Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-02 @ 3:06 AM
Study NCT ID:
NCT06817356
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719829', 'term': 'mazdutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-02-05', 'studyFirstSubmitQcDate': '2025-02-05', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Behaviors Associated with Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method', 'timeFrame': 'Baseline, Week 28'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Use Disorder']}, 'descriptionModule': {'briefSummary': 'The objective of this proof-of-concept study to evaluate mazdutide in participants with alcohol use disorder (AUD).\n\nFor any individual participant, the maximum duration of study participation is approximately 36 weeks, including screening and posttreatment follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current AUD diagnosis as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria.\n\nExclusion Criteria:\n\n* Have a history of significant active or unstable major depressive disorder, suicidal ideation, or other severe psychiatric disorder within the last 12 months.\n* Have initiated psychotherapy, changed the intensity of psychotherapy, or other nondrug therapies (for example, acupuncture or hypnosis) within 8 weeks prior to enrollment.\n* Have received any medication for AUD in the last 30 days including but not limited to, disulfiram, acamprosate, naltrexone, gabapentin, baclofen, or topiramate.\n* Other protocol-specific inclusion and exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06817356', 'briefTitle': 'A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 2, Double-Blind, Proof of Concept Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder', 'orgStudyIdInfo': {'id': '27290'}, 'secondaryIdInfos': [{'id': 'I8P-MC-OXAH', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mazdutide', 'description': 'Mazdutide administered subcutaneously (SC).', 'interventionNames': ['Drug: Mazdutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administered SC.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Mazdutide', 'type': 'DRUG', 'otherNames': ['LY3305677'], 'description': 'Administered SC', 'armGroupLabels': ['Mazdutide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '480-330-7485'}, {'name': 'Brandon Lawrence', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Headlands Research - Scottsdale', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '501-221-8681'}, {'name': 'George Konis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Woodland International Research Group', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72758', 'city': 'Rogers', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '479-927-3000'}, {'name': 'Robert Billingsley', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Woodland Resarch Northwest/ERG', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '714-988-2021'}, {'name': 'Justin Yanuck', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ark Clinical Research - Fountain Valley', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '91945', 'city': 'Lemon Grove', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '619-303-6130'}, {'name': 'Charmaine Semeniuk', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Synergy San Diego', 'geoPoint': {'lat': 32.74255, 'lon': -117.03142}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '858-278-3647'}, {'name': 'Eric Chavez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Headlands Research-Artemis San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '954-990-7649'}, {'name': 'Edwin Gomez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Research Centers of America ( Hollywood )', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '407-676-5252'}, {'name': 'Sejal Patel', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'K2 Medical Research - Maitland', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '407-500-5252'}, {'name': 'Brady Bradshaw', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'K2 Medical Research', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '904-281-5757'}, {'name': 'Mark Joyce', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinical Neuroscience Solutions Inc', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '407-425-5100'}, {'name': 'Robert Molpus', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinical Neuroscience Solutions, Inc.', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '813-500-5252'}, {'name': 'Kelley Yokum', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'K2 Medical Research - Tampa', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '404-537-1281'}, {'name': 'Kimball Johnson', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CenExel iResearch, LLC (CenExel iRA)', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '70471', 'city': 'Mandeville', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '504-336-2667'}, {'name': 'Rachel Murphy', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'DelRicht Research', 'geoPoint': {'lat': 30.35825, 'lon': -90.06563}}, {'zip': '02472', 'city': 'Watertown', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '617-744-8542'}, {'name': 'Daniel Rutrick', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Adams Clinical', 'geoPoint': {'lat': 42.37093, 'lon': -71.18283}}, {'zip': '01608', 'city': 'Worcester', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '413-363-5206'}, {'name': 'James Carroll', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vitalix Clinical', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '89119', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '702-577-2000'}, {'name': 'Jelena Kunovac', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Redbird Research LLC', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '87019', 'city': 'Albuquerque', 'state': 'New Mexico', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '505-848-3773'}, {'name': 'Shayne Ladak', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IMA Clinical Research Albuquerque', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10314', 'city': 'Staten Island', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '718-751-6750'}, {'name': 'Adam Smith', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Richmond Behavioral Associates', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '315-904-5004'}, {'name': 'Karl Hafner', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ichor Research', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '646-568-5162'}, {'name': 'Shama Farooq', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Davis Clinical', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '503-314-3900'}, {'name': 'Beal Essink', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Summit Headlands', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '02914', 'city': 'East Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '401-435-8950'}, {'name': 'john stoukides', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rhode Island Mood & Memory Research Institute', 'geoPoint': {'lat': 41.81371, 'lon': -71.37005}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Book', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '901-843-1045'}, {'name': 'Lora McGill', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinical Neuroscience Solutions Inc', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75251', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '214-369-2600'}, {'name': 'Michael Downing', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'FutureSearch Trials of Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75080', 'city': 'Richardson', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '214-396-4844'}, {'name': 'Scott Bartley', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dallas Clinical Research Center/Pillar Research', 'geoPoint': {'lat': 32.94818, 'lon': -96.72972}}], 'centralContacts': [{'name': 'Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or', 'role': 'CONTACT', 'email': 'LillyTrials@Lilly.com', 'phone': '1-317-615-4559'}, {'name': 'Physicians interested in becoming principal investigators please contact', 'role': 'CONTACT', 'email': 'clinical_inquiry_hub@lilly.com'}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'http://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}