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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06632444




Registration number
NCT06632444
Ethics application status
Date submitted
8/10/2024
Date registered
9/10/2024
Date last updated
21/02/2025

Titles & IDs
Public title
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
Scientific title
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 Associated Steatohepatitis (NASH/MASH) and (F2) - (F3) Stage of Liver Fibrosis
Secondary ID [1] 0 0
2024-513739-25-00
Secondary ID [2] 0 0
1404-0044
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Dysfunction Associated Steatohepatitis (MASH) 0 0
Liver Fibrosis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Survodutide
Treatment: Drugs - Placebo

Experimental: Survodutide -

Placebo comparator: Placebo -


Treatment: Drugs: Survodutide
Subcutaneous injection

Treatment: Drugs: Placebo
Subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Resolution of MASH without worsening of liver fibrosis on MASH Clinical Research Network (CRN) fibrosis score
Timepoint [1] 0 0
Baseline and at Week 52.
Primary outcome [2] 0 0
Part 1: At least a 1-point improvement in fibrosis stage with no worsening of MASH
Timepoint [2] 0 0
Baseline and at Week 52.
Primary outcome [3] 0 0
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
Timepoint [3] 0 0
Up to 7 years.
Secondary outcome [1] 0 0
Key secondary endpoint part 1: Percentage change from baseline in body weight
Timepoint [1] 0 0
Baseline and at Week 52.
Secondary outcome [2] 0 0
Key secondary endpoint part 1: Absolute change from baseline in glycosylated haemoglobin (HbA1c)
Timepoint [2] 0 0
Baseline and at Week 52.
Secondary outcome [3] 0 0
Key secondary endpoint part 1: Absolute change from baseline in enhanced liver fibrosis (ELF) score
Timepoint [3] 0 0
Baseline and at Week 52.
Secondary outcome [4] 0 0
Key secondary endpoint part 1: Absolute change from baseline in liver stiffness assessed by vibration-controlled transient elastography (VCTE)
Timepoint [4] 0 0
Baseline and at Week 52.
Secondary outcome [5] 0 0
Key secondary endpoint part 1: Achievement of no progression of fibrosis assessed by central pathology (yes/no)
Timepoint [5] 0 0
Baseline and at Week 52.
Secondary outcome [6] 0 0
Key secondary endpoint part 2: Percentage change from baseline in body weight
Timepoint [6] 0 0
At baseline and at Week 114
Secondary outcome [7] 0 0
Key secondary endpoint part 2: Absolute change from baseline in HbA1c
Timepoint [7] 0 0
At baseline and at Week 114
Secondary outcome [8] 0 0
Key secondary endpoint part 2: Absolute change from baseline in ELF score
Timepoint [8] 0 0
At baseline and at Week 114.
Secondary outcome [9] 0 0
Key secondary endpoint part 2: Absolute change from baseline in liver stiffness assessed by VCTE
Timepoint [9] 0 0
At baseline and at Week 114.
Secondary outcome [10] 0 0
Key secondary endpoint part 2: Achievement of no progression of fibrosis assessed by central pathology (yes/no)
Timepoint [10] 0 0
At baseline and at 7 years.
Secondary outcome [11] 0 0
Key secondary endpoint part 2: Occurrence of all-cause hospitalisation (first and recurrent)
Timepoint [11] 0 0
Up to 7 years.
Secondary outcome [12] 0 0
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)
Timepoint [12] 0 0
Up to 7 years.
Secondary outcome [13] 0 0
Part 1: Improvement of liver fat content (LFC)
Timepoint [13] 0 0
At baseline and at Week 52.
Secondary outcome [14] 0 0
Part 2: Improvement of LFC
Timepoint [14] 0 0
At baseline and at Week 114.
Secondary outcome [15] 0 0
Part 1: Absolute change from baseline in LFC in MRI-PDFF
Timepoint [15] 0 0
At baseline and at Week 52.
Secondary outcome [16] 0 0
Part 2: Absolute change from baseline in LFC in MRI-PDFF
Timepoint [16] 0 0
At baseline and at Week 114.
Secondary outcome [17] 0 0
Part 1: Absolute change from baseline in alanine aminotransferase (ALT) [U/L]
Timepoint [17] 0 0
At baseline and at Week 52.
Secondary outcome [18] 0 0
Part 2: Absolute change from baseline in alanine aminotransferase (ALT) [U/L]
Timepoint [18] 0 0
At baseline and at Week 114.
Secondary outcome [19] 0 0
Part 1: Absolute change from baseline in aspartate aminotransferase (AST) [U/L]
Timepoint [19] 0 0
At baseline and at Week 52.
Secondary outcome [20] 0 0
Part 2: Absolute change from baseline in aspartate aminotransferase (AST) [U/L]
Timepoint [20] 0 0
At baseline and at Week 114.
Secondary outcome [21] 0 0
Part 1: Absolute change from baseline in systolic blood pressure (SBP) [mmHg]
Timepoint [21] 0 0
At baseline and at Week 52.
Secondary outcome [22] 0 0
Part 2: Absolute change from baseline in systolic blood pressure (SBP) [mmHg]
Timepoint [22] 0 0
At baseline and at Week 114.
Secondary outcome [23] 0 0
Part 1: Absolute change from baseline in diastolic blood pressure (DBP) [mmHg]
Timepoint [23] 0 0
At baseline and at Week 52.
Secondary outcome [24] 0 0
Part 2: Absolute change from baseline in diastolic blood pressure (DBP) [mmHg]
Timepoint [24] 0 0
At baseline and at Week 114.
Secondary outcome [25] 0 0
Part 1: Absolute changes from baseline in lipids [mg/dL] (including but not limited to: total cholesterol, low-density lipoprotein [LDL] cholesterol, very low density lipoprotein [VLDL], high-density lipoprotein [HDL] cholesterol, triglycerides [TG])
Timepoint [25] 0 0
At baseline and at Week 52.
Secondary outcome [26] 0 0
Part 2: Absolute changes from baseline in lipids [mg/dL] (including but not limited to: total cholesterol, low-density lipoprotein [LDL] cholesterol, very low density lipoprotein [VLDL], high-density lipoprotein [HDL] cholesterol, triglycerides [TG])
Timepoint [26] 0 0
At baseline and at Week 114.
Secondary outcome [27] 0 0
Part 1: Absolute change from baseline in free fatty acids [mg/dL]
Timepoint [27] 0 0
At baseline and at Week 52.
Secondary outcome [28] 0 0
Part 2: Absolute change from baseline in free fatty acids [mg/dL]
Timepoint [28] 0 0
At baseline and at Week 114.
Secondary outcome [29] 0 0
Part 1: Progression to cirrhosis (defined as histological fibrosis score CRN F4) (yes/no)
Timepoint [29] 0 0
At baseline and at Week 52.

Eligibility
Key inclusion 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, with at least 1 point in inflammation and ballooning each) and fibrosis stage F2-F3 proven by a biopsy conducted during the screening period or by a historical biopsy conducted within the last 6 months prior to randomisation
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
5. Further inclusion criteria apply
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 (unless participant is on anticoagulants)
* OR total serum bilirubin concentration =1.5x ULN (participants with a documented history of Gilbert's syndrome can be enrolled if the direct bilirubin is within normal reference range)
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 (including hepatic encephalopathy, variceal bleeding, ascites, and spontaneous bacterial peritonitis)
8. Model for end-stage liver disease (MELD) score =12 due to liver disease.
9. Treatment with any medication for the indication obesity within 3 months before screening biopsy or historical biopsy time point
10. History of either chronic or acute pancreatitis or elevation of serum lipase or amylase >2x ULN as measured by the central laboratory at screening
11. Major surgery (in the opinion of the investigator) performed within 3 months prior to screening or planned during the trial
12. Further exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/12/2031
Actual
Sample size
Target
1800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [6] 0 0
Monash Health - Clayton
Recruitment hospital [7] 0 0
Austin Health - Heidelberg
Recruitment hospital [8] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [9] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment postcode(s) [9] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
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United States of America
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Michigan
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United States of America
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Minnesota
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Mississippi
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Missouri
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Nebraska
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Nevada
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Ciudad Autonoma de Buenos Aire
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Argentina
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Ciudad Autónoma de Buenos Aires
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Argentina
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Florencio Varela
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Argentina
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Pilar
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Argentina
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Ramos Mejía
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Austria
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Graz
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Austria
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Innsbruck
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Linz
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Vienna
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Wels
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Wien
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Belgium
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Anderlecht
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Belgium
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Edegem
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Genk
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Liège
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Roeselare
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Belem
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Cerqueira Cesar
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Porto Alegre
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Sao Jose Do Rio Preto
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Gorna Oryahovitsa
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Bulgaria
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Panagyurishte
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Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Canada
State/province [58] 0 0
Alberta
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Canada
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Ontario
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Canada
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Quebec
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Chile
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La Serena
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Chile
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Santiago
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Chile
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Viña del Mar
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China
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Beijing
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China
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Changchun
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China
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Guangzhou
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China
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Guiyang
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China
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Hangzhou
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China
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Nanchang
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China
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Nanjing
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China
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Ningbo
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China
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Shanghai
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China
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Suzhou
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China
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Tianjin
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China
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Wuhan
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China
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Xi'An
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China
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Xi'an
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China
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Yanji
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China
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Zhejiang
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Czechia
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Brno - Zidenice
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Czechia
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Liberec
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Czechia
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Plzen
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Czechia
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Praha 2
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France
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Côte-d'Or
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France
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Haute-Garonne
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France
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Hauts-de-Seine
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France
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Lyon
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France
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Maine-et-Loire
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France
State/province [89] 0 0
Nord-Pas-de-Calais
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France
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Paris
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France
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Rhône
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France
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Île-de-France
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Georgia
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Batumi
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Georgia
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Tbilisi
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Dresden
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Germany
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Frankfurt
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Germany
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Freiburg
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Germany
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Heidelberg
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Germany
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Homburg
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Germany
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Köln Lindenthal
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Germany
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Lübeck
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Germany
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Magdeburg
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Germany
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Mainz
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Germany
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Mannheim
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Germany
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Münster
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Germany
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Tübingen
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Germany
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Ulm
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Germany
State/province [110] 0 0
Wiesbaden
Country [111] 0 0
Germany
State/province [111] 0 0
Würzburg
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Hungary
State/province [112] 0 0
Bekescsaba
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Hungary
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Budapest
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India
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Ahemdabad
Country [115] 0 0
India
State/province [115] 0 0
Chandigarh
Country [116] 0 0
India
State/province [116] 0 0
Hyderabad
Country [117] 0 0
India
State/province [117] 0 0
Jaipur
Country [118] 0 0
India
State/province [118] 0 0
Kanpur
Country [119] 0 0
India
State/province [119] 0 0
Lucknow
Country [120] 0 0
India
State/province [120] 0 0
Nagpur
Country [121] 0 0
India
State/province [121] 0 0
New Delhi
Country [122] 0 0
India
State/province [122] 0 0
Rohtak
Country [123] 0 0
India
State/province [123] 0 0
Secunderabad
Country [124] 0 0
India
State/province [124] 0 0
Surat
Country [125] 0 0
Italy
State/province [125] 0 0
Foggia
Country [126] 0 0
Italy
State/province [126] 0 0
Milano
Country [127] 0 0
Italy
State/province [127] 0 0
Modena
Country [128] 0 0
Italy
State/province [128] 0 0
Napoli
Country [129] 0 0
Italy
State/province [129] 0 0
Padova
Country [130] 0 0
Italy
State/province [130] 0 0
Palermo
Country [131] 0 0
Italy
State/province [131] 0 0
Roma
Country [132] 0 0
Italy
State/province [132] 0 0
Rozzano
Country [133] 0 0
Italy
State/province [133] 0 0
Turin
Country [134] 0 0
Japan
State/province [134] 0 0
Aichi, Toyoake
Country [135] 0 0
Japan
State/province [135] 0 0
Bunkyo-ku
Country [136] 0 0
Japan
State/province [136] 0 0
Chiba, Ichikawa
Country [137] 0 0
Japan
State/province [137] 0 0
Chiba
Country [138] 0 0
Japan
State/province [138] 0 0
Ehime, Toon
Country [139] 0 0
Japan
State/province [139] 0 0
Fukui, Fukui
Country [140] 0 0
Japan
State/province [140] 0 0
Fukuoka, Fukuoka
Country [141] 0 0
Japan
State/province [141] 0 0
Fukuoka, Kurume
Country [142] 0 0
Japan
State/province [142] 0 0
Gifu, Gifu
Country [143] 0 0
Japan
State/province [143] 0 0
Gifu, Ogaki
Country [144] 0 0
Japan
State/province [144] 0 0
Hanishina-gun
Country [145] 0 0
Japan
State/province [145] 0 0
Hiroshima, Hiroshima
Country [146] 0 0
Japan
State/province [146] 0 0
Hokkaido, Sapporo
Country [147] 0 0
Japan
State/province [147] 0 0
Hyogo, Nishinomiya
Country [148] 0 0
Japan
State/province [148] 0 0
Ibaraki, Inashiki-gun
Country [149] 0 0
Japan
State/province [149] 0 0
Isehara
Country [150] 0 0
Japan
State/province [150] 0 0
Ishikawa, Kanazawa
Country [151] 0 0
Japan
State/province [151] 0 0
Izumo
Country [152] 0 0
Japan
State/province [152] 0 0
Kagawa, Takamatsu
Country [153] 0 0
Japan
State/province [153] 0 0
Kagoshima, Kagoshima
Country [154] 0 0
Japan
State/province [154] 0 0
Kanagawa, Kawasaki
Country [155] 0 0
Japan
State/province [155] 0 0
Kanagawa, Sagamihara
Country [156] 0 0
Japan
State/province [156] 0 0
Kita-gun
Country [157] 0 0
Japan
State/province [157] 0 0
Kobe
Country [158] 0 0
Japan
State/province [158] 0 0
Kumamoto, Kumamoto
Country [159] 0 0
Japan
State/province [159] 0 0
Kure
Country [160] 0 0
Japan
State/province [160] 0 0
Kyoto, Kyoto
Country [161] 0 0
Japan
State/province [161] 0 0
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Wallasey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is open to adults who are at least 18 years old 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.
Trial website
https://clinicaltrials.gov/study/NCT06632444
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Boehringer Ingelheim
Address 0 0
Country 0 0
Phone 0 0
1-800-243-0127
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06632444