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    Summary
    EudraCT Number:2015-005163-16
    Sponsor's Protocol Code Number:U1111-1171-4970
    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:2016-03-02
    Trial 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 number2015-005163-16
    A.3Full title of the trial
    Effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis. A randomised, double blind, placebo-controlled, parallel group, single-centre trial
    Effekten af liraglutid på vægt og smerter blandt overvægtige patienter med slidgigt i knæ. Et dobbelt-blindet, placebokontrolleret, parallelgruppe lodtrækningsstudie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Liraglutide for obese patients with knee osteoarthritis
    Liraglutid til overvægtige patienter med slidgigt i knæet
    A.4.1Sponsor's protocol code numberU1111-1171-4970
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1171-4970
    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 SponsorThe Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark
    B.1.3.4CountryDenmark
    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 A/S
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Oak Foundation
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark
    B.5.2Functional name of contact pointPrimary/ Principal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressNordre Fasanvej 57, Vej 8, Indg. 19
    B.5.3.2Town/ cityFrederiksberg, Copenhagen
    B.5.3.3Post code2000
    B.5.3.4CountryDenmark
    B.5.4Telephone number4538164155
    B.5.5Fax number4538164159
    B.5.6E-mailhenrik.rindel.gudbergsen.01@regionh.dk
    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 CodeSUB25238
    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 Yes
    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
    Adult (≥ 18 years of age) overweight or obese patients (BMI ≥ 27 kg/m2 ) above 18 years of age with knee osteoarthritis (OA) defined by clinical diagnosis of knee OA according to the American College of Rheumatology (ACR) criteria confirmed by radiology but restricted to definite radiographic OA at early to moderate-stages (Kellgren-Lawrence grades 1, 2, or 3)
    E.1.1.1Medical condition in easily understood language
    Volunteer overweight or obese patients above 18 years of age with knee osteoarthritis (OA)
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10023476
    E.1.2Term Knee osteoarthritis
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10029885
    E.1.2Term Obesity, unspecified
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To establish the efficacy of a diet intervention combined with liraglutide 3 mg or liraglutide 3 mg placebo in inducing and maintaining weight loss over 52 weeks
    • To investigate the efficacy of a diet intervention combined with liraglutide 3 mg or liraglutide 3 mg placebo as a pain-reducing management strategy over 52 weeks
    E.2.2Secondary objectives of the trial
    • To compare the efficacy of a diet intervention combined with either liraglutide 3 mg or liraglutide 3 mg placebo for 52 weeks on knee OA-related patient reported stiffness and function scores
    • To compare the efficacy of a diet intervention combined with either liraglutide 3 mg or liraglutide 3 mg placebo for 52 weeks on intermittent and constant knee pain intensity, pain related distress, and the impact of OA pain on quality of life
    • To compare the efficacy of a diet intervention combined with either liraglutide 3 mg or liraglutide 3 mg placebo for 52 weeks on the proportion of patients loosing at least 5% or at least 10% of their body weight
    • To compare the efficacy of a diet intervention combined with either liraglutide 3 mg or liraglutide 3 mg placebo at week 52 on waist circumference, waist/hip ratio, and BMI
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1)
    Title:
    Observed and self-reported ADL ability in obese patients with knee OA: The benefit of weight loss and relations between observed and self-reported functional outcomes

    Objectives:
    To assess:
    • If weight loss in obese patients with knee OA is associated with improvements in observed and self-reported ADL ability.
    • The association between change in observed and self-reported ADL ability assessed by questionnaires and interview in obese patients with knee OA obtaining a significant weight loss (> 11%) is poor.

    2)
    Title:
    Biomarkers in obese patients with knee OA: The benefit of weight loss, patient reported outcomes, and biomarkers

    Objectives:
    It is intended to identify biomarkers according to the following specific objectives:
    1: To identify MicroRNA expression profiles as predictors of disease course and response to liraglutide (including adverse events)
    2: To identify DNA-profile and SNPs as predictors of disease course and response to liraglutide (including adverse events)
    3: To identify protein expression profiles as predictors of disease course and response to liraglutide (including adverse events)
    4: To identify metabolite expression profiles as predictors of disease course and response to liraglutide (including adverse events)

    3)
    Title:
    The association between weight loss and changes in physical activity in overweight/obese individuals with knee osteoarthritis: An observational cohort study

    Objectives:
    To describe changes in physical activity associated with a significant weight loss among overweight/obese individuals with knee OA.
    We hypothesize that weight loss is associated with a decrease in daily time spent physically inactive.

    4)
    Title:
    Multi-parametric imaging of knee osteoarthritis in obese patients with knee osteoarthritis; investigating the impact of inflammation in soft tissue and bone on clinical symptoms and cartilage.

    Objectives:
    1: To identify non-contrast and contrast enhanced MRI imaging markers of inflammation as predictors of disease course and clinical response to Liraglutide
    2: To identify imaging markers of inflammation as predictors of changes in cartilage health and response to Liraglutide
    3: To identify dual energy CT markers of crystal deposition disease in the soft tissue as predictors of disease course and clinical response to Liraglutide
    4: To identify ultrasound markers of inflammation as predictors of disease course and clinical response to Liraglutide

    The primary hypotheses are:
    1: Weight loss and Liraglutide will have a larger anti-inflammation effect, measured with MRI and ultrasound and thus a better clinical response, compared to weight loss and placebo
    2: Weight loss and Liraglutide will have and better cartilage protective effect measured by MRI, compared to weight loss and placebo
    E.3Principal inclusion criteria
    • Informed consent obtained
    • Clinical diagnosis of knee OA (American College of Rheumatology (ACR) criteria) confirmed by radiology but restricted to definite radiographic OA at early to moderate-stages (Kellgren-Lawrence grades 1, 2, or 3)
    • Age ≥ 18 years and < 75 years
    • Body mass index (BMI) ≥ 27 kg/m2
    • Stable body weight during the previous 3 months (< 5 kg self-reported weight change)
    • Motivated for weight loss
    E.4Principal exclusion criteria
    • On-going participation, or participation within the last 3 months, in an organised weight loss programme (or within the last 3 months)
    • Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial
    • Current use or use within three months before this trial of GLP-1 receptor agonist, pramlintide, sibutramine, orlistat, zonisamide, topiramate, or phentermine
    • Use of opioids or similar strong analgesics
    • Type 1 diabetes
    • Type 2 diabetes treated with glucose-lowering drugs other than metformin
    • Alloplasty in target knee joint (see section 6.3)
    • End stage disease in target knee joint (Kellgren-Lawrence grade 4)
    • Pregnancy or insufficient anti-conception therapy for female fertile patients
    • Breast-feeding
    • Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2
    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x above upper normal range (UNR)
    • Surgery scheduled for the trial duration period, except for minor surgical procedures
    • Surgical procedures such as arthroscopy or injections into a knee within 3 months prior to enrolment
    • Previous surgical treatment for obesity (excluding liposuction >1 year before trial entry)
    • Thyroid stimulating hormone (TSH) outside of the range of 0.4-6.0 mIU/L
    • Obesity secondary to endocrinologic or eating disorders or to treatment with medicinal products that may cause weight gain
    • Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
    • Inflammatory bowel disease
    • Congestive heart failure, New York Heart Association (NYHA) class III-IV
    • Diabetic gastroparesis
    • History of or current diagnosis of pancreatitis (acute and/or chronic) or pancreatic cancer
    • History of cancer with the exception of in-situ malignancies of the skin or cervix uteri
    • History of major depressive disorder, a PHQ-9 (Patient Health Questionnaire-9) score of more than 15, or a history of other severe psychiatric disorders or diagnosis of an eating disorder
    • Subjects with a lifetime history of a suicide attempt or history of any suicidal behaviour within the past month before entry into the trial
    • Inability to speak Danish fluently
    • A mental state impeding compliance with the program
    E.5 End points
    E.5.1Primary end point(s)
    In order to demonstrate that liraglutide 3 mg not only safely and efficaciously lowers body weight, but also reduce pain, these endpoints have been selected as co-primary.
    • Change in body weight
    Time frame; week 0 to 52
    • Change in the KOOS pain subscale
    Time frame; week 0 to 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 0 and 52
    E.5.2Secondary end point(s)
    Confirmatory secondary endpoints

    • Change in the KOOS symptom subscale
    Time frame; week 0 to 52
    • Change in the KOOS ADL subscale
    Time frame; week 0 to 52
    • Change in the KOOS sport and recreation subscale
    Time frame; week 0 to 52
    • Change in the KOOS health related QoL subscale
    Time frame; week 0 to 52
    • Change in the WOMAC pain subscale
    Time frame; week 0 to 52
    • Change in the WOMAC stiffness subscale
    Time frame; week 0 to 52
    • Change in the WOMAC function subscale
    Time frame; week 0 to 52
    • Change in total score and subscales in the ICOAP questionnaire
    Time frame; week 0 to 52
    • Proportion of participants with ≥5% weight loss
    Time frame; week 0 to 52
    • Proportion of participants with ≥10% weight loss
    Time frame; week 0 to 52
    • Change in BMI
    Time frame; week 0 to 52
    • Change in waist circumference and in waist/hip ratio
    Time frame; week 0 to 52

    Supportive secondary endpoints

    • Change in C-reactive protein (CRP), glycosylated haemoglobin (HbA1c), fasting plasma glucose (FPG), ALT, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides (TG), and total cholesterol (TC)
    Time frame; week 0 to 52
    • Change in resting heart rate and blood pressure
    Time frame; week 0 to 52
    • Change in the TRIM-weight questionnaire
    Time frame; week 0 to 52
    • Change in SF-36 total as well as mental and physical composite scores
    Time frame; week 0 to 52
    • Change in IWQoL-lite questionnaire
    Time frame; week 0 to 52
    • Proportion of participants responding according to the O-OA
    Time frame; week 0 to 52
    • Proportion of participants meeting metabolic syndrome criteria
    Time frame; week 0 to 52
    • Proportion of participants meeting pre-diabetes criteria
    Time frame; week 0 to 52

    Safety endpoints

    • Changes outside the reference limits (+/- 2 SD) in haemoglobin, thrombocytes, leucocytes, differential cell count, creatinine, and electrolytes
    Timing; at visits T0 as well as T15 or Tx
    • Changes outside the reference limits (+ 150 %) in ALT and CRP
    Timing; at visits T0 as well as T15 or Tx
    • Incidence of AEs
    Timing; at visits –T7 to T15 or Tx, and Tz
    • Incidence of suicidal behaviour and/or ideation, assessed by the C-SSRS
    Timing; at visits -Tx, T0 to T14, T15 or Tx, and Tz
    • Incidence of depression, assessed by the PHQ-9
    Timing; at visits -Tx, T0, T15 or Tx, and Tz
    • Incidence of patients with and without a binge eating disorder, assessed by the BES
    Timing; at visits T0, T15 or Tx, and Tz
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints: week 0 and 52

    Safety endpoints: week -8, -7, 0, 52, and 64
    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 No
    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 No
    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.8.5The 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 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
    Last patient last visit at week 64.
    Sidste patients sidste besøg ved uge 64.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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.1.2.1Number of subjects for this age range: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state150
    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)
    Will not be different from the expected normal treatment of that condition
    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 Decision2016-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-02-11
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