GLP-1 Peptide Atlas, by Delfa

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

A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase III Trial Evaluating Long-term Efficacy and Safety of Survodutide Weekly Injections in Adult Participants With Noncirrhotic Non-alcoholic Steatohepatitis/Metabolic Dysfunction-associated Steatohepatitis (NASH/MASH) and (F2) - (F3) Stage of Liver Fibrosis

Lead sponsor

Boehringer Ingelheim

Asset

Survodutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

526

Recruiting sites

414

Enrollment

1,800

estimated

Study population

MASH / NAFLD / liver fibrosis, Obesity / overweight

Key I/E criterion

—

Primary endpoints

•MASH resolution, no fibrosis worsening•Fibrosis ≥1-stage improvement, no MASH worsening•Hepatic-decompensation composite (Progression to cirrhosis, All-cause death, Hepatic-decompensation composite)

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 IDNCT06632444

Org study ID1404-0044

Secondary ID2024-513739-25-00CTIS

Secondary IDU1111-1306-9071WHO International Clinical Trials Registry Platform (ICTRP)

Timeline

Milestones

Study start2024-09-17actual

Study first posted2024-10-09actual

Last update posted2026-05-28actual

Primary completion2031-12-27estimated

Study completion2031-12-27estimated

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 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

Endpoints (32)

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

Cardiometabolic biomarkers

Cardiovascular outcomes

Weight & body composition

Glycemic / diabetes

Cardiovascular outcomes

2 endpoints

Secondary/protocol endpoint

Key secondary endpoint part 2: Occurrence of all-cause hospitalisation (first and recurrent)

Time frame:Up to 7 years.

All-cause hospitalization

event count, event

Secondary/protocol endpoint

Key secondary endpoint part 2: Time to first occurrence of any of the adjudicated components of the composite endpoint 5-point major adverse cardiac event (5P-MACE)5-point major adverse cardiac event (5P-MACE)

Time frame:Up to 7 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

2 endpoints

Secondary/protocol endpoint

Key secondary endpoint part 1: Percentage change from baseline in body weight [kg]

Time frame:Baseline and at Week 52.

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Key secondary endpoint part 2: Percentage change from baseline in body weight [kg]

Time frame:At baseline and at Week 114

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Key secondary endpoint part 1: Absolute change from baseline in glycosylated haemoglobin (HbA1c) [%]

Time frame:Baseline and at Week 52.

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Key secondary endpoint part 2: Absolute change from baseline in HbA1c [%]

Time frame:At baseline and at Week 114

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

18 endpoints

Primary/protocol endpoint

Part 1: Resolution of MASH without worsening of liver fibrosis on MASH Clinical Research Network (CRN) fibrosis score

Time frame:Baseline and at Week 52.

MASH resolution, no fibrosis worsening

categorical status, improvement

SNOMED 442685003

Primary/protocol endpoint

Part 1: At least a 1-point improvement in fibrosis stage with no worsening of MASH

Time frame:Baseline and at Week 52.

Fibrosis ≥1-stage improvement, no MASH worsening

categorical status, improvement

Primary/protocol endpoint

Part 2: Time to first occurrence of any of components of the composite endpoint consisting of progression to cirrhosis, all-cause mortality, liver transplant, hepatic decompensation event(s), worsening of MELD score to ≥15, progression to CSPH

Time frame:Up to 7 years.

Hepatic-decompensation composite

time to event, event

componentsProgression to cirrhosis, All-cause death, Hepatic-decompensation composite

Secondary/protocol endpoint

Key secondary endpoint part 1: Absolute change from baseline in enhanced liver fibrosis (ELF) score

Time frame:Baseline and at Week 52.

ELF score, change

change from baseline, improvement

Secondary/protocol endpoint

Key secondary endpoint part 1: Absolute change from baseline in liver stiffness [kPa] assessed by vibration-controlled transient elastography (VCTE)

Time frame:Baseline and at Week 52.

Liver stiffness (VCTE), change

change from baseline, improvement

Secondary/protocol endpoint

Key secondary endpoint part 1: Achievement of no progression of fibrosis assessed by central pathology (yes/no)

Time frame:Baseline and at Week 52.

Fibrosis, no progression

categorical status, improvement

Secondary/protocol endpoint

Key secondary endpoint part 2: Absolute change from baseline in ELF score

Time frame:At baseline and at Week 114.

ELF score, change

change from baseline, improvement

Secondary/protocol endpoint

Key secondary endpoint part 2: Absolute change from baseline in liver stiffness [kPa] assessed by VCTE

Time frame:At baseline and at Week 114.

Liver stiffness (VCTE), change

change from baseline, improvement

Secondary/protocol endpoint

Key secondary endpoint part 2: Achievement of no progression of fibrosis assessed by central pathology (yes/no)

Time frame:At baseline and at 7 years.

Fibrosis, no progression

categorical status, improvement

Secondary/protocol endpoint

Part 1: Improvement of liver fat content (LFC)

Time frame:At baseline and at Week 52.

MRI-PDFF ≥30% responders

threshold achievement, improvement

Secondary/protocol endpoint

Part 2: Improvement of LFC

Time frame:At baseline and at Week 114.

MRI-PDFF ≥30% responders

threshold achievement, improvement

Secondary/protocol endpoint

Part 1: Absolute change from baseline in LFC [%] in MRI-PDFF

Time frame:At baseline and at Week 52.

Liver fat content, change

change from baseline, improvement

Secondary/protocol endpoint

Part 2: Absolute change from baseline in LFC [%] in MRI-PDFF

Time frame:At baseline and at Week 114.

Liver fat content, change

change from baseline, improvement

Secondary/protocol endpoint

Part 1: Absolute change from baseline in alanine aminotransferase (ALT) [U/L]

Time frame:At baseline and at Week 52.

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Part 2: Absolute change from baseline in alanine aminotransferase (ALT) [U/L]

Time frame:At baseline and at Week 114.

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Part 1: Absolute change from baseline in aspartate aminotransferase (AST) [U/L]

Time frame:At baseline and at Week 52.

AST, change

change from baseline, improvement

LOINC 1920-8

Secondary/protocol endpoint

Part 2: Absolute change from baseline in aspartate aminotransferase (AST) [U/L]

Time frame:At baseline and at Week 114.

AST, change

change from baseline, improvement

LOINC 1920-8

Secondary/protocol endpoint

Part 1: Progression to cirrhosis (defined as histological fibrosis score CRN F4) (yes/no)

Time frame:At baseline and at Week 52.

Progression to cirrhosis

categorical status, improvement

Cardiometabolic biomarkers

8 endpoints

Secondary/protocol endpoint

Part 1: Absolute change from baseline in systolic blood pressure (SBP) [mmHg]

Time frame:At baseline and at Week 52.

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Part 2: Absolute change from baseline in systolic blood pressure (SBP) [mmHg]

Time frame:At baseline and at Week 114.

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Part 1: Absolute change from baseline in diastolic blood pressure (DBP) [mmHg]

Time frame:At baseline and at Week 52.

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Part 2: Absolute change from baseline in diastolic blood pressure (DBP) [mmHg]

Time frame:At baseline and at Week 114.

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Part 1: Absolute changes from baseline in lipids [mg/dL] (including but not limited to: total cholesterol, LDL cholesterol, very low-density lipoprotein [VLDL] cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides)

Time frame:At baseline and at Week 52.

change from baseline, improvement

Secondary/protocol endpoint

Part 2: Absolute changes from baseline in lipids [mg/dL] (including but not limited to: total cholesterol, LDL cholesterol, very low-density lipoprotein [VLDL] cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides)

Time frame:At baseline and at Week 114.

change from baseline, improvement

Secondary/protocol endpoint

Part 1: Absolute change from baseline in free fatty acids [mg/dL]

Time frame:At baseline and at Week 52.

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint

Part 2: Absolute change from baseline in free fatty acids [mg/dL]

Time frame:At baseline and at Week 114.

Free fatty acids, change

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.