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RecruitingPhase 3

LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis

Boehringer Ingelheim · NCT06632444

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

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
1800
US sites recruiting
155
Study start
October 14, 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 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.

Being studied: Survodutide; Placebo

Conditions: Metabolic Dysfunction Associated Steatohepatitis (MASH); Liver Fibrosis

Eligibility criteria

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

Show full criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Any history or evidence of acute or chronic liver disease other than MASH
  • Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy
  • History of or current diagnosis of hepatocellular carcinoma
  • History of or planned liver transplant
  • Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct.
  • 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

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

  • Fresno Clinical Research Center

    Fresno, CA 93720

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

  • Velocity Clinical Research-Gardena-69773

    Gardena, CA 90247

    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

  • ARK Clinical Research

    Long Beach, CA 90815

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

  • Velocity Clinical Research, Westlake

    Los Angeles, CA 90057

    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

  • California Liver Research Institute

    Pasadena, CA 91105

    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

  • Velocity Clinical Research, Van Nuys

    Van Nuys, CA 91405

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

  • Om Research, LLC

    Victorville, CA 92395

    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

  • Yale University School of Medicine

    New Haven, CT 06520

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

  • OMEGA Research Group

    Altamonte Springs, FL 32714

    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

  • Tampa Bay Medical Research

    Clearwater, FL 33761

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

  • K2 Medical Research - Winter Garden

    Clermont, FL 34711

    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

  • Florida Research Institute

    Lakewood Rch, FL 34211

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

  • K2 Medical Research

    Maitland, FL 32751

    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

  • 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

  • GI Pros Research

    Naples, FL 34102

    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

  • 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

  • Progressive Medical Research

    Port Orange, FL 32127

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

+ 95 more on the official record.

Study contacts (from the official record)

  • Boehringer Ingelheim · 1-800-243-0127 · clintriage.rdg@boehringer-ingelheim.com
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LIVERAGE™: A Study to Test Whether Survodutide Helps People With a… (NCT06632444) | Bored Studies