Tests survodutide in adults with liver disease and moderate or advanced liver fibrosis
Tests survodutide weekly injections against placebo in adults with fatty liver disease and scarring.
Key facts
- Who runs it
- Boehringer Ingelheim
- Where
- Changhua, Kaohsiung City, Kaohsuing City, Taichung, Tainan, Taipei, and Taoyuan, TaiwanSee the 11 sitesAlso in 36 other countries, 525 sites
- Trial code
- NCT06632444
- EU 2024-513739-25-00
- U1111-1306-9071
- Registry title
- LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 1,800 people, planned
- Started
- 14 Oct 2024
- Expected to end
- 27 Dec 2031
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Survodutide
- Placebo
- Record updated
- 28 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with the liver disease NASH/MASH and moderate or advanced liver scarring (fibrosis, stage F2 to F3). It tests the medicine survodutide against a placebo.
- Age
- 18 years or older (or the legal adult age where that is higher than 18)
- Sex
- Men and women
- Disease stage
- NASH/MASH with a NAS (NAFLD activity score) of 4 or more; moderate or advanced liver fibrosis (F2 to F3); no cirrhosis (F4)
Main reasons for not taking part
- Any acute or chronic liver disease other than MASH
- Cirrhosis (fibrosis stage F4) shown on a biopsy
- History of or current liver cancer (hepatocellular carcinoma), or a history of or planned liver transplant
- Portal hypertension or decompensated liver disease
- Cannot or will not have a liver biopsy
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
- Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score [NAS] ≥4
- 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
- Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further inclusion criteria apply
Who cannot take part
- Any history or evidence of acute or chronic liver disease other than MASH
- History of or current diagnosis of hepatocellular carcinoma
- History of or planned liver transplant
- History of portal hypertension or presence of decompensated liver disease
- Model for end-stage liver disease (MELD) score ≥12 due to liver disease. Further exclusion criteria apply
- 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
- Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy
- Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct
Where in Taiwan
Also in 36 other countries, 525 sites
- Changhua Christian HospitalChanghua, TaiwanContact: Boehringer IngelheimTaking people
- E-DA HospitalKaohsiung City, TaiwanContact: Boehringer IngelheimTaking people
- Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsuing City, TaiwanContact: Boehringer IngelheimTaking people
- Chung Shan Medical University HospitalTaichung, TaiwanContact: Boehringer IngelheimTaking people
- Taichung Veterans General HospitalTaichung, TaiwanContact: Boehringer IngelheimTaking people
- Chi Mei Medical CenterTainan, TaiwanContact: Boehringer IngelheimTaking people
- National Cheng Kung University HospitalTainan, TaiwanContact: Boehringer IngelheimTaking people
- National Taiwan University HospitalTaipei, TaiwanContact: Boehringer IngelheimTaking people
- Taipei Medical University HospitalTaipei, TaiwanContact: Boehringer IngelheimTaking people
- Taipei Veterans General HospitalTaipei, TaiwanContact: Boehringer IngelheimTaking people
- Chang Gung Medical Foundation (CGMF) - Linkou BranTaoyuan, TaiwanContact: Boehringer IngelheimTaking people
About the trial
What the trial wants to find out
This study is open to adults who are at least 18 years old living with obesity and have:
Read full original descriptionShow less
* 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.
The 2 groups in the trial
- SurvodutideTreatment being tested
- PlaceboPlacebo, for comparison
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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
- Plain-language title
- Tests survodutide in adults with liver disease and moderate or advanced liver fibrosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 28 October 2026