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    Summary
    EudraCT Number:2020-003296-18
    Sponsor's Protocol Code Number:LDX0119
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-003296-18
    A.3Full title of the trial
    Effect of oral ladarixin 400 mg twice a day on insulin sensitivity. A phase 2, randomized, double-blind, placebo-controlled explorative study in obese patients with pre-diabetes eligible to bariatric surgery.
    Effetto di ladarixin somministrato per via orale alla dose di 400mg due volte al giorno sulla sensibilità all’insulina. Studio di fase 2, esplorativo, randomizzato, in doppio cieco, controllato verso placebo, in pazienti obesi con pre-diabete candidati alla chirurgia bariatrica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of the experimental drug ladarixin administered orally at a dose of 400 mg twice a day on insulin sensitivity. A phase 2, randomized, double-blind, placebo-controlled explorative study in obese patients with pre-diabetes eligible to bariatric surgery.
    Effetto del farmaco sperimentale ladarixin somministrato per via orale alla dose di 400mg due volte al giorno sulla sensibilità all’insulina. Studio di fase 2, esplorativo, randomizzato, in doppio cieco, controllato verso placebo, in pazienti obesi con pre-diabete candidati alla chirurgia bariatrica.
    A.3.2Name or abbreviated title of the trial where available
    Ladarixin in obese pre-diabetic patients eligible to bariatric surgery
    Ladarixin nei pazienti obesi con pre-diabete candidati alla chirurgia bariatrica
    A.4.1Sponsor's protocol code numberLDX0119
    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 SponsorDOMPé FARMACEUTICI S.P.A.
    B.1.3.4CountryItaly
    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 supportDompè farmaceutici spa
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCROS NT Srl
    B.5.2Functional name of contact pointClinical Department
    B.5.3 Address:
    B.5.3.1Street Addressvia Germania, 2
    B.5.3.2Town/ cityVerona
    B.5.3.3Post code37136
    B.5.3.4CountryItaly
    B.5.4Telephone number04582026666
    B.5.5Fax number0458205875
    B.5.6E-mailalessia.sandri@crosnt.com
    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 nameLadarixin
    D.3.2Product code [Ladarixin]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLadarixin
    D.3.9.1CAS number 865625-56-5
    D.3.9.2Current sponsor codeDF 2156A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Obesity and pre-diabetes
    Obesità e pre-diabete
    E.1.1.1Medical condition in easily understood language
    A medical condition characterized by excessive accumulation of body fat and blood glucose level above the normal value, but not yet in the diabetic range
    Condizione medica caratterizzata da un eccessivo accumulo di grasso corporeo e livelli di glucosio nel sangue superiori alla norma, ma non ancora nel range del diabete
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10036481
    E.1.2Term Pre-diabetes
    E.1.2System Organ Class 100000004861
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10065542
    E.1.2Term Prediabetes
    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
    The main objective is to explore whether ladarixin may improve insulin sensitivity in patients with pre-diabetes eligible to bariatric surgery due to obesity. The safety of ladarixin in the specific clinical setting will be also evaluated.
    L'obiettivo principale è esplorare se ladarixin può migliorare la sensibilità all'insulina nei pazienti con pre-diabete idonei alla chirurgia bariatrica a causa dell'obesità. Verrà inoltre valutata la sicurezza di ladarixin nello specifico contesto clinico.
    E.2.2Secondary objectives of the trial
    not applicable
    non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male and female patients aged 30-65 years, inclusive;
    - Body Mass Index (BMI) >35 kg/m2;
    - Presence of pre-diabetes (fasting glucose 100-125 mg/dL, inclusive; HbA1c 5.7-6.5%, inclusive);
    - Eligible to bariatric surgery as per any other criteria dictated by the Surgery Units;
    - Patients who have given written informed consent prior of any study-related procedure not part of standard medical care;
    - Patients able to comply with all protocol procedures for the duration of the study, including scheduled follow-up visits and examinations.
    - Pazienti maschi e femmine di età compresa tra 30 e 65 anni inclusi;
    - Indice di massa corporea (BMI) >35 kg/m2;
    - Presenza di pre-diabete (glucosio a digiuno 100-125 mg/dL, incluso; HbA1c 5,7-6,5%, incluso);
    - Idoneo alla chirurgia bariatrica secondo eventuali altri criteri dettati dalle Unità di Chirurgia;
    - Pazienti che hanno fornito il consenso informato scritto prima di qualsiasi procedura correlata allo studio non facente parte delle cure mediche standard;
    - Pazienti in grado di attenersi a tutte le procedure del protocollo per la durata dello studio, comprese le visite di follow-up e gli esami programmati.
    E.4Principal exclusion criteria
    - Moderate to severe renal impairment (creatinine clearance (CLcr) <60 mL/min);
    - Hepatic dysfunction (defined by increased ALT/AST >3 x upper limit of normal and increased total bilirubin >3 mg/dL [>51.3 µmol/L]);
    - Hypoalbuminemia (serum albumin <3 g/dL);
    - QTcF >470 msec;
    - History of any past or current clinically significant cardiovascular disease/abnormality;
    - Known hypersensitivity to non-steroidal antiinflammatory drugs;
    - Presence of any other clinical condition/disease that the PI believes might compromise patient’s safety or otherwise confound study outcome;
    - Patients on treatment with phenytoin, warfarin, sulphanylurea hypoglycemics and high dose of amitriptyline (>50 mg/day);
    - Previous (within 2 weeks prior to randomization) treatment with any medications known to influence glucose tolerance
    - Pregnant or breast feeding women. Unwillingness to use effective contraceptive measures up to 2 months after the end of study drug administration (females and males).
    - Insufficienza renale da moderata a grave (clearance della creatinina (CrCl) <60 mL/min);
    - Disfunzione epatica (ALT/AST superiori di tre volte il limite superiore di normalità e bilirubina totale >3 mg/dL [>51.3 µmol/L]);
    - Ipoalbuminemia (albumina serica < 3 g/dL);
    - QTcF >470 msec;
    - Storia di qualsiasi malattia/anormalità cardiovascolare clinicamente significativa passata o attuale;
    - nota ipersensibilità ai farmaci antinfiammatori non steroidei;
    - Presenza di qualsiasi altra condizione/malattia clinica che l'IP ritiene possa compromettere la sicurezza del paziente o altrimenti confondere i risultati dello studio;
    - Pazienti in trattamento con farmaco con stretta finestra terapeutica metabolizzati dal citocromo CYP2C9;
    - Pazienti in trattamento con con insulina o qualsiasi ipoglicemizzante orale o altro farmaco di cui sia nota la capacità di influenzare la tolleranza al glucosio;
    - Saranno anche escluse le donne in stato di gravidanza o durante l’allattamento e donne e uomini che non desiderano utilizzare un metodo efficace di contraccezione.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Endpoints:
    • Insulin Sensitivity Index-Matsuda (ISI-M) from 3h-(OGTT)
    • Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
    • C-peptide AUC from 3h-OGTT
    • Proinsulin : C-peptide ratio
    • Proportion of patients with Impaired Glucose Tolerance (IGT)
    • Hormones (adipokine, incretines, etc.)
    • Inflammatory chemokines/cytokines and CRP
    • Gut (faeces) microbiome/microbiota “Diversity”
    • Abdominal obesity (waist and waist/hip circumference)
    • Adipocyte characterization (exploratory endpoint)
    Safety Endpoints:
    • Blood pressure and heart rate
    • Safety laboratory tests [haematology (haematocrit, haemoglobin, red blood cells, platelets, white blood cells, differential white blood cells count) and clinical chemistry (sodium, potassium, serum creatinine, serum albumin, total bilirubin, ALT, AST)]
    • Incidence of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
    Endpoint di efficacia:
    • Indice di sensibilità all'insulina secondo Matsuda (ISI-M) derivato dall’OGTT di 3 ore
    • Modello di valutazione all'omeostasi della resistenza all'insulina (HOMA-IR)
    • AUC del C-peptide derivato dall'OGTT di 3 ore
    • Rapporto Proinsulina: C-peptide
    • Proporzione di pazienti con alterata tolleranza al glucosio (IGT)
    • Ormoni (adipochine, incretine, ecc)
    • Chemochine/citochine infiammatorie e CRP
    • Profilo del microbioma/microbiota intestinale (feci)
    • Obesità addominale (circonferenza alla vita e rapporto circonferenza vita/fianchi)
    • Caratterizzazione degli adipociti (variabile di tipo esplorativo)
    Endpoint di sicurezza:
    • Pressione sanguigna e frequenza cardiaca
    • “Parametri ematici di sicurezza” [ematologia (ematocrito, emoglobina, eritrociti, piastrine, globuli bianchi, conta differenziale dei globuli bianchi) e biochimica (sodio, potassio, creatinina serica, albumina serica, bilirubina totale, ALT, AST)];
    • Incidenza degli eventi avversi emergenti dal trattamento (TEAE) e degli eventi avversi gravi emergenti dal trattamento (TESAE)
    E.5.1.1Timepoint(s) of evaluation of this end point
    All efficacy endpoints will be measured at the follow-up visit (day 71-75), ideally within 2 days of the last dose of IMP. The surgery will be performed within one week of the end of the treatment.
    All safety endpoints will be assessed at the end of treatment cycle 1, within 7 days of the end of the cycle, and at follow-up (day 71-75), ideally within 2 days of the last dose of the study treatment. TEAEs / TESAEs will be recorded during the study, starting on Day 1 of treatment.
    Tutti gli endpoint di efficacia saranno misurati alla visita di follow-up (giorno 71-75), idealmente entro 2 giorni dall’ultima dose di IMP. L’intervento chirurgico verrà effettuato entro una settimana dal termine del trattamento.
    Tutti gli endpoint di sicurezza saranno valutati alla fine del ciclo1 di trattamento, entro 7 giorni dalla fine del ciclo, e al follow-up, (giorno 71-75), idealmente entro 2 giorni dall’ultima dose del trattamento in studio. TEAEs/TESAEs verranno registrati durante lo studio, partendo dal Giorno 1 di trattamento.
    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 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) 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.8.2.4Number 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 concerned2
    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 Information not present in EudraCT
    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
    For the purpose of this trial, the end of study is defined as the date of the last procedure (date of bariatric surgery) of the last patient.
    Ai fini di questa sperimentazione, la fine dello studio è definita come la data dell'ultima procedura (data della chirurgia bariatrica) dell'ultimo paziente.
    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 months3
    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 months3
    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 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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 32
    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 completion of the follow-up visit and of surgery, patients will receive post-study care as prescribed by their health care provider. No post-study treatment will be provided by Dompé.
    Dopo il completamento della visita di follow-up e dell'intervento chirurgico, i pazienti riceveranno cure post-studio come prescritto dal proprio medico. Nessun trattamento post-studio sarà fornito da Dompé.
    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 Decision2020-12-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-04-21
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