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RecruitingPhase 3

LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis

Boehringer Ingelheim · NCT06632457

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
1590
US sites recruiting
124
Study start
November 12, 2024
Record last updated
October 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

This study is open to adults who are at least 18 years old and have:

  • A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or
  • A confirmed liver disease called metabolic-associated steatohepatitis (MASH)
  • BMI of 27 kg/m2 or more or
  • 25 kg/m2 or more if the participant is Asian.

People with a history of other chronic liver diseases or high 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 NASH or MASH improve their 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. All participants regularly receive counselling to make changes to their diet and to exercise regularly.

Participants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have 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 is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.

Being studied: Survodutide; Placebo matching survodutide

Conditions: Metabolic Dysfunction Associated Steatohepatitis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion criteria

  • 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
  • Body mass index (BMI) ≥27 kg/m2(≥25 kg/m2 for Asian trial participants)
  • Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis.
  • 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.
  • Further inclusion criteria apply.

Exclusion criteria

  • 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.
  • Model of end-stage liver Disease (MELD) score >12 due to liver disease
  • 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
  • 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 \<100,000/µL (\<100 GI/L)
  • 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
  • Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg)) or history of chronic HBV infection
  • Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA))
  • Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >5x ULN
  • Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history
  • History of liver transplantation or listed for liver transplantation
  • History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological/surgical procedure for portal hypertension treatment
  • Further exclusion criteria apply

Recruiting US locations

  • The Institute for Liver Health II DBA Arizona Clinical Trials

    Peoria, AZ 85381

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Scottsdale Medical Specialists, Ltd

    Scottsdale, AZ 85258

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Adobe Clinical Research, LLC

    Tucson, AZ 85712

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Arizona Liver Health - Tucson

    Tucson, AZ 85712

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Del Sol Research Management, LLC

    Tucson, AZ 85715

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Hope Clinical Research

    Canoga Park, CA 91303

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Velocity Clinical Research-Chula Vista

    Chula Vista, CA 91911

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Southern California Research Center

    Coronado, CA 92118

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • ARK Clinical Research

    Fountain Valley, CA 92708

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Velocity Clinical Research-Huntington Park

    Huntington Park, CA 90255

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • 310 Clinical Research

    Inglewood, CA 90301

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Velocity Clinical Research, San Diego

    La Mesa, CA 91942

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Om Research, LLC

    Lancaster, CA 93534

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Catalina Research Institute, LLC

    Montclair, CA 91763

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Clinnova Research Solutions

    Orange, CA 92868

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Fomat Medical Research

    Oxnard, CA 93030

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Cadena Care Institute, LLC

    Poway, CA 92064

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Ficramed Research Institute

    Poway, CA 92064

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Inland Empire Clinical Trials, LLC

    Rialto, CA 92377

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Metro Clinical Trials

    San Bernardino, CA 92404

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Acclaim Clinical Research

    San Diego, CA 92120

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Future Innovative Treatments

    Colorado Springs, CO 80907

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • South Denver Gastroenterology PC

    Englewood, CO 80113

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Connecticut Gastroenterology Clinical Research Foundation

    Bristol, CT 06010

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Synergy Healthcare

    Bradenton, FL 34209

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Synergy Healthcare of Tampa

    Brandon, FL 33511

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Access research Institute

    Brooksville, FL 34613

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Hi Tech and Global Research, LLC

    Coral Gables, FL 33134

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Cenara Clinical Research

    Cutler Bay, FL 33189

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Covenant Metabolic Specialists, LLC - Fort Myers

    Fort Myers, FL 33912

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Neoclinical Research

    Hialeah, FL 33016

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Evolution Clinical Trials

    Hialeah Gardens, FL 33016

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Global Research Associates

    Homestead, FL 33030

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Lake Center for Clinical Research

    Lady Lake, FL 32159

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Research Associates of South Florida, LLC

    Miami, FL 33134

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Optimus U Corporation-Miami-69452

    Miami, FL 33135

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Schiff Center Liver Diseases

    Miami, FL 33136

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • BioMed Research & Medical Center

    Miami, FL 33156

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • MplusM - Century Research

    Miami, FL 33173

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • ECIR Miami Holdings LLC dba IMIC

    Miami, FL 33176

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Entrust Clinical Research

    Miami, FL 33176

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Floridian Clinical Research

    Miami Lakes, FL 33016

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Advanced Research Institute

    New Port Richey, FL 34653

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Charter Research

    Orlando, FL 32803

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • OMEGA Research Group

    Orlando, FL 32808

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Endoscopic Research, Inc

    Orlando, FL 32828

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Innovation Medical Research Center

    Palmetto Bay, FL 33157

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • MplusM - Best Choice Medical and Research Service

    Pembroke Pines, FL 33024

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Covenant Metabolic Specialist, LLC - Riverview

    Riverview, FL 33578

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Global Clinical Professionals

    St. Petersburg, FL 33714

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • International Center for Research

    Tampa, FL 33618

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Charter Research

    The Villages, FL 32162

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Covenant Metabolic Specialists, LLC - University Park

    University Park, FL 34201

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Conquest Research

    Winter Park, FL 32789

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Florida Medical Clinic, P.A.

    Zephyrhills, FL 33542

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Piedmont Hospital

    Atlanta, GA 30309

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Gastroenterology Associates of Central Georgia

    Macon, GA 31201

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • EmVenio Research Center at Prime Healthcare - Riverdale

    Riverdale, GA 30274

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • ASHA Clinical Research - Munster, LLC

    Hammond, IN 46324

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Digestive Research Alliance of Michiana

    South Bend, IN 46635

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

+ 64 more on the official record.

Study contacts (from the official record)

  • Boehringer Ingelheim · 1-800-243-0127 · clintriage.rdg@boehringer-ingelheim.com
All nutrition & metabolism studies in Arizona →
LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps… (NCT06632457) | Bored Studies