Clinical trial • Phase III • Psychiatry
LY3537031 for Alcohol use disorder
Phase III trial of LY3537031 for Alcohol use disorder.
Overview
- Trial Therapeutic Area
- Psychiatry
- Trial Disease
- Alcohol use disorder
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 13-10-2025
- First CTIS Authorization Date
- 05-02-2026
Trial design
Randomised, placebo to match ly (placebo comparator); dose/schedule not specified in the ctis record-controlled Phase III trial in Belgium, Germany.
- Randomised
- Yes
- Comparator
- Placebo to match LY (placebo comparator); dose/schedule not specified in the CTIS record
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 993
Eligibility
Recruits 993 No vulnerable populations selected (isVulnerablePopulationSelected: false). Consent materials and eConsent available (participant-facing landing page, ICFs, IQVIA eConsent Privacy Policy) in English and Belgian language versions (BEFR, BEDU) as per submitted documents..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false). Consent materials and eConsent available (participant-facing landing page, ICFs, IQVIA eConsent Privacy Policy) in English and Belgian language versions (BEFR, BEDU) as per submitted documents.
Inclusion criteria
- {"criterion_text":"- Motivated to stop or cut down on drinking."}
- {"criterion_text":"- Willing to take part in the whole study and go to all the needed visits"}
- {"criterion_text":"- Willing to do what the study asks, like giving yourself the medicine, keeping and using the medicine as told, writing in study diaries, and answering questions."}
Exclusion criteria
- {"criterion_text":"- Used or currently use illegal drugs or medicines that were not prescribed to you in the past 180 days. This does not include alcohol, nicotine, or caffeine."}
- {"criterion_text":"- Had serious liver problems in the past, like bad liver scarring (fibrosis or cirrhosis) or liver disease caused by alcohol, based on past liver tests or scans (like ultrasound, CT, MRI, or special blood tests)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Behaviors Associated with Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)","definition_or_measurement_approach":"Assessed by the Timeline Followback Method (TLFB) to measure behaviors associated with AUD."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 993
- Recruitment Window Months
- 26
- Consent Approach
- Informed consent via eConsent and standard ICFs. Participant-facing landing pages and CompleteConsent eConsent screenshots are provided. ICF and related materials available in English and Belgian language versions (BEFR, BEDU). Consent is provided by the adult participant (no paediatric/assent process indicated).
Methods
- Flyers/posters and brochures (country-specific versions: BEFR, BEDU) for general public recruitment (Belgium, Germany).
- Patient-facing landing page / online landing pages (ENG, BEFR, BEDU) to inform and recruit participants.
- Facebook advertisements (Germany - ZI Mannheim / FutureMeds materials) as listed in recruitment documents.
- Doctor referral letters and physician outreach (Letter Doctor Referral documents).
- Pre-screening tool / prescreening questionnaire (Pratia Germany pre-screening tool).
- Video materials (HowToInject video script) to instruct participants.
- Third-party patient referral and recruitment partners (e.g., Trialbee) supporting patient referral, screening and retention.
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 97
Belgium
- Earliest CTIS Part Ii Submission Date
- 02-02-2026
- Latest Decision Or Authorization Date
- 05-02-2026
- Processing Time Days
- 3
- Number Of Sites
- 5
- Number Of Participants
- 47
Sites
- Site Name
- Kormont
- Department Name
- Kormont
- Contact Person Name
- Klaas Vercruysse
- Contact Person Email
- klaas.vercruysse@telenet.be
- Site Name
- Medisch Centrum Saffrou
- Department Name
- Kormont
- Contact Person Name
- Klaas Vercruysse
- Contact Person Email
- klaas.vercruysse@telenet.be
- Site Name
- Gezondheidshuis De Gloed
- Department Name
- Kormont
- Contact Person Name
- Klaas Vercruysse
- Contact Person Email
- klaas.vercruysse@telenet.be
- Site Name
- Meclinas
- Department Name
- Meclinas
- Contact Person Name
- Claudia Cornelis
- Contact Person Email
- claudia.cornelis@meclinas.com
- Site Name
- Anima
- Department Name
- Anima
- Contact Person Name
- Erik Buntinx
- Contact Person Email
- erik.buntinx@anima-alken.be
Germany
- Earliest CTIS Part Ii Submission Date
- 13-01-2026
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 27
- Number Of Sites
- 7
- Number Of Participants
- 50
Sites
- Site Name
- FutureMeds GmbH
- Contact Person Name
- Peter Hahn
- Contact Person Email
- peter.hahn@futuremeds.com
- Site Name
- Klinische Forschung Schwerin GmbH
- Contact Person Name
- Christine Paschen
- Contact Person Email
- christine.paschen@pratia.com
- Site Name
- Klinische Forschung Hamburg GmbH
- Contact Person Name
- Christian Deckert
- Contact Person Email
- christian.deckert@pratia.com
- Site Name
- FutureMeds GmbH (Offenbach Am Main)
- Contact Person Name
- Florieke Berfelo
- Contact Person Email
- info@futuremeds.com
- Site Name
- Klinische Forschung Dresden GmbH
- Contact Person Name
- Peter Heymer
- Contact Person Email
- heymer@kfgn.de
- Site Name
- Zentralinstitut Fuer Seelische Gesundheit
- Contact Person Name
- Patrick Bach
- Contact Person Email
- patrick.bach@zi-mannheim.de
- Site Name
- Velocity Clinical Research Germany GmbH
- Contact Person Name
- Isabelle Schenkenberger
- Contact Person Email
- schenkenberger@klinische-forschung-berlin.de
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research LLC
- Responsibilities
- Imaging
- Name
- Iqvia Biotech LLC
Third parties
- {"country":"Sweden","full_name":"Trialbee AB","duties_or_roles":"Patient Referral, Recruitment, Screening, and/or Retention","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Indiana University","duties_or_roles":"Statistics - SDTM and ADAM Data set creation and validation","organisation_type":"Educational Institution"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Laboratory & Diagnostics","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cleveland Clinic Foundation","duties_or_roles":"Adjudication","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Immunogenicity","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Screening, Recruitment and Retention","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Icon Clinical Research LLC","duties_or_roles":"Imaging","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Copyright licensing, Linguistically Validated Translations","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"The Hibbert Co.","duties_or_roles":"Patient Screening, Recruitment, and/or Retention","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Brenipatide
- Active Substance
- LY3537031
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Investigational Product Name
- Placebo to match LY
- Modality
- Other
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