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    EudraCT Number:2016-003343-11
    Sponsor's Protocol Code Number:GLP1ALCOHOL
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-01-27
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2016-003343-11
    A.3Full title of the trial
    Does Glucagon-like Peptide 1 (GLP-1) receptor stimulation reduce alcohol intake in patients with alcohol dependence?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Does stimulation of the receptor for Glucagon-like Peptide 1 (GLP-1) reduce alcohol intake in patients with alcohol dependence?
    A.4.1Sponsor's protocol code numberGLP1ALCOHOL
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03232112
    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 SponsorPsychiatric Centre Copenhagen
    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 supportRegion Hovedstadens Forskningsfond
    B.4.1Name of organisation providing supportRegion Hovedstadens Psykiatri
    B.4.1Name of organisation providing supportFonden Novaví
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPsychiatric Centre Copenhagen
    B.5.2Functional name of contact pointMette Kruse Klausen
    B.5.3 Address:
    B.5.3.1Street AddressEdel Sauntes Allé 10
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    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. name Bydureon
    D. of the Marketing Authorisation holderAstraZeneca 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.3.4Pharmaceutical form Powder and solvent for 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 INNEXENATIDE
    D.3.9.1CAS number 141758-74-9
    D.3.9.4EV Substance CodeSUB21818
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    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
    Alcohol dependence
    E.1.1.1Medical condition in easily understood language
    Alcohol dependence
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001125
    E.1.2Term Addiction
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to investigate the effects of the GLP-1 receptor agonist Bydureon® on total number of heavy drinking days from baseline to follow up after 26 weeks of treatment in patients with alcohol dependence in a 26-weeks double-blinded, randomized placebo-controlled clinical trial. )). Furthermore, patients will be approached 26 weeks after end participation, in order to evaluate whether or not there is a long-term effect of the intervention on the TLFB questionnaire.
    E.2.2Secondary objectives of the trial
    We also wish to explore the neuromolecular and neuroanatomical underpinnings of the potential beneficial effects of Bydureon® treatment in the brain by use of the brain imaging techniques brain single photon emission tomography (SPECT) and functional magnetic resonance imaging (fMRI).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Informed oral and written consent
    • Diagnosed with alcohol dependence according to the criteria of International Classification of Dis-eases (ICD) 10, World Health Organization and DSM-5
    • Alcohol use disorder identification test (AUDIT) score >15 (29)
    • Age 18 - 70 years
    • Heavy alcohol drinking defined as having alcohol consumption over 60 g of alcohol per day (men) or 48 g of alcohol per day (women) for at least 5 days in the past 30 days prior to inclusion measured by the TLFB method.
    E.4Principal exclusion criteria
    • Severe psychiatric disease, defined as a diagnosis of schizophrenia, paranoid psychosis, bipolar dis-order or mental retardation
    • A history of delirium tremens or alcohol withdrawal seizures
    • No serious withdrawal symptoms at inclusion (a score higher than 9 on the Clinical Institute With-drawal Assessment of Alcohol Scale, Revised (CIWA-Ar)) at baseline examinations.
    • Present or former neurological disease including traumatic brain injury
    • Type 1 diabetes, type 2 diabetes or HbA1c ≥48 mmol/l at inclusion
    • Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using contraceptive measures considered as highly effective (30)
    • Impaired hepatic function (liver transaminases >3 times upper normal limit)
    • Impaired renal function (se-creatinine >150 μM and/or macro albuminuria)
    • Impaired pancreatic function (any history of acute or chronic pancreatitis and/or amylase > 2 times upper limit)
    • S-triglycerides >10 mmol/l.
    • Former medullary thyroid carcinoma (MTC) and/or family history with MTC and/or Multiple Endo-crine Neoplasia syndrome type 2 (MEN 2)
    • Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pec-toris and/or myocardial infarction within the last 12 months
    • Uncontrolled hypertension (systolic blood pressure >180 mmHg, diastolic blood pressure >110 mmHg)
    • Concomitant pharmacotherapy against alcohol dependence including disulfiram, naltrexone, acamprosate and nalmefene or treatment with any of these compounds within 1 months prior to inclusion
    • Concomitant pharmacotherapy with dopamine active drugs, such as some types of Attention Defi-cit Hyperactivity Disorder (ADHD) medication (methylphenidat).
    • Receiving any investigational drug within the last 3 months
    • Use of weight-lowering pharmacotherapy within the preceding 3 month
    • Any other active substance use defined as a DUDIT-score > 6 (for men) >2 (for women) and fulfilling the criterias for dependence of the substance according to the criteria of International Classifica-tion of Diseases (ICD) 10 (except nicotine)
    • BMI <18,5 kg/m2
    • Contraindications for undergoing a fMRI scan (magnetic implants, pacemaker, claustrophobia etc.)
    • Contraindications for undergoing a SPECT-scan: radiation exposure, excluding background radia-tion but including diagnostic x-rays and other medical exposures, exceeding 10 mSv in the last 12 months
    • Allergy towards iodine.
    • Unable to speak and/or understand Danish
    • Any condition that the investigator feels would interfere with trial participation
    E.5 End points
    E.5.1Primary end point(s)
    Percent reduction in total number of heavy drinking days and defined as days with an excess intake of 60/48 grams of alcohol per day (men and women, respectively) from baseline to follow-up after 26 weeks of treatment measured by the Time Line Follow Back (TFLB) method.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Q4, 2020
    E.5.2Secondary end point(s)
    Secondary endpoints include changes in total alcohol consumption (g/30 days measured by TLFB), changes in number of days without alcohol consumption and Penn Alcohol Craving Scale (PACS) score, change in Alcohol Use Disorders Identification Test (AUDIT) score, Drug Use Disorders Identification Test (DUDIT) score, change in the liver parameters gamma-glutamyltransferase (GGT), alanine aminotransferase (ALAT), and phosphatidyl-ethanol (PEth). Safety will also be evaluated through measure-ments of pancreatic function (the pancreatic parameters amylase and lipase together with clinical evaluation). Other parameters will be mean cell volume (MCV), changes in body weight, blood pressure, pulse, overall glycaemic con-trol parameters (HbA1c), kidney function (p-creatinine, eGFR and urine albu-min/creatinine ratio) and measures of health (Short Form Health Survey (SF-36), life quality (The WHO-Five Well-being Index (WHO-5)) and Symptom Checklist (SCL-92)). )). Furthermore, patients will be approached 26 weeks after end participation, in order to evaluate whether or not there is a long-term effect of the intervention on the TLFB questionnaire.

    In addition to these clinical outcome parameters we will explore the possible neuromolecular effects by measuring striatal dopamine transporter (DAT) availability before and after administration of Bydureon® by use of the Single-photon emission computed tomography (SPECT). The possible neuroanatomical underpinnings of Bydureon® will be investigated by use of functional Magnetic Resonance Imaging (fMRI). These examinations will be performed in two subgroups of patients treated with either Bydureon® or placebo. To have comparable standard data of the alcohol related fMRI paradigm, we will include 25 healthy participants with no record of alcohol dependence. They will be matched with gender and age of the patients and undergo one fMRI scan.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Changes in total alcohol consumption (g/day), changes in number of days without alcohol consumption, change AUDIT score, DUDIT score, change in GGT, ALAT and PEth. Safety, (MCV), changes in body weight, blood pressure, pulse, overall glycaemic control parameters, kidney function, SF-36 and SCL-92. Striatal dopamine transporter (DAT) availability and neuroanatomical underpinnings of Bydureon®: June 2020
    Long-term (26 weeks) effect of the intervention: December 2020.
    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. 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 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
    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 months0
    E.8.9.1In the Member State concerned 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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 59
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state169
    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)
    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 Decision2017-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-10-06
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