LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
- Conditions
- Metabolic Dysfunction Associated Steatohepatitis (MASH)Liver Fibrosis
- Interventions
- Drug: Placebo
- Registration Number
- NCT06632444
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1800
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Survodutide Survodutide - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Part 1: Resolution of MASH without worsening of liver fibrosis on MASH Clinical Research Network (CRN) fibrosis score Baseline and at Week 52. Part 1: At least a 1-point improvement in fibrosis stage with no worsening of MASH Baseline and at Week 52. 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 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 Outcome Measures
Name Time Method 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) Up to 7 years. Part 1: Improvement of liver fat content (LFC) 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.Part 2: Improvement of LFC 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.Part 2: Absolute change from baseline in LFC [%] in MRI-PDFF At baseline and at Week 114. This endpoint will be reported only for a subset of participants in the MRI sub-study.
Part 2: Absolute change from baseline in systolic blood pressure (SBP) [mmHg] At baseline and at Week 114. Part 1: Absolute change from baseline in diastolic blood pressure (DBP) [mmHg] At baseline and at Week 52. Part 2: Absolute change from baseline in diastolic blood pressure (DBP) [mmHg] At baseline and at Week 114. 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) At baseline and at Week 52. LDL=low-density lipoprotein
Part 1: Progression to cirrhosis (defined as histological fibrosis score CRN F4) (yes/no) At baseline and at Week 52. Key secondary endpoint part 1: Percentage change from baseline in body weight [kg] Baseline and at Week 52. Key secondary endpoint part 1: Absolute change from baseline in liver stiffness [kPa] assessed by vibration-controlled transient elastography (VCTE) Baseline and at Week 52. Key secondary endpoint part 1: Achievement of no progression of fibrosis assessed by central pathology (yes/no) Baseline and at Week 52. Key secondary endpoint part 2: Percentage change from baseline in body weight [kg] At baseline and at Week 114 Key secondary endpoint part 2: Absolute change from baseline in HbA1c [%] At baseline and at Week 114 This endpoint is specified only for the participants with type 2 diabetes mellitus.
Key secondary endpoint part 2: Absolute change from baseline in ELF score At baseline and at Week 114. Key secondary endpoint part 2: Absolute change from baseline in liver stiffness [kPa] assessed by VCTE At baseline and at Week 114. Key secondary endpoint part 2: Achievement of no progression of fibrosis assessed by central pathology (yes/no) At baseline and at 7 years. Key secondary endpoint part 2: Occurrence of all-cause hospitalisation (first and recurrent) Up to 7 years. Part 1: Absolute change from baseline in LFC [%] in MRI-PDFF At baseline and at Week 52. This endpoint will be reported only for a subset of participants in the MRI sub-study.
Part 1: Absolute change from baseline in alanine aminotransferase (ALT) [U/L] At baseline and at Week 52. Part 2: Absolute change from baseline in alanine aminotransferase (ALT) [U/L] At baseline and at Week 114. Part 1: Absolute change from baseline in aspartate aminotransferase (AST) [U/L] At baseline and at Week 52. Part 2: Absolute change from baseline in aspartate aminotransferase (AST) [U/L] At baseline and at Week 114. Part 1: Absolute change from baseline in systolic blood pressure (SBP) [mmHg] At baseline and at Week 52. Part 2: 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) At baseline and at Week 114. Part 1: Absolute change from baseline in free fatty acids [mg/dL] At baseline and at Week 52. Part 2: Absolute change from baseline in free fatty acids [mg/dL] At baseline and at Week 114. Key secondary endpoint part 1: Absolute change from baseline in glycosylated haemoglobin (HbA1c) [%] Baseline and at Week 52. This endpoint is specified only for the participants with type 2 diabetes mellitus.
Key secondary endpoint part 1: Absolute change from baseline in enhanced liver fibrosis (ELF) score Baseline and at Week 52.
Trial Locations
- Locations (468)
Arizona Liver Health - Tucson
🇺🇸Tucson, Arizona, United States
Velocity Clinical Research
🇺🇸Huntington Park, California, United States
Lake Center for Clinical Research
🇺🇸Lady Lake, Florida, United States
CIPREC
🇦🇷Ciudad Autonoma de Buenos Aire, Argentina
Ordensklinikum Linz GmbH
🇦🇹Linz, Austria
Okayama University Hospital
🇯🇵Okayama, Japan
Emc Instytut Medyczny S.A.
🇵🇱Wroclaw, Poland
Fondazione Epatocentro Ticino
🇨🇭Arzo, Switzerland
Uludag Universitesi Tip Fakultesi
🇹🇷Bursa, Turkey
Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
Scroll for more (458 remaining)Arizona Liver Health - Tucson🇺🇸Tucson, Arizona, United StatesBoehringer IngelheimContact833-602-2368unitedstates@bitrialsupport.com