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    Summary
    EudraCT Number:2017-000082-72
    Sponsor's Protocol Code Number:RC-P0054
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-11-05
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-000082-72
    A.3Full title of the trial
    Study of the communication of the hypothalamus with the periphery: impact of metformin on leptin transport in the cerebrospinal fluid of obese patients. A monocentric prospective study
    Etude de la communication de l’hypothalamus avec la périphérie : impact de la Metformine sur le transport de la leptine dans le liquide cérébrospinal de patients obèses. Etude monocentrique, prospective
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of metformin on leptin in the cerebrospinal fluid of obese patients
    Impact de la Metformine sur la leptine dans le liquide cérébrospinal de patients obèses
    A.3.2Name or abbreviated title of the trial where available
    LEPTOB
    LEPTOB
    A.4.1Sponsor's protocol code numberRC-P0054
    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 SponsorGroupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)
    B.1.3.4CountryFrance
    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 supportCentre hospitalier d'Arras
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportSantélys
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportINSERM
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportFondation de l'Avenir
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportEuropean Research Council
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGHICL
    B.5.2Functional name of contact pointDRCI (Mélody PLETS)
    B.5.3 Address:
    B.5.3.1Street AddressRue du Grand But
    B.5.3.2Town/ cityLOMME
    B.5.3.3Post code59462
    B.5.3.4CountryFrance
    B.5.4Telephone number+33320225733
    B.5.5Fax number+33320225767
    B.5.6E-mailurm@ghicl.net
    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 Metformine Sandoz 500 mg
    D.2.1.1.2Name of the Marketing Authorisation holderSANDOZ
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameMetformine chlorhydrate
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNMETFORMIN HYDROCHLORIDE
    D.3.9.1CAS number 1115-70-4
    D.3.9.4EV Substance CodeSUB03200MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.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 Yes
    D.2.1.1.1Trade name METFORMINE ARROW 850
    D.2.1.1.2Name of the Marketing Authorisation holderARROW GENERIQUES
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameMetformine chlorhydrate
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNMETFORMIN HYDROCHLORIDE
    D.3.9.1CAS number 1115-70-4
    D.3.9.4EV Substance CodeSUB03200MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number850
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    OBESITY (BMI > 30)
    Obésité (IMC > 30)
    E.1.1.1Medical condition in easily understood language
    Obesity
    Obésité
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    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
    Study the impact of metformin in obese patients on blood and cerebrospinal fluid concentrations of leptin.
    Etudier l’impact de la metformine chez des patients obèses sur la leptinémie et la leptinorachie
    E.2.2Secondary objectives of the trial
    Study the impact of the metformine at obese patients on:
    1. Other molecules involved in the regulation of the food intake and in the axis "bowel-brain", during the migration of the signal leptin through tanycytes,
    2. Cerebral neurotransmitters involved in the regulation of the food intake,
    3. Of the travel of water molecules within the hypothalamus as well as the direction of these travels during a sequence MRI of distribution,
    4. Of the neurobiological and biochemical contents of the in vivo hypothalamus by spectroscopy RM,
    5. Anthropometric parameters,
    6. Of physical composition,
    7. Of energy expenditure
    8. Of the behavior and the food intake
    9. Parameters of the carbohydrate metabolism, lipid metabolism, hepatic metabolism
    10. Estimate safety of the metformin treatment
    Etudier l’impact de la metformine chez des patients obèses sur :
    1. D’autres molécules impliquées dans la régulation de la prise alimentaire et dans l’axe « intestin-cerveau », au cours de la migration du signal leptine au travers des tanycytes,
    2. Des neurotransmetteurs cérébraux impliqués dans la régulation de la prise alimentaire,
    3. Du déplacement des molécules d’eau au sein de l’hypothalamus ainsi que la direction de ces déplacements au cours d’une séquence IRM de diffusion,
    4. Du contenu neurobiologique et biochimique de l’hypothalamus in vivo par spectroscopie RM,
    5. Des paramètres anthropométriques,
    6. De composition corporelle,
    7. De dépense énergétique
    8. Du comportement et de prise alimentaire,
    9. Des paramètres du métabolisme glucidique, lipidique, hépatique,
    10. Evaluer la tolérance du traitement par metformine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female aged > = 18 and < = 40 years
    - Patient having an obesity with BMI > 30
    - Patient beneficiary of the French National Health Fund
    - Patient having agreed to take part in the study and having signed written consent form
    - Homme ou femme d’âge > ou = à 18 et < ou = à 40 ans
    - Présentant une obésité avec un IMC > 30
    - Patient affilié au régime de sécurité sociale
    - Patient ayant accepté de participer à l’étude et ayant signé le consentement
    E.4Principal exclusion criteria
    -Type 2 diabetes defined by 2 fasting blood glucose > 1,26 g/L or blood glucose > 2g/L at 120min of oral glucose tolerance test with 75g of glucose)
    - Glucose intolerance (fasting blood glucose between 1,10g/L and 1,26g/L or blood glucose between 1,40g/L and 2g/L at 120 minutes of oral glucose tolerance test with 75g of glucose)
    - Patients who are already treated with metformin
    - Type 1 diabetes
    - Active neoplastic pathology whose diagnosis is <5 years or under treatment
    - Neurological pathology (demyelinating, tumoral, vascular)
    - Pathology of adipose tissue (lipodystrophy)
    - History of bariatric surgery
    - Contraindication to metformin at the maximum dose
    - Contraindication to lumbar puncture
    - Contraindication to MRI
    - Obésité syndromique (d’origine génétique)
    - Diabète de type 2 (défini par 2 glycémies à jeun > à 1,26 g/L ou glycémie > 2g/L à 120min de l’HGPO à 75g de glucose)
    - Intolérance au glucose (glycémie à jeun entre 1,10g/L et 1,26g/L ou glycémie entre 1,40g/L et 2g/L à 120 minutes de l’HGPO à 75g de glucose)
    - Traitement par metformine déjà en place
    - Diabète de type 1
    - Pathologie néoplasique active, dont le diagnostic est < 5 ans, ou en cours de traitement
    - Pathologie neurologique (démyélinisante, tumorale, vasculaire)
    - Pathologie du tissu adipeux (lipodystrophie)
    - Antécédent de chirurgie bariatrique
    - Contre-indication à la metformine à dose maximale
    - Contre-indication à la ponction lombaire
    - Contre-indication à l’IRM
    E.5 End points
    E.5.1Primary end point(s)
    Ratio of cerebrospinal fluid (CSF) concentration of leptin to blood concentration of leptin
    Ratio leptinorachie/leptinémie à jeun
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 3 months
    A 3 mois
    E.5.2Secondary end point(s)
    1. Measure of the following ratios:
    a. CSF glucose / fasting blood glucose
    b. CSF GLP1 / fasting blood GLP1
    c. CSF insulin / fasting blood insulin
    d. CSF ghrelin/ fasting blood ghrelin

    2. Fasting plasma and CSF concentrations of :
    a. AgRP
    b. POMC
    c. PY
    d. soluble leptin receptor
    3. Apparent diffusion coefficient (ADC) obtained by diffusion MRI (performed on an empty stomach).
    4. Fasting hypothalamic metabolites concentrations measured by magnetic resonance spectroscopy :
    a. N-acetyl-aspartate NAA,
    b. Creatine Cr,
    c. Choline Cho.
    d. Glutamine / glutamate
    e. GABA
    5. Anthropometric parameters (weight, waist circumference),
    6. Body composition measured by bioelectrical impedance analysis in kg and % of fat mass, fat-free mass, and phase angle in degrees
    7. Energy expenditure measured by indirect calorimetry in kCal / 24h
    8. Eating Behavior questionnaires scores (TFEQ, DEBQ) balanced by a test of cognitive efficiency (MMSE) and dietary survey with food ingested in kCal/24h.
    9. Blood tests:
    a. Lipid levels (Total cholesterol, HDL cholesterol, LDL cholesterol, Triglycerides),
    b. Glucose levels (fasting blood glucose, glycated hemoglobin),
    c. Liver function values (AST, ALT, GGT, ALP).
    10. Safety of treatment measured using NCI-CTCAE v4.0 criteria (gastrointestinal disturbances (nausea, vomiting, diarrhea), skin reaction (erythema, pruritis, urticaria)).
    1. Mesure des ratios suivants :
    a. Glycorachie / glycémie à jeun,
    b. GLP1 LCS / GLP1 sérique à jeun,
    c. Insuline LCS / insuline sérique à jeun,
    d. Ghréline LCS / ghréline sérique à jeun.
    2. des concentrations plasmatiques et dans le LCS à jeun en:
    a. AgRP
    b. POMC
    c. PY
    d. récepteur soluble de la leptine
    3. Du coefficient de Diffusion Apparent (ADC) obtenu par IRM de diffusion à jeun.
    4. Des concentrations par Spectroscopie par Résonnance Magnétique à jeun en métabolites hypothalamiques :
    a. N Acétyl Aspartate NAA,
    b. Créatine Cr,
    c. Choline Cho.
    d. Glutamine / glutamate
    e. GABA
    5.des paramètres anthropométriques (poids, périmètre abdominal),
    6.de la composition corporelle mesurée par impédancemétrie bioélectrique en kg et % de masse grasse et masse non grasse ainsi que l’angle de phase en degrés,
    7. de la dépense énergétique mesurée par calorimétrie indirecte en kCal / 24h
    8. Des scores sur questionnaire de comportement alimentaire (TFEQ; DEBQ) pondéré par un test d’efficience cognitive (MMSE) et enquête alimentaire avec ingestas en kCal/24h.
    9. Des bilans :
    a. Lipidique (Cholestérol total, HDL cholestérol, LDL cholestérol, Triglycérides),
    b. glucidique (glycémie à jeun, hémoglobine glyquée),
    c. Hépatique (TGO, TGP, GGT, Palc).
    10. Tolérance traitement : évaluée selon l’échelle de toxicité NCI-CTC-AE v4.0 (gastro-intestinaux (nausées, vomissements, diarrhées), réaction cutanée (érythème, prurit, urticaire)).
    E.5.2.1Timepoint(s) of evaluation of this end point
    At Month 0 and month 3
    à l'inclusion et au 3ème mois
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Obesity physiopathology
    Physiopathologie de l'obésité
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    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 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
    dernière visite du dernier patient inclus
    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 days15
    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: 31
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state31
    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)
    None
    Aucune
    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 Decision2019-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2024-04-11
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