LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
Launched by BOEHRINGER INGELHEIM · Oct 8, 2024
Trial Information
Current as of May 20, 2025
Recruiting
Keywords
ClinConnect Summary
The LIVERAGE™ study is researching whether a medication called survodutide can help adults with a liver disease known as non-alcoholic steatohepatitis (NASH) or metabolic-associated steatohepatitis (MASH) who also have cirrhosis, which is a serious condition where the liver becomes damaged. To participate, individuals must be at least 18 years old, have a body mass index (BMI) of 27 or higher (or 25 for Asian participants), and cannot have a history of significant alcohol use or other chronic liver diseases.
During the study, participants will be randomly assigned to receive either the medication or a placebo (which looks like the medication but has no active ingredients). They will inject the treatment once a week and will receive support for lifestyle changes like diet and exercise. The study lasts up to 4.5 years, with regular check-ins to monitor health and any side effects. This research aims to determine if survodutide can improve liver function and overall health for those living with these conditions.
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • 1. Male or female adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is \>18 years
- • 2. Body mass index (BMI) ≥27 kg/m2(≥25 kg/m2 for Asian trial participants)
- • 3. Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis.
- • 4. Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5% or FibroScan® with controlled attenuation parameter (CAP) ≥288 dB/m, obtained during the screening period or a historic MRI-PDFF ≤12 weeks prior to randomisation (except for patients with 'cryptogenic cirrhosis' where MRI-PDFF \<5% or FibroScan® with CAP \<288 dB/m is allowed). This inclusion criterion does not apply for participants with a recent (≤12 months prior to randomisation) liver biopsy showing steatosis/steatohepatitis.
- • 5. Further inclusion criteria apply.
- Exclusion criteria:
- • 1. Current or history (\<5 years) of significant alcohol consumption, defined as an average of \>140 g/week in female patients and \>210 g/week in male patients, for a period of \>3 consecutive months, or an inability to reliably quantify alcohol consumption based upon judgment of the investigator.
- • 2. Model of end-stage liver Disease (MELD) score \>12 due to liver disease
- 3. History or current (i.e. at screening) hepatic decompensation event of any of the following but not limited to:
- • Portal hypertension-related upper gastrointestinal (GI) bleeding
- • Ascites
- • Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria
- • 4. Any of the following lab test result at screening
- • Albumin below \<3.5 g/dL (\<35.0 g/L)
- • International normalised ratio (INR) \>1.3 unless due to therapeutic anticoagulants
- • Total bilirubin (TBL) \>1.2x upper limit of normal (ULN) NOTE: Trial participants with Gilbert Syndrome are eligible with a TBL \>1.2x ULN if reticulocyte count is within normal limits, haemoglobin is within normal limits unless due to chronic anaemia and unrelated to haemolysis, and direct bilirubin is \<20% of TBL.
- • Alkaline phosphatase \>1.5x ULN
- • PLT \<90,000/µL (\<90 GI/L)
- • 5. History or evidence of other chronic liver diseases, such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1-antitrypsin deficiency, or genetic haemochromatosis
- • 6. Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg)) or history of chronic HBV infection
- • 7. Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA))
- • 8. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>5x ULN
- • 9. Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history
- • 10. History of liver transplantation or listed for liver transplantation
- • 11. History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological/surgical procedure for portal hypertension treatment
- • 12. Further exclusion criteria apply
About Boehringer Ingelheim
Boehringer Ingelheim is a global, research-driven pharmaceutical company dedicated to improving health and quality of life through innovative therapies. Established in 1885 and headquartered in Ingelheim, Germany, the company focuses on the development of prescription medicines in key therapeutic areas, including respiratory diseases, cardiovascular health, oncology, and immunology. Boehringer Ingelheim is committed to advancing medical science through rigorous clinical trials and collaborative research, striving to bring novel treatments to patients while upholding the highest standards of safety and efficacy. With a strong emphasis on sustainability and corporate responsibility, the company aims to make a meaningful impact on global health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Rochester, New York, United States
Westmead, New South Wales, Australia
Liverpool, New South Wales, Australia
Parkville, Victoria, Australia
Madrid, , Spain
Perth, Western Australia, Australia
Atlanta, Georgia, United States
Houston, Texas, United States
Concord, New South Wales, Australia
Miami, Florida, United States
Omaha, Nebraska, United States
Rozzano (Mi), , Italy
Singapore, , Singapore
London, , United Kingdom
London, , United Kingdom
Singapore, , Singapore
Madrid, , Spain
Raleigh, North Carolina, United States
Singapore, , Singapore
Hershey, Pennsylvania, United States
Aberdeen, , United Kingdom
Bologna, , Italy
Omaha, Nebraska, United States
Berlin, , Germany
Heidelberg, Victoria, Australia
Hull, , United Kingdom
Lübeck, , Germany
Kingswood, New South Wales, Australia
Zephyrhills, Florida, United States
Beijing, , China
Ulm, , Germany
Heidelberg, , Germany
Le Chesnay, , France
Münster, , Germany
Macon, Georgia, United States
Beijing, , China
Magdeburg, , Germany
Manassas, Virginia, United States
Summerville, South Carolina, United States
Seoul, , Korea, Republic Of
Freiburg, , Germany
Chengdu, , China
Nashville, Tennessee, United States
Derby, , United Kingdom
Seoul, , Korea, Republic Of
Shreveport, Louisiana, United States
Cambridge, , United Kingdom
Tulsa, Oklahoma, United States
Chiba, , Japan
Kobe, , Japan
Seoul, , Korea, Republic Of
Santiago De Compostela, , Spain
Shanghai, , China
Tampa, Florida, United States
Monroe, Louisiana, United States
Chattanooga, Tennessee, United States
Liège, , Belgium
Columbus, Ohio, United States
Mainz, , Germany
London, , United Kingdom
Taichung City, , Taiwan
Toronto, Ontario, Canada
Wels, , Austria
Ishikawa, Kanazawa, , Japan
Cambridge, , United Kingdom
Southport, Queensland, Australia
Shanghai, , China
Shanghai, , China
Incheon, , Korea, Republic Of
Arlington, Texas, United States
Changchun, , China
Merida, , Mexico
Hamilton, Waikato, New Zealand
Guangzhou, , China
Edegem, , Belgium
Nottingham, , United Kingdom
Iasi, , Romania
Nanjing, , China
Wuhan, , China
Wakayama, , Japan
Las Vegas, Nevada, United States
Seoul, , Korea, Republic Of
Christchurch, Canterbury, New Zealand
Greenville, North Carolina, United States
Taipei City, , Taiwan
Coronado, California, United States
Nanchang, , China
Seoul, , Korea, Republic Of
Napoli, , Italy
Padova, , Italy
Munster, Indiana, United States
Ramos Mejía, , Argentina
Beijing, , China
Shanghai, , China
Fukui, Fukui, , Japan
Mentor, Ohio, United States
San Juan, , Puerto Rico
Mannheim, , Germany
A Coruña, , Spain
Majadahonda, , Spain
Columbus, Ohio, United States
Nanchang, , China
Yinchuan, , China
Tokyo, Bunkyo Ku, , Japan
Myslowice, , Poland
Linz, , Austria
Genk, , Belgium
Wien, , Austria
Seoul, , Korea, Republic Of
Krakow, , Poland
Kuala Lumpur, , Malaysia
Palermo, , Italy
Roma, , Italy
San Juan, , Puerto Rico
Taichung City, , Taiwan
Taipei City, , Taiwan
West Des Moines, Iowa, United States
Xi'an, , China
Seoul, , Korea, Republic Of
Vienna, , Austria
Tokyo, Bunkyo Ku, , Japan
Homburg, , Germany
Southampton, , United Kingdom
Pilar, , Argentina
Shanghai, , China
Vina Del Mar, , Chile
Papatoetoe, Auckland, New Zealand
Seoul, , Korea, Republic Of
Clayton, Victoria, Australia
Orlando, Florida, United States
Gifu, Ogaki, , Japan
Shenyang, , China
Sao Jose Do Rio Preto, , Brazil
Tokyo, Shinjuku Ku, , Japan
Hangzhou, , China
Hangzhou, , China
Roma, , Italy
Fukuoka, Fukuoka, , Japan
Osaka, Suita, , Japan
Tarragona, , Spain
Hokkaido, Sapporo, , Japan
New York, New York, United States
Tokyo, Minato Ku, , Japan
Nara, Kashihara, , Japan
Izmir, , Turkey
London, , United Kingdom
Shinjuku Ku, , Japan
Seoul, , Korea, Republic Of
Zuerich, , Switzerland
Palmetto Bay, Florida, United States
Kumamoto, Kumamoto, , Japan
Würzburg, , Germany
Canoga Park, California, United States
Gainesville, Georgia, United States
Wonju Si, , Korea, Republic Of
San Juan, , Puerto Rico
Dresden, , Germany
Fukuoka, Kurume, , Japan
Shizuoka, Hamamatsu, , Japan
Kanagawa, Kawasaki, , Japan
San Antonio, Texas, United States
Pontevedra, , Spain
Kagoshima, Kagoshima, , Japan
Aberdeen, , United Kingdom
Birmingham, , United Kingdom
Taipei City, , Taiwan
Beijing, , China
Dallas, Texas, United States
Tianjin, , China
Surat, , India
Warszawa, , Poland
Rialto, California, United States
Surat, , India
Busan, , Korea, Republic Of
Edinburg, Texas, United States
Izumo, , Japan
Coral Gables, Florida, United States
Cutler Bay, Florida, United States
South Bend, Indiana, United States
Marrero, Louisiana, United States
Las Vegas, Nevada, United States
Nishinomiya, , Japan
Yokohama, , Japan
Houston, Texas, United States
Changsha, , China
Fuzhou, , China
Nagasaki, Omura, , Japan
Winter Park, Florida, United States
Jiaxing, , China
Bridgewater, Nova Scotia, Canada
Wyomissing, Pennsylvania, United States
Las Vegas, Nevada, United States
Bochum, , Germany
Tainan City, , Taiwan
Oxford, , United Kingdom
Kita Gun, , Japan
Birmingham, , United Kingdom
Miami, Florida, United States
Wyomissing, Pennsylvania, United States
Clichy Sous Bois, , France
Isehara, , Japan
Seoul, , Korea, Republic Of
Lancaster, California, United States
Liaocheng, , China
Beijing, , China
Okayama, Kurashiki, , Japan
Raleigh, North Carolina, United States
Oxnard, California, United States
Wyoming, Michigan, United States
Pingxiang, , China
Hangzhou, , China
Kyoto, Kyoto, , Japan
San Juan, , Puerto Rico
Istanbul, , Turkey
Xi'an, , China
Ibaraki, Inashiki Gun, , Japan
Sakai, , Japan
Bunkyo Ku, , Japan
Lugano, , Switzerland
Ehime, Toon, , Japan
Kagawa, Takamatsu, , Japan
Nagano, Matsumoto, , Japan
Ampang Jaya, , Malaysia
Fatih, , Turkey
Austin, Texas, United States
Miami, Florida, United States
Stara Zagora, , Bulgaria
Ankara, , Turkey
Waco, Texas, United States
Clarksville, Tennessee, United States
Bursa, , Turkey
Hialeah Gardens, Florida, United States
Sofia, , Bulgaria
Plzen, , Czechia
Orlando, Florida, United States
Anderlecht, , Belgium
Kelantan, , Malaysia
Kunming, , China
Nanjing, , China
Osaka, Suita, , Japan
Saga, Saga, , Japan
Shizuoka, Izunokuni, , Japan
Minneapolis, Minnesota, United States
Colorado Springs, Colorado, United States
Lewisville, Texas, United States
Homestead, Florida, United States
La Mesa, California, United States
Shenzhen, , China
San Diego, California, United States
Miami, Florida, United States
Poway, California, United States
Dallas, Texas, United States
Miami, Florida, United States
Roma, , Italy
Denison, Texas, United States
Bucheon Si, , Korea, Republic Of
Wiesbaden, , Germany
Mie, Tsu, , Japan
Grafton, Auckland, New Zealand
Dallas, Texas, United States
Orange, California, United States
Saint Petersburg, Florida, United States
Kure, , Japan
Johannesburg, , South Africa
Brooksville, Florida, United States
Graz, , Austria
Luoyang, , China
Orpington, , United Kingdom
Cluj Napoca, , Romania
Preston, , United Kingdom
Georgetown, Texas, United States
Glasgow, , United Kingdom
Hangzhou, , China
The Villages, Florida, United States
Geneve, , Switzerland
Northwood, , United Kingdom
Inglewood, California, United States
Sheffield, , United Kingdom
Hialeah, Florida, United States
Tampa, Florida, United States
Tbilisi, , Georgia
Richmond, Virginia, United States
Hiroshima, Hiroshima, , Japan
San Bernardino, California, United States
Scottsdale, Arizona, United States
Tainan City, , Taiwan
Batumi, , Georgia
Austin, Texas, United States
Austin, Texas, United States
Lublin, , Poland
Draper, Utah, United States
Sofia, , Bulgaria
Ankara, , Turkey
Cluj Napoca, , Romania
Surat, , India
Nanjing, , China
Kanpur, , India
Takasaki, , Japan
Orlando, Florida, United States
Clinton Township, Michigan, United States
Fountain Valley, California, United States
Wrocław, , Poland
Wuhan, , China
Tokyo, Bunkyo Ku, , Japan
Lodz, , Poland
Lady Lake, Florida, United States
Springboro, Ohio, United States
Miami, Florida, United States
Córdoba, , Spain
Huntington Park, California, United States
La Mesa, California, United States
Montclair, California, United States
Fort Myers, Florida, United States
Warren, New Jersey, United States
Medford, Oregon, United States
Seattle, Washington, United States
Spokane, Washington, United States
Brandon, Florida, United States
Miramar, Florida, United States
Mcallen, Texas, United States
San Antonio, Texas, United States
Ogden, Utah, United States
Chula Vista, California, United States
Bradenton, Florida, United States
Oita, , Japan
łódź, , Poland
Flagstaff, Arizona, United States
Tucson, Arizona, United States
Poway, California, United States
Englewood, Colorado, United States
Bristol, Connecticut, United States
Hialeah, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Monroe, Louisiana, United States
Minneapolis, Minnesota, United States
Kansas City, Missouri, United States
Inwood, New York, United States
Westlake, Ohio, United States
Flourtown, Pennsylvania, United States
Columbia, South Carolina, United States
Brownsville, Texas, United States
Pasadena, Texas, United States
San Antonio, Texas, United States
Wichita Falls, Texas, United States
Seoul, , Korea, Republic Of
Sarasota, Florida, United States
Milano, , Italy
Columbia, Missouri, United States
Ciudad Autónoma De Buenos Aires, , Argentina
Guildford, , United Kingdom
Garland, Texas, United States
Mesquite, Texas, United States
Buenos Aires, , Argentina
Ciudad Autónoma De Buenos Aires, , Argentina
Florencio Varela, , Argentina
Belem, , Brazil
Cerqueira Cesar, , Brazil
Porto Alegre, , Brazil
Porto Alegre, , Brazil
Gorna Oryahovitsa, , Bulgaria
Panagyurishte, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Montreal, Quebec, Canada
Quebec, , Canada
La Serena, , Chile
Brno Zidenice, , Czechia
Liberec, , Czechia
Praha 2, , Czechia
Frankfurt, , Germany
Köln Lindenthal, , Germany
Budapest, , Hungary
Budapest, , Hungary
Ahemdabad, , India
Chandigarh, , India
Hyderabad, , India
Jaipur, , India
Jaipur, , India
Lucknow, , India
Nagpur, , India
New Delhi, , India
Rohtak, , India
Secunderabad, , India
Modena, , Italy
Turin, , Italy
Gifu, Gifu, , Japan
Hanishina Gun, , Japan
Hokkaido, Sapporo, , Japan
Kumamoto, Kumamoto, , Japan
Miyazaki, Miyazaki, , Japan
Sakai, , Japan
Sendai Shi, , Japan
Tokyo, Musashino, , Japan
Putrajaya, , Malaysia
Acapulco De Juarez, , Mexico
Benito Juarez, Mexico, , Mexico
Mexico City, , Mexico
Veracruz, , Mexico
Lublin, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Bucuresti, , Romania
Ramah, , Saudi Arabia
Riyadh, , Saudi Arabia
Plumstead, , South Africa
Changhua City, , Taiwan
Kaohsuing City, , Taiwan
Taoyuan City, , Taiwan
Ankara, , Turkey
Bahcelievler, , Turkey
Rize, , Turkey
Acomb, York, , United Kingdom
Bristol, , United Kingdom
Dagenham, , United Kingdom
Enfield, , United Kingdom
Exeter, , United Kingdom
Frimley, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Newcastle, , United Kingdom
Portsmouth, , United Kingdom
Rochdale, , United Kingdom
Stockton On Tees, , United Kingdom
Wallasey, , United Kingdom
Qingdao, , China
Santiago, , Chile
Guangzhou, , China
Ningbo, , China
Suzhou, , China
Zhejiang, , China
Côte D'or, , France
Haute Garonne, , France
Maine Et Loire, , France
Nord Pas De Calais, , France
Paris, , France
Tbilisi, , Georgia
Dresden, , Germany
Ahemdabad, , India
Roma, , Italy
Benito Juarez, Mexico, , Mexico
Mexico City, , Mexico
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Bucuresti, , Romania
Ramah, , Saudi Arabia
Ankara, , Turkey
Riverdale, Georgia, United States
Bellaire, Texas, United States
Farmers Branch, Texas, United States
Houston, Texas, United States
Waco, Texas, United States
Roma, , Italy
Putrajaya, , Malaysia
Lyon, , France
île De France, , France
San Juan, , Puerto Rico
Palermo, , Italy
Miami, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Hammond, Indiana, United States
Brooklyn, New York, United States
Mcallen, Texas, United States
Zhenjiang, , China
Kanpur, , India
Tokyo, Bunkyo Ku, , Japan
Amman, , Jordan
Jordan, , Jordan
San Juan, , Puerto Rico
Bucuresti, , Romania
Changzhou Shi, , China
Bucuresti, , Romania
Berlin, , Germany
Guangzhou, , China
Zhengzhou, , China
Osaka, Suita, , Japan
Tianjin Shi, , China
Roma, , Italy
Fort Worth, Texas, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported