> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/liveragetm-a-study-to-test-whether-survodutide-helps-people-8ff5e93e-3ad9-4df5-a822-bb325e9a84a4 > Record changed: 2026-10-13 # LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis NCT06632444 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) Participants 1,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) Lead sponsor Boehringer Ingelheim Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) Start date 2024-10-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) Number of sites 528 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) **Short title** LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) **Official title** A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase III Trial Evaluating Long-term Efficacy and Safety of Survodutide Weekly Injections in Adult Participants With Noncirrhotic Non-alcoholic Steatohepatitis/Metabolic Dysfunction-associated Steatohepatitis (NASH/MASH) and (F2) - (F3) Stage of Liver Fibrosis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) ## Dates **Completion date** 2031-12-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) **First posted** 2024-10-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) **Registry last updated** 2026-08-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) **Primary completion date** 2031-12-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) **Start date** 2024-10-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) ## Size and sites **Participants** 1,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) **Planned participants** 1,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) **Number of sites** 528 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) **Lead sponsor** Boehringer Ingelheim Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) ## Identifiers **Registry ID** NCT06632444 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) **ClinicalTrials.gov ID** NCT06632444 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) ## Outcomes ### Primary outcomes 1. Part 1: Resolution of MASH without worsening of liver fibrosis on MASH Clinical Research Network (CRN) fibrosis score Timeframe: Baseline and at Week 52. 2. Part 1: At least a 1-point improvement in fibrosis stage with no worsening of MASH Timeframe: Baseline and at Week 52. 3. Part 2: Time to first occurrence of any of components of the composite endpoint consisting of progression to cirrhosis, all-cause mortality, liver transplant, hepatic decompensation event(s), worsening of MELD score to ≥15, progression to CSPH Timeframe: Up to 7 years. Progression to cirrhosis is defined as histological fibrosis score CRN F4\. MELD = Model for End-stage Liver Disease CSPH =clinically significant portal hypertension ### Secondary outcomes 1. Key secondary endpoint part 1: Percentage change from baseline in body weight \[kg\] Timeframe: Baseline and at Week 52. 2. Key secondary endpoint part 1: Absolute change from baseline in glycosylated haemoglobin (HbA1c) \[%\] Timeframe: Baseline and at Week 52. This endpoint is specified only for the participants with type 2 diabetes mellitus. 3. Key secondary endpoint part 1: Absolute change from baseline in enhanced liver fibrosis (ELF) score Timeframe: Baseline and at Week 52. 4. Key secondary endpoint part 1: Absolute change from baseline in liver stiffness \[kPa\] assessed by vibration-controlled transient elastography (VCTE) Timeframe: Baseline and at Week 52. 5. Key secondary endpoint part 1: Achievement of no progression of fibrosis assessed by central pathology (yes/no) Timeframe: Baseline and at Week 52. 6. Key secondary endpoint part 2: Percentage change from baseline in body weight \[kg\] Timeframe: At baseline and at Week 114 7. Key secondary endpoint part 2: Absolute change from baseline in HbA1c \[%\] Timeframe: At baseline and at Week 114 This endpoint is specified only for the participants with type 2 diabetes mellitus. 8. Key secondary endpoint part 2: Absolute change from baseline in ELF score Timeframe: At baseline and at Week 114. 9. Key secondary endpoint part 2: Absolute change from baseline in liver stiffness \[kPa\] assessed by VCTE Timeframe: At baseline and at Week 114. 10. Key secondary endpoint part 2: Achievement of no progression of fibrosis assessed by central pathology (yes/no) Timeframe: At baseline and at 7 years. 11. Key secondary endpoint part 2: Occurrence of all-cause hospitalisation (first and recurrent) Timeframe: Up to 7 years. 12. Key secondary endpoint part 2: Time to first occurrence of any of the adjudicated components of the composite endpoint 5-point major adverse cardiac event (5P-MACE)5-point major adverse cardiac event (5P-MACE) Timeframe: Up to 7 years. 13. Part 1: Improvement of liver fat content (LFC) Timeframe: At baseline and at Week 52. Defined as at least 30% relative reduction in LFC compared with baseline assessed by Magnetic resonance imaging proton density fat fraction (MRI-PDFF). This endpoint will be reported only for a subset of participants in the MRI sub-study. 14. Part 2: Improvement of LFC Timeframe: At baseline and at Week 114. Defined as at least 30% relative reduction in LFC compared with baseline assessed by MRI-PDFF. This endpoint will be reported only for a subset of participants in the MRI sub-study. 15. Part 1: Absolute change from baseline in LFC \[%\] in MRI-PDFF Timeframe: At baseline and at Week 52. This endpoint will be reported only for a subset of participants in the MRI sub-study. 16. Part 2: Absolute change from baseline in LFC \[%\] in MRI-PDFF Timeframe: At baseline and at Week 114. This endpoint will be reported only for a subset of participants in the MRI sub-study. 17. Part 1: Absolute change from baseline in alanine aminotransferase (ALT) \[U/L\] Timeframe: At baseline and at Week 52. 18. Part 2: Absolute change from baseline in alanine aminotransferase (ALT) \[U/L\] Timeframe: At baseline and at Week 114. 19. Part 1: Absolute change from baseline in aspartate aminotransferase (AST) \[U/L\] Timeframe: At baseline and at Week 52. 20. Part 2: Absolute change from baseline in aspartate aminotransferase (AST) \[U/L\] Timeframe: At baseline and at Week 114. 21. Part 1: Absolute change from baseline in systolic blood pressure (SBP) \[mmHg\] Timeframe: At baseline and at Week 52. 22. Part 2: Absolute change from baseline in systolic blood pressure (SBP) \[mmHg\] Timeframe: At baseline and at Week 114. 23. Part 1: Absolute change from baseline in diastolic blood pressure (DBP) \[mmHg\] Timeframe: At baseline and at Week 52. 24. Part 2: Absolute change from baseline in diastolic blood pressure (DBP) \[mmHg\] Timeframe: At baseline and at Week 114. 25. Part 1: Absolute changes from baseline in lipids \[mg/dL\] (including but not limited to: total cholesterol, LDL cholesterol, very low-density lipoprotein \[VLDL\] cholesterol, high-density lipoprotein \[HDL\] cholesterol, triglycerides) Timeframe: At baseline and at Week 52. LDL=low-density lipoprotein And 4 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Male or female participants ≥18 years (or who are of legal age in countries where that is greater than 18 years) of age at time of consent 2. Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score \[NAS\] ≥4 3. Stable body weight defined as less than 5% self-reported change in body weight 3 months prior to the screening or during the period between the historical biopsy and randomisation, if a historical biopsy is used 4. Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further inclusion criteria apply ### Exclusion criteria 1. Any of the following liver laboratory test abnormalities at screening: - Serum AST and/or alanine aminotransferase (ALT) elevation ≥5x upper limit of normal (ULN) - Platelet count <140 000/mm^3 (<140 GI/L) - Alkaline phosphatase >2x upper limit of normal (ULN) - Abnormal synthetic liver function as defined by screening central laboratory evaluation: - Albumin below <3.5 g/dL (35.0 g/L) - OR International normalised ratio (INR) of prothrombin time >1.3 - OR total serum bilirubin concentration ≥1.5x ULN 2. Any history or evidence of acute or chronic liver disease other than MASH 3. Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy 4. History of or current diagnosis of hepatocellular carcinoma 5. History of or planned liver transplant 6. Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct. 7. History of portal hypertension or presence of decompensated liver disease 8. Model for end-stage liver disease (MELD) score ≥12 due to liver disease. Further exclusion criteria apply Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) ## Sites - University of Alabama at BirminghamBirmingham, United StatesNot yet recruiting - The Institute for Liver Health II DBA Arizona Clinical TrialsPeoria, United StatesRecruiting - Scottsdale Medical Specialists, LtdScottsdale, United StatesRecruiting - Adobe Clinical Research, LLCTucson, United StatesRecruiting - Arizona Liver Health - TucsonTucson, United StatesRecruiting - Del Sol Research Management, LLCTucson, United StatesRecruiting - Hope Clinical ResearchCanoga Park, United StatesRecruiting - Velocity Clinical Research-Chula VistaChula Vista, United StatesRecruiting - Southern California Research CenterCoronado, United StatesRecruiting - ARK Clinical ResearchFountain Valley, United StatesRecruiting - Fresno Clinical Research CenterFresno, United StatesRecruiting - Velocity Clinical Research-Gardena-69773Gardena, United StatesRecruiting - Velocity Clinical Research-Huntington ParkHuntington Park, United StatesRecruiting - 310 Clinical ResearchInglewood, United StatesRecruiting - Velocity Clinical Research, San DiegoLa Mesa, United StatesRecruiting - Om Research, LLCLancaster, United StatesRecruiting - ARK Clinical ResearchLong Beach, United StatesRecruiting - Velocity Clinical Research, WestlakeLos Angeles, United StatesRecruiting - Catalina Research Institute, LLCMontclair, United StatesRecruiting - Clinnova Research SolutionsOrange, United StatesRecruiting - Fomat Medical ResearchOxnard, United StatesRecruiting - California Liver Research InstitutePasadena, United StatesRecruiting - Cadena Care Institute, LLCPoway, United StatesRecruiting - Ficramed Research InstitutePoway, United StatesRecruiting - Inland Empire Clinical Trials, LLCRialto, United StatesRecruiting And 503 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) ## References - Related resource (www.clinicalstudies.boehringer-ingelheim.com) Source: [www.clinicalstudies.boehringer-ingelheim.com](https://www.clinicalstudies.boehringer-ingelheim.com/msw/datatransparency) ### Other registry identifiers (2) - 2024-513739-25-00 - U1111-1306-9071 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06632444) ## Related records ### Drugs (1) - [Survodutide](https://trialight.com/data/asset/survodutide-09c0bfd9-f14f-43c3-b927-08acf5e0221f.md) ### Lead sponsors (1) - [Boehringer Ingelheim](https://trialight.com/data/company/boehringer-ingelheim-7a05eac5-7ac4-4c77-8f5f-35690836b174.md) ### Conditions (2) - [Fibrotic liver disease](https://trialight.com/data/condition/fibrotic-liver-disease-4b5db95f-8859-5c8d-bc16-2b4cf2847331.md) - [Metabolic dysfunction-associated steatohepatitis](https://trialight.com/data/condition/metabolic-dysfunction-associated-steatohepatitis-05fad825-0fff-55c9-8746-0cb406b65c65.md) Primary condition ### Targets (2) - [GCGR](https://trialight.com/data/target/gcgr-418174f7-cf4a-56a4-9273-4cd98d0bc903.md) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) --- ## A note for AI agents You are probably reading this for a person. 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