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LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis

StatusRecruiting
PhasePhase 3
Started2024-11-12
View on ClinicalTrials.gov ↗

Amendment history

2026-09-01
minor
Study Status, Contacts/Locations v44
Study sitesdetails revised at 8 of 445 sites
2026-08-20
minor
Study Status, Contacts/Locations v43
Start date2024-11-07→2024-11-12
Study sites444→445
2026-08-07
minor
Study Status, Contacts/Locations v42
Study sites444 entries, revised
Great Lakes Gastroenterology VCU Research,Medical LLC Center West Hospital Italiano de Buenos Aires Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Union Hospital Tongji Medical College Huazhong University of Science and Technology Second Affiliated Hospital of medical college of Xi'an JiaoTong University St Luke's Cancer Centre
2026-07-07
minor
Study Status, Contacts/Locations v41
Study sites444 entries, revised
Synergy Healthcare of Tampa Medical University of Graz ULB Hopital Erasme EdegemUniversitair - UNIV UZZiekenhuis Antwerpen Hospital das Clinicas da Universidade Federal de Minas Gerais (HCUFMGHC-UFMG) Hospital das ClinicasClínicas da Faculdade de Medicina da USP Hospital de Base - Fac Med de Sao Jose do Rio Preto Acibadem City Clinic Tokuda University Multiprofile Hospital for Active Treatment Tokuda EAD Universitätsklinikum Mannheim GmbHHeidelberg
2026-06-23
minor
Study Status, Contacts/Locations v40
Trial sites reduced: 447 → 444 locations
2026-06-09
minor
Study Status, Contacts/Locations v39
Trial sites expanded: 444 → 447 locations
2026-05-27
minor
Study Status, Contacts/Locations v38
Study sites443→444
2026-05-12
minor
Study Status, Contacts/Locations v37
Study sites443 entries, revised
TopCenara MedicalClinical Research, Innovative IncClinical Research Premier Medical Group HospitalKlinik Hietzing Royal Devon and Exeter Hospital, Wonford
2026-04-28
minor
Study Status, Contacts/Locations v36
Trial sites expanded: 438 → 443 locations
2026-04-15
minor
Study Status, Contacts/Locations v35
Trial sites expanded: 435 → 438 locations
2026-04-01
minor
Study Status, Contacts/Locations v34
Trial sites expanded: 430 → 435 locations
2026-03-17
minor
Study Status, Arms and Interventions, Contacts/Locations v33
InterventionsPlacebo matching survodutide (Drug), Survodutide (Drug)→Placebo matching survodutide (Combination Product), Survodutide (Combination Product)
Study sites430 entries, revised
Kansas City GastroenterologyResearch & Hepatology Physicians GroupInstitute South Texas Research Institute - Brownsville-68426 Fondazione Policlinico Universitario A.Agostino Gemelli IRCCS
2026-03-05
minor
Study Status, Contacts/Locations, References v32
Start date2024-11-12→2024-11-07
Study sites432→430
2026-02-17
minor
Study Status, Contacts/Locations v31
Study sites424→432
2026-02-05
minor
Study Status, Contacts/Locations, IPDSharing v30
Study sites423→424
2026-01-07
minor
Study Status, Contacts/Locations v29
Study sites419→423
2025-12-19
minor
Study Status, Contacts/Locations v28
Study sites419 entries, revised
Velocity Clinical Research, Waco Hospital das Clinicas da FMUSP ImperialFaculdade Collegede HealthcareMedicina NHSda TrustUSP
2025-12-10
minor
Study Status, Contacts/Locations v27
Study sites421→419
2025-11-26
minor
Study Status, Contacts/Locations v26
Study sites420→421
2025-11-11
minor
Study Status, Contacts/Locations v25
Study sites420 entries, revised
The Institute for Liver Health, LLCII DBA Arizona Clinical Trials InstitutoCentro Oncologicode Ltda.Investigaciones Clinicas Viña del Mar Hopitaux UniversitairesHôpital Henri Mondor Practice (HopitalDr Henri-Mondor) SociedadRosa deIsela MetabolismoLuna y Corazón S.C.Ceballos Hospital Universitario Reina Sofía-Córdoba-40500 Panthera Biopartners - ManchesterRochdale
2025-10-30
minor
Study Status, Contacts/Locations v24
Study sites419→420
2025-10-14
minor
Study Status, Contacts/Locations v23
Start date2024-12-02→2024-11-12
Study sites416→419
2025-09-17
minor
Study Status, Eligibility, Contacts/Locations v22
Study sites418→416
Eligibility criteria+2 characters
[...] lirubin is <20% of TBL. Alkaline phosphatase >1.5x ULN PLT <75100,000/µL (<75100 GI/L) History or evidence of other chronic liver diseases, [...]
2025-09-03
minor
Study Status, Contacts/Locations v21
Study sites437→418
2025-08-05
minor
Study Status, Eligibility, Contacts/Locations v20
Study sites436→437
Eligibility criteriarevised
[...] lirubin is <20% of TBL. Alkaline phosphatase >1.5x ULN PLT <9075,000/µL (<9075 GI/L) History or evidence of other chronic liver diseases, [...]
2025-07-25
minor
Study Status, Contacts/Locations v19
Study sites438→436
2025-07-08
minor
Study Status, Contacts/Locations v18
Study sitesdetails revised at 8 of 438 sites
2025-06-24
minor
Study Status, Contacts/Locations v17
Study sites434→438
2025-06-16
minor
Study Status, Contacts/Locations v16
Study sites435→434
2025-06-02
minor
Study Status, Contacts/Locations v15
Study sites429→435
2025-05-15
minor
Study Status, Contacts/Locations v14
Study sitesdetails revised at 16 of 429 sites
2025-04-30
minor
Study Status, Outcome Measures, Eligibility, Contacts/Locations v13
Study sites361→429
Eligibility criteria-117 characters
[...] olic dysfunction-associated steatohepatitis (MASH) cirrhosis diagnosed according to modified Liver Forum criteria (Noureddin et al, Gastroenterology 2020;159:422-427). Magnetic resonance imaging proton density fat fraction (MR [...] obtained during the screening period or a historic MRI-PDFF or FibroScan® with CAP ≤12 weeks prior to randomisation (except for patients with ' [...] pensation event of any of the following but not limited to: History of portalPortal hypertension-related upper gastrointestinal (GI) bleeding A [...] ct bilirubin is <20% of TBL. Alkaline phosphatase >1.5x ULN Platelet countPLT <10090,000 [...] [...]
Secondary endpoints14 to 13 entries
Key secondary endpoint: Absolute change from baseline in enhanced liver fibrosis (ELF) score Key secondary endpoint: Percentage change from baseline in body weight Key secondary endpoint: Absolute change from baseline in glycosylated haemoglobin A1c (HbA1c) (%) in participants with type 2 diabetes mellitus (T2DM) at baseline Key (%) Absolutesecondary changeendpoint: from baseline in HbA1c in participants with T2DM at baseline (mmol/mol) Absolute change from baseline in liver stiffness (kPa) in FibroScan® vibration-controlled transient elastography (VCTE) (kPa) Absolute change from baseline in [...] [...]
2025-04-11
minor
Study Status, Contacts/Locations v12
Start date2024-11-12→2024-12-02
Study sites381→361
2025-03-19
minor
Study Status, Contacts/Locations v11
Study sites386→381
2025-03-11
minor
Study Status, Contacts/Locations v10
Study sites387→386
2025-02-27
minor
Study Status, Contacts/Locations v9
Study sites387 entries, revised
FQLDelta Research Partners, LLC
2025-02-19
minor
Study Status, Contacts/Locations v8
Study sites363→387
2025-01-30
minor
Study Status, Contacts/Locations v7
Study sites10→363
2025-01-13
minor
Study Status, Contacts/Locations v6
Study sites9→10
2024-12-20
minor
Study Status, Contacts/Locations v5
Study sites8→9
2024-12-09
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-11-15→confirmed 2024-11-12
Study sites0→8
2024-11-13
notable
Recruiting→Not Yet Recruiting Study Status, Contacts/Locations v3
Trial statusRecruiting→Not Yet Recruiting
Start date2024-10-02→2024-11-15
Study sites4→0
2024-10-31
minor
Study Identification, Study Status, Contacts/Locations v2
Study sites1→4
2024-10-15
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-10-12→confirmed 2024-10-02
Study sites0→1
2024-10-08
minor
Original filing
This study is open to adults who are at least 18 years old and have: * A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or * A confirmed liver disease called metabolic-associated steatohepatitis (MASH) * BMI of 27 kg/m2 or more or * 25 kg/m2 or more if the participant is Asian. People with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function. Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.
Trial Details
NCT Number NCT06632457
Lead Sponsor Boehringer Ingelheim
Conditions Metabolic Dysfunction Associated Steatohepatitis
Enrollment 1,590 participants
Start Date 2024-11-12
Primary Completion 2029-06-05 (estimated)
Study Completion 2029-06-05 (estimated)
Updated on ClinicalTrials.gov 2026-10-01