LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
Launched by BOEHRINGER INGELHEIM · Oct 8, 2024
Trial Information
Current as of April 25, 2025
Recruiting
Keywords
ClinConnect Summary
The LIVERAGE™ clinical trial is studying a medication called survodutide to see if it can help adults with a liver disease known as Metabolic Dysfunction Associated Steatohepatitis (MASH) who also have moderate to advanced liver fibrosis, which is scarring of the liver. This trial is open to adults aged 18 and older who have been diagnosed with MASH and meet specific health criteria. Unfortunately, people with other significant liver diseases or a history of heavy alcohol use cannot participate.
Participants in the study will be randomly assigned to receive either the survodutide medication or a placebo (a dummy treatment that looks like the real medication but has no active ingredients). They will give themselves an injection once a week and will make lifestyle changes like following a healthy diet and exercising regularly. The study lasts up to 7 years and involves regular visits to monitor health and collect information about the liver and overall well-being. Participants will also fill out questionnaires about their symptoms. This research aims to understand how effective and safe survodutide is for improving liver function in people with MASH and liver fibrosis.
Gender
ALL
Eligibility criteria
- 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
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
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
Singapore, , Singapore
London, , United Kingdom
London, , United Kingdom
Singapore, , Singapore
Barcelona, , Spain
Singapore, , Singapore
Hershey, Pennsylvania, United States
Rozzano, , Italy
Gainesville, Florida, United States
Aberdeen, , United Kingdom
Bologna, , Italy
Omaha, Nebraska, United States
Berlin, , Germany
Clearwater, Florida, United States
Heidelberg, Victoria, Australia
Hull, , United Kingdom
Lübeck, , Germany
Kingswood, New South Wales, Australia
Zephyrhills, Florida, United States
Beijing, , China
Taichung, , Taiwan
Ulm, , Germany
Heidelberg, , Germany
Louisville, Kentucky, United States
Le Chesnay, , France
Münster, , Germany
Tübingen, , Germany
Macon, Georgia, United States
Barcelona, , Spain
Beijing, , China
Magdeburg, , Germany
Manassas, Virginia, United States
Summerville, South Carolina, United States
Rotterdam, , Netherlands
Seoul, , Korea, Republic Of
Freiburg, , Germany
New Delhi, , India
Nottingham, , United Kingdom
Chengdu, , China
Nashville, Tennessee, United States
Derby, , United Kingdom
Seoul, , Korea, Republic Of
Shreveport, Louisiana, United States
Cambridge, , United Kingdom
Tulsa, Oklahoma, United States
Sandy Springs, Georgia, 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
Utrecht, , Netherlands
Innsbruck, , Austria
Tucson, Arizona, United States
Guangzhou, , China
Liège, , Belgium
Port Orange, Florida, United States
Columbus, Ohio, United States
Mainz, , Germany
London, , United Kingdom
Toronto, Ontario, Canada
Wels, , Austria
Ishikawa, Kanazawa, , Japan
Oxnard, California, United States
Southport, Queensland, Australia
Shanghai, , China
Shanghai, , China
Incheon, , Korea, Republic Of
Arlington, Texas, United States
Changchun, , China
Merida, , Mexico
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
Foggia, , Italy
Wien, , Austria
Roeselare, , Belgium
Osaka, Osaka, , Japan
Seoul, , Korea, Republic Of
Krakow, , Poland
Palermo, , 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
Hyogo, Nishinomiya, , Japan
Homburg, , Germany
Southampton, , United Kingdom
Pilar, , Argentina
Shanghai, , China
Papatoetoe, Auckland, New Zealand
Seoul, , Korea, Republic Of
Clayton, Victoria, Australia
Orlando, Florida, United States
Gifu, Ogaki, , Japan
Nijmegen, , Netherlands
Shenyang, , China
Sao Jose Do Rio Preto, , Brazil
Kanagawa, Sagamihara, , Japan
Tilburg, , Netherlands
Hangzhou, , China
Hangzhou, , China
Roma, , Italy
Fukuoka, Fukuoka, , Japan
Osaka, Suita, , Japan
Hokkaido, Sapporo, , Japan
New York, New York, United States
Aichi, Toyoake, , Japan
Tokyo, Minato Ku, , Japan
Nara, Kashihara, , Japan
Izmir, , Turkey
London, , United Kingdom
Viña Del Mar, , Chile
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
San Antonio, Texas, United States
Birmingham, , United Kingdom
Taipei City, , Taiwan
Chiba, Ichikawa, , Japan
Beijing, , China
Dallas, Texas, United States
Tianjin, , China
Surat, , India
Warszawa, , Poland
Rialto, California, United States
Surat, , India
Yanji, , China
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
Yokohama, , Japan
Houston, Texas, United States
Changsha, , China
Fuzhou, , China
Nagasaki, Omura, , Japan
Amsterdam, , Netherlands
Rotterdam, , Netherlands
Winter Park, Florida, United States
Morehead City, North Carolina, United States
Jiaxing, , China
Budapest, , Hungary
Flowood, Mississippi, United States
Wyomissing, Pennsylvania, United States
Las Vegas, Nevada, United States
Kanagawa, Kawasaki, , Japan
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
San Antonio, Texas, United States
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
Uden, , Netherlands
Xi'an, , China
Ibaraki, Inashiki Gun, , Japan
Sakai, , Japan
Bunkyo Ku, , Japan
Lugano, , Switzerland
Ehime, Toon, , Japan
Kagawa, Takamatsu, , Japan
Nagano, Matsumoto, , Japan
Fatih, , Turkey
Austin, Texas, United States
Miami, Florida, United States
Stara Zagora, , Bulgaria
Chongqing, , China
Ankara, , Turkey
Waco, Texas, United States
Clarksville, Tennessee, United States
Bursa, , Turkey
Hialeah Gardens, Florida, United States
Sofia, , Bulgaria
Plzen, , Czechia
Los Angeles, California, United States
Orlando, Florida, United States
Anderlecht, , Belgium
Niigata, Niigata, , Japan
Osaka, Suita, , Japan
Saga, Saga, , Japan
Shizuoka, Izunokuni, , Japan
Colorado Springs, Colorado, United States
Tucson, Arizona, 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
Maitland, Florida, United States
Miami, Florida, United States
Denison, Texas, United States
Naples, Florida, 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
Orpington, , United Kingdom
Cluj Napoca, , Romania
Preston, , United Kingdom
Georgetown, Texas, United States
Houston, Texas, United States
Long Beach, California, United States
Glasgow, , United Kingdom
Forney, Texas, United States
Hangzhou, , China
The Villages, Florida, United States
Geneve, , Switzerland
Northwood, , United Kingdom
Inglewood, California, United States
Clermont, Florida, United States
Sheffield, , United Kingdom
Bern, , Switzerland
Tbilisi, , Georgia
Richmond, Virginia, United States
Hiroshima, Hiroshima, , Japan
San Bernardino, California, United States
Scottsdale, Arizona, United States
Tainan City, , Taiwan
Batumi, , Georgia
Budapest, , Hungary
Austin, Texas, United States
Foshan, , China
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
Orlando, Florida, United States
Xuzhou, , China
Wrocław, , Poland
Wuhan, , China
Tokyo, Bunkyo Ku, , Japan
Lodz, , Poland
Lady Lake, Florida, United States
Springboro, Ohio, United States
Santa Ana, California, 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
Dallas, Texas, United States
Seattle, Washington, United States
Spokane, Washington, United States
Brandon, Florida, United States
Miramar, Florida, United States
Orlando, Florida, United States
Mcallen, Texas, United States
San Antonio, Texas, United States
Ogden, Utah, United States
Chula Vista, California, United States
Gardena, 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
New Port Richey, Florida, United States
Pembroke Pines, Florida, United States
Sarasota, Florida, United States
Meridian, Idaho, United States
Monroe, Louisiana, United States
Minneapolis, Minnesota, United States
Kansas City, Missouri, United States
Reno, Nevada, United States
Hartsdale, New York, United States
Inwood, New York, United States
Westlake, Ohio, United States
Flourtown, Pennsylvania, United States
Columbia, South Carolina, United States
Brownsville, Texas, United States
Edinburg, Texas, United States
Pasadena, Texas, United States
San Antonio, Texas, United States
Wichita Falls, Texas, United States
Seoul, , Korea, Republic Of
Milano, , Italy
Columbia, Missouri, United States
Providence, Rhode Island, United States
Dallas, Texas, United States
Ciudad Autónoma De Buenos Aires, , Argentina
Guangzhou, , China
Guildford, , United Kingdom
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
Chandigarh, , India
Hyderabad, , India
Jaipur, , India
Jaipur, , India
Lucknow, , India
Nagpur, , 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
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
Caba, , Argentina
Ciudad Autonoma De Buenos Aire, , Argentina
Santiago, , Chile
Guangzhou, , China
Guiyang, , China
Ningbo, , China
Suzhou, , China
Zhejiang, , China
Côte D'or, , France
Haute Garonne, , France
Hauts De Seine, , France
Maine Et Loire, , France
Nord Pas De Calais, , France
Paris, , France
Rhône, , France
Rhône, , France
île De France, , France
Tbilisi, , Georgia
Dresden, , Germany
Bekescsaba, , Hungary
Ahemdabad, , India
Roma, , Italy
Shimonoseki, , Japan
Benito Juarez, Mexico, , Mexico
Col. Xoco, , Mexico
Cuautla, , Mexico
Mexico City, , Mexico
Xalapa, , Mexico
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Bucuresti, , Romania
Ramah, , Saudi Arabia
Ankara, , Turkey
Lyon, , France
île De France, , France
Col. Xoco, , Mexico
San Juan, , Puerto Rico
Palermo, , Italy
Chandler, Arizona, 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
San Antonio, Texas, United States
Changzhou Shi, , China
Fuzhou, , China
Yueyang, , China
Bucuresti, , Romania
Berlin, , Germany
Guangzhou, , China
Zhengzhou, , China
Osaka, Suita, , Japan
North Hollywood, California, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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