigator, may either put the participants at risk or may influence the result of the study or the participant’s ability to participate
    • Untreated or uncontrolled hypothyroidism/hyperthyroidism defined as thyroid-stimulating hormone >6 mIU/litre or <0.4 mIU/litre
    • Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
    • Personal history of non-familial medullary thyroid carcinoma
    • History of chronic pancreatitis or idiopathic acute pancreatitis
    • Amylase or lipase levels three times higher than the upper normal range
    • Obesity induced by other endocrinologic disorders (e.g. Cushing’s Syndrome)
    • Current or history of treatment with medications that may cause significant weight gain, within 12 weeks prior to randomisation, including systemic corticosteroids (except for a short course of treatment, i.e. 7−10 days), atypical antipsychotic and mood stabilizers (e.g. clozapine, olanzapine, valproic acid and its derivatives, and lithium)
    • Initiation of antidepressants during the last 12 weeks
    • Previous surgical treatment for obesity (excluding liposuction if performed >1 year before trial entry)
    • History of other severe psychiatric disorders
    • History of known or suspected abuse of alcohol and/or narcotics
    • History of major depressive episode during the last 2 years
    • Simultaneous participation in other clinical trials of investigational drugs, lifestyle or physical activity interventions. Patients will only be able to take part following participation in a previous clinical trial after a wash-out period of 16 weeks.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective will be to compare the proportion of participants with severe and complicated obesity (defined as BMI ≥35 kg/m2 with at least one major obesity-related comorbidity) achieving weight loss ≥15% at 1 year (52 weeks) with a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care provided in Tier 3 services alone.
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks after randomisation with the targeted use of LIRA 3mg in combination with standard care versus standard care alone in a Tier 3 service.

    104 weeks after randomisation to assess long term effects.
    E.5.2Secondary end point(s)
    The secondary objectives are to compare the targeted prescribing pathway and standard care in terms of:
    1. improving obesity-related co-morbidities (obstructive sleep apnoea, prediabetes, diabetes, hypertension, dyslipidaemia, depression)
    2. referral rates to other obesity interventions
    3. long-term maintenance (defined as the proportion of participants maintaining weight loss of ≥15% at 104 weeks among those who achieved ≥15% weight loss at 52 weeks)
    4. budget impact on a Tier 3 weight management service
    5. long-term cost-effectiveness
    6. direct healthcare costs in terms of admissions, frequency, and cost of appointments
    7. safety-related outcomes
    8. adherence
    9. patient satisfaction.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All the secondary outcomes will be assessed at one and two years.
    Blood tests: Screening, 32 ,52 and 104 weeks
    Questionnaires: Screening, 52 and 104 weeks
    Pregnancy Testing: Screening, Baseline, 8, 16, 20, 32, 40, 52, 65, 78, 91, 104 weeks (or as required).
    Weight/Waist Circumference: all visits (Screening - 104 weeks)
    Blood Pressure/heart rate (screening - 104 weeks)
    Change in medications (all Baseline-104 weeks)
    Medical History/Demographics (screening)
    Adherence to injections: (2- 104 weeks)
    Adherence to other obesity medications: (16, 32, 52 & 104 weeks)
    Adherence to Tier 3 service: (16, 32, 40, 52 & 104 weeks)
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Cost Effectiveness
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard care in Tier 3 specialist weigh management service
    E.8.2.4Number of treatment arms in the trial2
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days12
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days12
    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: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 114
    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 state304
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 384
    F.4.2.2In the whole clinical trial 384
    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)
    After the study, participants will be returned to the care of the weight management services where the local PI can make recommendations as to continuation with study treatment dependent on tolerance or side-effects.In case the GP or PI stops treatment or a participant withdraws from treatment with LIRA 3mg,the participant will be offered standard care and the observation will continue.
    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 Decision2017-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-29
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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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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