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LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis

StatusRecruiting
PhasePhase 3
Started2024-10-14
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 51 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-08-20
minor
Study Status, Contacts/Locations v50
Start date2024-09-17→2024-10-14
Study sites527→528
2026-08-07
minor
Study Status, Contacts/Locations v49
Study sites525→527
2026-07-07
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Study Status, Contacts/Locations v48
Study sites525 entries, revised
Synergy Healthcare Medical College of VirginiaTampa VCU HospitalsMedical Center West Hospital Medical University of Graz ULB Hopital Erasme EdegemUniversitair - UNIV UZZiekenhuis Antwerpen Roeselare - HOSP AZ Delta Hospital das Clinicas da Universidade Federal de Minas Gerais (HCUFMGHC-UFMG) Centro de Pesquisa Clinica do Brasil Ltda Hospital das ClinicasClínicas da Faculdade de Medicina da USP Centro de Pesquisa Clinica do Brasil Hospital de Base - Fac Med de Sao Jose do Rio Preto Acibadem City Clinic Tokuda University Multiprofile Hospital for Active Treatment Tokuda EAD Universitätsklinikum [...]
2026-06-23
minor
Study Status, Contacts/Locations v47
Study sites526→525
2026-06-09
minor
Study Status, Contacts/Locations v46
Study sites526 entries, revised
RuijinHuashan Hospital, Shanghai Jiao TongFudan University School of Medicine
Show 4 earlier versions
2026-05-27
minor
Study Status, Contacts/Locations v45
Study sites525→526
2026-05-12
minor
Study Status, Contacts/Locations v44
Study sites524→525
2026-04-28
minor
Study Status, Contacts/Locations v43
Study sites525→524
2026-04-15
minor
Study Status, Contacts/Locations v42
Study sites526→525
2026-04-01
minor
Study Status, Contacts/Locations v41
Trial sites expanded: 522 → 526 locations
2026-03-17
minor
Study Status, Arms and Interventions, Contacts/Locations v40
Study sites518→522
InterventionsPlacebo (Drug), Survodutide (Drug)→Placebo (Combination Product), Survodutide (Combination Product)
2026-03-05
minor
Study Status, Contacts/Locations, References v39
Start date2024-10-14→2024-09-17
Study sites516→518
2026-02-17
minor
Study Status, Contacts/Locations v38
Study sites511→516
2026-02-05
minor
Study Status, Contacts/Locations, IPDSharing v37
Study sites508→511
2026-01-22
minor
Study Status, Contacts/Locations v36
Study sites507→508
2026-01-08
minor
Study Status, Contacts/Locations v35
Study sites506→507
2025-12-19
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Study Status, Contacts/Locations v34
Study sites494→506
2025-12-10
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Study Status, Contacts/Locations v33
Study sites482→494
2025-11-11
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Study Status, Contacts/Locations v32
Study sites471→482
2025-10-30
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Study Status, Contacts/Locations v31
Study sites470→471
2025-10-14
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Study Status, Contacts/Locations v30
Study sites468→470
2025-10-02
minor
Study Status, Contacts/Locations v29
Study sites468 entries, revised
Velocity Clinical Research-Huntington Park UniversityNewYork-Presbyterian of Florida New YorkBrooklyn Methodist Hospital in Brooklyn Digestive Disease Associates Ziekenhuis Oost-Limburg - Campus Sint-Jan Hospital das Clinicas da Universidade Federal HC-UFMGde Minas Gerais (HCUFMG) PekingCentro Universityde ShenzhenPesquisa HospitalClinica do Brasil Ltda RegionalCentre Hospitalde Médecine Métabolique de Lanaudière Krajska nemocnice Liberec a.s. HOPHopitaux Universitaires Henri Mondor (Hopital Henri-Mondor) Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital Institute of Science Toky [...] [...]
2025-09-17
minor
Study Status, Contacts/Locations v28
Study sites473→468
2025-09-03
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Study Status, Contacts/Locations v27
Study sites484→473
2025-08-20
minor
Study Status, Contacts/Locations v26
Study sites483→484
2025-08-07
minor
Study Status, Study Description v25
Re-verified, no change to tracked fields
2025-08-05
minor
Study Status, Contacts/Locations v24
Study sites483 entries, revised
OfficeResearch ofPhysicians Rukan Daccak, MDNetwork CINME Centro de Investigaciones MetabólicasMetabolicas (CINME)-C.A.B.A-61553
2025-07-25
minor
Study Status, Contacts/Locations v23
Study sites483 entries, revised
Arizona Liver Health - Peoria 85381 EmVenio Research Center at Prime Healthcare- King's Dallas Ogaki MunicipalCollege Hospital Nottingham University Hospitals NHS Trust
2025-07-08
minor
Study Status, Contacts/Locations v22
Study sites482→483
2025-06-24
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Study Status, Contacts/Locations v21
Study sites475→482
2025-06-16
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Study Status, Contacts/Locations v20
Study sites471→475
2025-06-02
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Study Status, Contacts/Locations v19
Study sites460→471
2025-05-15
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Study Status, Contacts/Locations v18
Study sites461→460
2025-04-30
minor
Study Status, Contacts/Locations v17
Study sitesdetails revised at 5 of 461 sites
2025-04-23
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Study Status, Contacts/Locations v16
Study sites404→461
2025-04-12
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Study Identification, Study Status, Outcome Measures, Eligibility, Contacts/Locations v15
Study sites393→404
Eligibility criteria-905 characters
[...] Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score [NAS] ≥4, with at least 1 point in inflammation and ballooning each) and fibrosis stage F2-F3 proven by a biopsy conducted during the screening period or by a historical biopsy conducted within the last 6 months prior to randomisation Stable body weight defined as less than 5% self-reported ch [...] nternational normalised ratio (INR) of prothrombin time >1.3 (unless participant is on anticoagulants) OR total serum bilirubin concentration ≥1.5x ULN (participants with a documented history of Gilbert's syndrome can be enrolled [...] [...]
Secondary endpoints29 entries, revised
Key secondary endpoint part 1: Percentage change from baseline in body weight [kg] Key secondary endpoint part 1: Absolute change from baseline in glycosylated haemoglobin (HbA1c) [%] Key secondary endpoint part 1: Absolute change from baseline in liver stiffness [kPa] assessed by vibration-controlled transient elastography (VCT [...] point part 2: Percentage change from baseline in body weight [kg] Key secondary endpoint part 2: Absolute change from baseline in HbA1c [%] Key secondary endpoint part 2: Absolute change from baseline in liver stiffness [kPa] assessed by VCTE Part 1: Absolute change fro [...] [...]
2025-03-21
minor
Study Status, Contacts/Locations v14
Study sites384→393
2025-03-11
minor
Study Status, Contacts/Locations v13
Study sites413→384
2025-02-27
minor
Study Status, Contacts/Locations v12
Study sites440→413
2025-02-20
minor
Study Status, Contacts/Locations v11
Study sites440 entries, revised
Hopitaux Universitaires Henri Mondor (HopitalHOP Henri-Mondor)
2025-02-12
minor
Study Status, Contacts/Locations v10
Study sites159→440
2025-01-21
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Study Status, Contacts/Locations v9
Study sites136→159
2024-12-20
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Study Status, Contacts/Locations v8
Study sites33→136
2024-12-13
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Study Status, Contacts/Locations v7
Study sites29→33
2024-12-09
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Study Status, Contacts/Locations v6
Study sites21→29
2024-11-27
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Study Status, Contacts/Locations v5
Study sites5→21
2024-11-15
minor
Study Status, Contacts/Locations v4
Study sites1→5
2024-11-12
minor
Study Status, Contacts/Locations v3
Start date2024-10-02→2024-10-14
Study sites4→1
2024-10-31
minor
Study Status, Contacts/Locations v2
Study sites1→4
2024-10-15
minor
Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-10-12→confirmed 2024-10-02
Study sites0→1
This study is open to adults who are at least 18 years old living with obesity and have: * a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and * moderate or advanced liver fibrosis People with a history of acute or chronic liver diseases other than MASH or chronic 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 MASH and moderate or advanced liver fibrosis improve their liver function. This study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving 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. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having 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 and effects on the stomach and intestines are regularly measured. At some visits the liver is measured using different imaging methods. At 2 or 3 visits doctors take a small sample of liver tissue (biopsy). The participants also fill in questionnaires about their symptoms and quality of life. The results are compared between the groups to see whether the treatment works.
Trial Details
NCT Number NCT06632444
Lead Sponsor Boehringer Ingelheim
Conditions Metabolic Dysfunction Associated Steatohepatitis (MASH), Liver Fibrosis
Enrollment 1,800 participants
Start Date 2024-10-14
Primary Completion 2031-12-27 (estimated)
Study Completion 2031-12-27 (estimated)
Updated on ClinicalTrials.gov 2026-10-01