A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1)

2025-522313-38-00 Protocol J2S-MC-GZME Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 6 Mar 2026 · Status Ongoing, recruiting · 2 EU/EEA countries · 12 sites · Protocol J2S-MC-GZME

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruiting
Participants planned 1,090
Countries 2
Sites 12

Alcohol Use Disorder

Period 1 Primary Objective To demonstrate that at least 1 dose level of brenipatide is superior to placebo for at least 1 of the dual primary endpoints Period 2 Primary Objective For brenipatide responders from Period 1: To evaluate the ability of brenipatide (pooled across doses) to maintain a general reducti…

Key facts

Sponsor
Eli Lilly & Co.
Participant type
Patients
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
Trial duration
6 Mar 2026 → ongoing
Decision date (initial)
2026-02-05
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Diagnosis, Dose response, Pharmacokinetic, Therapy, Efficacy

Period 1
Primary Objective
To demonstrate that at least 1 dose level of brenipatide is superior to placebo for at least 1 of the dual primary endpoints



Period 2
Primary Objective
For brenipatide responders from Period 1: To evaluate the ability of brenipatide (pooled across doses) to maintain a general reduction in alcohol consumption endpoint

Conditions and MedDRA coding

Alcohol Use Disorder

Regulatory references

Scientific advice from competent authorities
European Medicines Agency
Plan to share IPD
Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Motivated to stop or cut down on drinking.
  2. Willing to take part in the whole study and go to all the needed visits
  3. 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 2

  1. 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.
  2. 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 and secondary outcome measures (English text)

Primary endpoints 1

  1. Behaviors Associated with Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Brenipatide

PRD12713220 · Product

Active substance
LY3537031
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Route of administration
SUBCUTANEOUS USE
Max daily dose
0 Other
Max total dose
0 Other
Max treatment duration
1 Day(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Brenipatide

PRD12713219 · Product

Active substance
LY3537031
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Route of administration
SUBCUTANEOUS USE
Max daily dose
0 Other
Max total dose
0 Other
Max treatment duration
1 Day(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Brenipatide

PRD12713221 · Product

Active substance
LY3537031
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Route of administration
SUBCUTANEOUS USE
Max daily dose
0 Other
Max total dose
0 Other
Max treatment duration
1 Day(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Placebo 1

Placebo to match LY

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eli Lilly & Co.

137 Total trials 45 Recruiting 84 Ended
Commercial
Sponsor organisation
Eli Lilly & Co.
Address
1 Lilly Corporate Center
City
Indianapolis
Postcode
46285-0001
Country
United States

Scientific contact point

Organisation
Eli Lilly & Co.
Contact name
Lilly Clinical Trials information desk

Public contact point

Organisation
Eli Lilly & Co.
Contact name
Lilly Clinical Trials information desk

Third parties 10

OrganisationCity, countryDuties
Trialbee AB
ORG-100051369
 Malmo, Sweden Other
Indiana University
ORG-100047213
 Bloomington, United States Other
Labcorp Central Laboratory Services LP
ORG-100032236
 Indianapolis, United States Other
Cleveland Clinic Foundation
ORG-100028017
 Cleveland, United States Other
Bioagilytix Labs LLC
ORG-100013030
 Durham, United States Other
Greenphire LLC
ORG-100041621
 King Of Prussia, United States Other
Icon Clinical Research LLC
ORG-100039864
 Rochester, United States Other
Iqvia Biotech LLC
ORG-100008704
 Durham, United States On site monitoring
RWS Life Sciences Inc.
ORG-100042348
 East Hartford, United States Other, Data management
The Hibbert Co.
ORG-100047639
 Trenton, United States Other

Locations

2 EU/EEA countries · 12 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ongoing, recruiting 47 5
Germany Ongoing, recruiting 50 7
Rest of world
China, Japan, United States, Taiwan, United Kingdom, Argentina, Korea, Democratic People's Republic of
 — 993 —

Investigational sites

Belgium

5 sites · Ongoing, recruiting
Medisch Centrum Saffrou
Kormont, Johanna van der Gheynststraat 1 bus 0101, 9636, Oudenaarde
Gezondheidshuis De Gloed
Kormont, Rujksweg 128A, 9870, Machelen
Meclinas
Meclinas, Stationsstraat 102-108, 2800, Mechelen
Kormont
Kormont, Kwaremontplein 45, 9690, Kluisbergen
Anima
Anima, Wetenschapspark 11-13, 3590, Diepenbeek

Germany

7 sites · Ongoing, recruiting
FutureMeds GmbH
N/A, Wilmersdorfer Strasse 79, Charlottenburg, Berlin
Klinische Forschung Schwerin GmbH
N/A, Friedrichstrasse 1, Altstadt, Schwerin
Velocity Clinical Research Germany GmbH
N/A, Ansbacher Strasse 17-19, Schoeneberg, Berlin
Klinische Forschung Dresden GmbH
N/A, Prager Strasse 10, Seevorstadt-Ost/Grosser Garten, Dresden
Klinische Forschung Hamburg GmbH
N/A, Hoheluftchaussee 18, Hoheluft-Ost, Hamburg
FutureMeds GmbH
N/A, Platz Der Deutschen Einheit 4, 63065, Offenbach Am Main
Zentralinstitut Fuer Seelische Gesundheit
N/A, Luisenring J 5, 68159, Mannheim

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Belgium 2026-03-13 2026-03-17
Germany 2026-03-06 2026-03-09

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 52 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2025-522313-38-00_GZME_Redacted b
Protocol (for publication) D4_Patient Documents Copyright statement 1
Protocol (for publication) D4_Patient facing documents_PGI Severity Alcohol Use Heavy Drinking_BEDU 1.0
Protocol (for publication) D4_Patient facing documents_PGI Severity Alcohol Use Social_BEDU 1.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements 1.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements_Recruitment and Informed Consent Procedure_BE 1.0
Recruitment arrangements (for publication) K2 Recruitment Material_Recruitment texts_FutureMeds_Offenbach 1.2
Recruitment arrangements (for publication) K2_Breni_HowToInject_video script 2.0
Recruitment arrangements (for publication) K2_Breni_HowToInject_video script_BEDU 1.0
Recruitment arrangements (for publication) K2_Breni_HowToInject_video script_BEFR 1.0
Recruitment arrangements (for publication) K2_Recruitment Material_ Advertisement_Pratia Germany 1
Recruitment arrangements (for publication) K2_Recruitment material_Brochure_BEDU_redacted 1.2
Recruitment arrangements (for publication) K2_Recruitment material_Brochure_BEFR_Redacted 1.2
Recruitment arrangements (for publication) K2_Recruitment Material_Brochure_Master_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment Material_Facebook-Ads ZI Mannheim 1
Recruitment arrangements (for publication) K2_Recruitment material_Flyer_BEDU 1.1
Recruitment arrangements (for publication) K2_Recruitment material_Flyer_BEFR 1.1
Recruitment arrangements (for publication) K2_Recruitment Material_Flyer_Master 1
Recruitment arrangements (for publication) K2_Recruitment Material_Landing_Page_ZI_Mannheim 1
Recruitment arrangements (for publication) K2_Recruitment material_Letter Doctor Referral_BEDU_redacted 1.2
Recruitment arrangements (for publication) K2_Recruitment material_Letter Doctor Referral_BEFR_redacted 1.2
Recruitment arrangements (for publication) K2_Recruitment Material_Letter-Doctor-to-Patient_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment material_Neuro alcohol use disorder_BEDU 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Neuro alcohol use disorder_BEFR 1.0
Recruitment arrangements (for publication) K2_Recruitment Material_Neuro_Alcohol-Use-Disorder 1
Recruitment arrangements (for publication) K2_Recruitment material_Poster_BEDU 1.1
Recruitment arrangements (for publication) K2_Recruitment material_Poster_BEFR 1.1
Recruitment arrangements (for publication) K2_Recruitment Material_Poster_Master 1
Recruitment arrangements (for publication) K2_Recruitment Material_Prescreening_tool_questions_Pratia Germany 1
Recruitment arrangements (for publication) K2_Recruitment Material_Recruitment texts_FutureMeds_Berlin 1.2
Recruitment arrangements (for publication) K2_Recruitment Material_What-Is-A-Placebo_Master 1
Subject information and informed consent form (for publication) L1_SIS and ICF Main_GZME_Redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_BEDU_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_BEFR_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_ENG_Redacted 1.1
Subject information and informed consent form (for publication) L1_Study Participants Pregnant Partner 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_CompleteConsent Participant-Facing Screenshots_Redacted_BEDU 1.4
Subject information and informed consent form (for publication) L2_Other subject information material_CompleteConsent Participant-Facing Screenshots_Redacted_BEFR 1.4
Subject information and informed consent form (for publication) L2_Other subject information material_CompleteConsent Participant-Facing Screenshots_Redacted_EN 1.4
Subject information and informed consent form (for publication) L2_Other Subject information material_ICF_Sponsor_Statement_ENG_Redacted 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_IFU_Brenipatide_BEDU 2.0
Subject information and informed consent form (for publication) L2_Other subject information material_IFU_Brenipatide_BEFR 2.0
Subject information and informed consent form (for publication) L2_Other subject information material_IQVIA eConsent Privacy Policy_BEDU 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_IQVIA eConsent Privacy Policy_BEFR 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_IQVIA eConsent Privacy Policy_ENG 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_Patient-facing landing page_Redacted_BEDU 1.1
Subject information and informed consent form (for publication) L2_Other subject information material_Patient-facing landing page_Redacted_BEFR 1.1
Subject information and informed consent form (for publication) L2_Other subject information material_Patient-facing landing page_Redacted_ENG 1.1
Synopsis of the protocol (for publication) D1_Protocol Synopsis_BEDU_2025-522313-38-00_Redacted b
Synopsis of the protocol (for publication) D1_Protocol Synopsis_BEFR_2025-522313-38-00_Redacted b
Synopsis of the protocol (for publication) D1_Protocol Synopsis_BEGE_2025-522313-38-00_Redacted b
Synopsis of the protocol (for publication) D1_Protocol Synopsis_EN_2025-522313-38-00_Redacted b

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-10-13 Germany Acceptable
2026-02-02
 2026-02-05

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