DelfaGLP-1 Atlas

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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

A Phase III Double-blind, Randomised, Placebo-controlled Trial to Evaluate Liver-related Clinical Outcomes and Safety of Once Weekly Injected Survodutide in Participants With Compensated Non-alcoholic Steatohepatitis/Metabolic Dysfunction Associated Steatohepatitis (NASH/MASH) Cirrhosis

Asset

Survodutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

444

Recruiting sites

337

Enrollment

1,590

estimated

Study population

MASH / NAFLD / liver fibrosis, Obesity / overweight

Key I/E criterion

•BMI ≥27

Primary endpoint

•Hepatic-decompensation composite (All-cause death, Hepatic-decompensation composite, Progression to cirrhosis)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06632457
Org study ID1404-0064
Secondary ID2024-513741-36-00CTIS (EU)
Secondary IDU1111-1307-0227WHO International Clinical Trials Registry Platform (ICTRP)

Timeline

Milestones

Study first posted2024-10-09actual
Study start2024-11-07actual
Last update posted2026-05-28actual
Primary completion2029-06-05estimated
Study completion2029-06-05estimated

Assets

Investigational agents

Survodutide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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 <100,000/µL (<100 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

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

MASH / liver
9
Cardiovascular outcomes
2
Weight & body composition
1
Glycemic / diabetes
1
Cardiometabolic biomarkers
1

Cardiovascular outcomes

2 endpoints
Secondary/protocol endpoint

Occurrence of all-cause hospitalisation (first and recurrent)

Time frame:up to 4.5 years.

All-cause hospitalization

event count, event

Secondary/protocol endpoint

Time to first occurrence of any of the adjudicated components of the composite endpoint 5-point major adverse cardiac event (5P-MACE)

Time frame:up to 4.5 years.

5-point MACE

time to event, event

componentsAll-cause death, Non-fatal MI, Non-fatal stroke, Coronary revascularization, Heart-failure hospitalization

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Key secondary endpoint: Percentage change from baseline in body weight

Time frame:At baseline and at Week 76.

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Key secondary endpoint: Absolute change from baseline in glycosylated haemoglobin A1c (HbA1c) (%) in participants with type 2 diabetes mellitus (T2DM) at baseline

Time frame:At baseline and at Week 76.

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

9 endpoints
Primary/protocol endpoint

Time to first occurrence of any component of the composite clinical endpoint (at EoS) consisting of: all-cause mortality, liver transplant, hepatic decompensation events, worsening of MELD score to ≥15 and progression to CSPH

Time frame:up to 4.5 years.

Hepatic-decompensation composite

time to event, event

componentsAll-cause death, Hepatic-decompensation composite, Progression to cirrhosis

SNOMED 419620001

Secondary/protocol endpoint

Key secondary endpoint: Absolute change from baseline in enhanced liver fibrosis (ELF) score

Time frame:At baseline and at Week 76.

ELF score, change

change from baseline, improvement

Secondary/protocol endpoint

Key secondary endpoint: Absolute change from baseline in liver stiffness (kPa) in FibroScan® vibration-controlled transient elastography (VCTE)

Time frame:At baseline and at Week 76.

Liver stiffness (VCTE), change

change from baseline, improvement

Secondary/protocol endpoint

Percentage change from baseline in liver stiffness in FibroScan® VCTE

Time frame:At baseline and at Week 76.

Liver stiffness (VCTE), change

percent change from baseline, improvement

Secondary/protocol endpoint

Time to first occurrence of progression to CSPH

Time frame:up to 4.5 years.

time to event, event

Secondary/protocol endpoint

Time to first occurrence of any of the hepatic decompensation events (ascites, HE, or portal hypertension-related upper GI bleeding), or worsening of MELD score to ≥15

Time frame:up to 4.5 years.

Hepatic-decompensation composite

time to event, event

componentsHepatic-decompensation composite

Secondary/protocol endpoint

Absolute change from baseline in aspartate aminotransferase (AST) (U/L)

Time frame:At baseline and at Week 76.

AST, change

change from baseline, improvement

LOINC 1920-8

Secondary/protocol endpoint

Absolute change from baseline in alanine aminotransferase (ALT) (U/L)

Time frame:At baseline and at Week 76.

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Absolute change from baseline in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE)

Time frame:At baseline and at Week 76.

Liver stiffness (VCTE), change

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint/low confidence

Absolute changes from baseline in lipids (mg/dL)

Time frame:At baseline and at Week 76.

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.