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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

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 Dysfunction-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 [kg]
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 [kPa] 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 [kg]
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 [kPa] 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, LDL cholesterol, very low-density lipoprotein [VLDL] cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides)
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, LDL cholesterol, very low-density lipoprotein [VLDL] cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides)
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
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
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
* 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

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
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Connecticut
Country [5] 0 0
United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Indiana
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United States of America
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Iowa
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United States of America
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Louisiana
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United States of America
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Michigan
Country [11] 0 0
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Mississippi
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Missouri
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Nebraska
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North Carolina
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Caba
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Florencio Varela
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Pilar
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Graz
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Linz
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Vienna
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Guiyang
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Xi'An
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Xuzhou
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Yueyang
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Zhejiang
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Zhenjiang
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Czechia
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Liberec
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Plzen
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Czechia
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Praha 2
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Lyon
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Paris
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Rhône
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Tbilisi
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Bochum
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Frankfurt
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Heidelberg
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Homburg
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Köln Lindenthal
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Lübeck
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Magdeburg
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Mainz
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Mannheim
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Münster
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Tübingen
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Ulm
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Wiesbaden
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Würzburg
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Hungary
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Bekescsaba
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Hungary
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Budapest
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India
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Ahemdabad
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India
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Chandigarh
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India
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Hyderabad
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India
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Jaipur
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India
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Kanpur
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India
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Lucknow
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India
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Nagpur
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India
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New Delhi
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India
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Rohtak
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Secunderabad
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India
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Surat
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Italy
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Bologna
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Italy
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Foggia
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Italy
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Milano
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Italy
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Modena
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Italy
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Palermo
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Italy
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Roma
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Italy
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Rozzano
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Italy
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Turin
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Japan
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Aichi, Toyoake
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Japan
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Bunkyo-ku
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Japan
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Chiba, Ichikawa
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Japan
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Chiba
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Japan
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Ehime, Toon
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Japan
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Fukui, Fukui
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Japan
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Fukuoka, Fukuoka
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Japan
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Fukuoka, Kurume
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Japan
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Gifu, Gifu
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Japan
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Hanishina-gun
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Japan
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Hiroshima, Hiroshima
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Japan
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Hokkaido, Sapporo
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Japan
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Hyogo, Nishinomiya
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Japan
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Ibaraki, Inashiki-gun
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Japan
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Isehara
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Japan
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Izumo
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Japan
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Kagoshima, Kagoshima
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Japan
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Kanagawa, Kawasaki
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Japan
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Kita-gun
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Japan
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Kobe
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Japan
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Kumamoto, Kumamoto
Country [159] 0 0
Japan
State/province [159] 0 0
Kyoto, Kyoto
Country [160] 0 0
Japan
State/province [160] 0 0
Mie, Tsu
Country [161] 0 0
Japan
State/province [161] 0 0
Miyazaki, Miyazaki
Country [162] 0 0
Japan
State/province [162] 0 0
Nagano, Matsumoto
Country [163] 0 0
Japan
State/province [163] 0 0
Nagasaki, Omura
Country [164] 0 0
Japan
State/province [164] 0 0
Niigata, Niigata
Country [165] 0 0
Japan
State/province [165] 0 0
Osaka, Osaka
Country [166] 0 0
Japan
State/province [166] 0 0
Osaka, Suita
Country [167] 0 0
Japan
State/province [167] 0 0
Saga, Saga
Country [168] 0 0
Japan
State/province [168] 0 0
Sakai
Country [169] 0 0
Japan
State/province [169] 0 0
Sendai-shi
Country [170] 0 0
Japan
State/province [170] 0 0
Shimonoseki
Country [171] 0 0
Japan
State/province [171] 0 0
Shinjuku-ku
Country [172] 0 0
Japan
State/province [172] 0 0
Shizuoka, Hamamatsu
Country [173] 0 0
Japan
State/province [173] 0 0
Shizuoka, Izunokuni
Country [174] 0 0
Japan
State/province [174] 0 0
Takasaki
Country [175] 0 0
Japan
State/province [175] 0 0
Tokyo, Bunkyo-ku
Country [176] 0 0
Japan
State/province [176] 0 0
Tokyo, Minato-ku
Country [177] 0 0
Japan
State/province [177] 0 0
Tokyo, Musashino
Country [178] 0 0
Japan
State/province [178] 0 0
Wakayama
Country [179] 0 0
Japan
State/province [179] 0 0
Yokohama
Country [180] 0 0
Jordan
State/province [180] 0 0
Amman
Country [181] 0 0
Jordan
State/province [181] 0 0
Jordan
Country [182] 0 0
Korea, Republic of
State/province [182] 0 0
Bucheon-Si
Country [183] 0 0
Korea, Republic of
State/province [183] 0 0
Incheon
Country [184] 0 0
Korea, Republic of
State/province [184] 0 0
Seoul
Country [185] 0 0
Mexico
State/province [185] 0 0
Acapulco de Juarez
Country [186] 0 0
Mexico
State/province [186] 0 0
Benito Juarez, Mexico
Country [187] 0 0
Mexico
State/province [187] 0 0
Col. Xoco
Country [188] 0 0
Mexico
State/province [188] 0 0
Cuautla
Country [189] 0 0
Mexico
State/province [189] 0 0
Merida
Country [190] 0 0
Mexico
State/province [190] 0 0
Mexico City
Country [191] 0 0
Mexico
State/province [191] 0 0
Veracruz
Country [192] 0 0
Mexico
State/province [192] 0 0
Xalapa
Country [193] 0 0
Netherlands
State/province [193] 0 0
Amsterdam
Country [194] 0 0
Netherlands
State/province [194] 0 0
Nijmegen
Country [195] 0 0
Netherlands
State/province [195] 0 0
Rotterdam
Country [196] 0 0
Netherlands
State/province [196] 0 0
Tilburg
Country [197] 0 0
Netherlands
State/province [197] 0 0
Uden
Country [198] 0 0
Netherlands
State/province [198] 0 0
Utrecht
Country [199] 0 0
New Zealand
State/province [199] 0 0
Auckland
Country [200] 0 0
Poland
State/province [200] 0 0
Krakow
Country [201] 0 0
Poland
State/province [201] 0 0
Lodz
Country [202] 0 0
Poland
State/province [202] 0 0
Lublin
Country [203] 0 0
Poland
State/province [203] 0 0
Myslowice
Country [204] 0 0
Poland
State/province [204] 0 0
Warsaw
Country [205] 0 0
Poland
State/province [205] 0 0
Warszawa
Country [206] 0 0
Poland
State/province [206] 0 0
Wroclaw
Country [207] 0 0
Poland
State/province [207] 0 0
Lódz
Country [208] 0 0
Puerto Rico
State/province [208] 0 0
San Juan
Country [209] 0 0
Romania
State/province [209] 0 0
Bucuresti
Country [210] 0 0
Romania
State/province [210] 0 0
Cluj-Napoca
Country [211] 0 0
Romania
State/province [211] 0 0
Iasi
Country [212] 0 0
Saudi Arabia
State/province [212] 0 0
Ramah
Country [213] 0 0
Saudi Arabia
State/province [213] 0 0
Riyadh
Country [214] 0 0
Singapore
State/province [214] 0 0
Singapore
Country [215] 0 0
South Africa
State/province [215] 0 0
Johannesburg
Country [216] 0 0
South Africa
State/province [216] 0 0
Plumstead
Country [217] 0 0
Spain
State/province [217] 0 0
A Coruña
Country [218] 0 0
Spain
State/province [218] 0 0
Barcelona
Country [219] 0 0
Spain
State/province [219] 0 0
Córdoba
Country [220] 0 0
Spain
State/province [220] 0 0
Madrid
Country [221] 0 0
Spain
State/province [221] 0 0
Majadahonda
Country [222] 0 0
Spain
State/province [222] 0 0
Pontevedra
Country [223] 0 0
Spain
State/province [223] 0 0
Santiago de Compostela
Country [224] 0 0
Switzerland
State/province [224] 0 0
Bern
Country [225] 0 0
Switzerland
State/province [225] 0 0
Geneve
Country [226] 0 0
Switzerland
State/province [226] 0 0
Lugano
Country [227] 0 0
Switzerland
State/province [227] 0 0
Zuerich
Country [228] 0 0
Taiwan
State/province [228] 0 0
Changhua City
Country [229] 0 0
Taiwan
State/province [229] 0 0
Taichung City
Country [230] 0 0
Taiwan
State/province [230] 0 0
Taichung
Country [231] 0 0
Taiwan
State/province [231] 0 0
Tainan City
Country [232] 0 0
Taiwan
State/province [232] 0 0
Taipei City
Country [233] 0 0
Taiwan
State/province [233] 0 0
Taoyuan City
Country [234] 0 0
Turkey
State/province [234] 0 0
Ankara
Country [235] 0 0
Turkey
State/province [235] 0 0
Bahcelievler
Country [236] 0 0
Turkey
State/province [236] 0 0
Bursa
Country [237] 0 0
Turkey
State/province [237] 0 0
Fatih
Country [238] 0 0
Turkey
State/province [238] 0 0
Istanbul
Country [239] 0 0
Turkey
State/province [239] 0 0
Izmir
Country [240] 0 0
Turkey
State/province [240] 0 0
Rize
Country [241] 0 0
United Kingdom
State/province [241] 0 0
Aberdeen
Country [242] 0 0
United Kingdom
State/province [242] 0 0
Acomb, York
Country [243] 0 0
United Kingdom
State/province [243] 0 0
Birmingham
Country [244] 0 0
United Kingdom
State/province [244] 0 0
Bristol
Country [245] 0 0
United Kingdom
State/province [245] 0 0
Enfield
Country [246] 0 0
United Kingdom
State/province [246] 0 0
Frimley
Country [247] 0 0
United Kingdom
State/province [247] 0 0
Glasgow
Country [248] 0 0
United Kingdom
State/province [248] 0 0
Guildford
Country [249] 0 0
United Kingdom
State/province [249] 0 0
Liverpool
Country [250] 0 0
United Kingdom
State/province [250] 0 0
London
Country [251] 0 0
United Kingdom
State/province [251] 0 0
Northwood
Country [252] 0 0
United Kingdom
State/province [252] 0 0
Nottingham
Country [253] 0 0
United Kingdom
State/province [253] 0 0
Orpington
Country [254] 0 0
United Kingdom
State/province [254] 0 0
Oxford
Country [255] 0 0
United Kingdom
State/province [255] 0 0
Portsmouth
Country [256] 0 0
United Kingdom
State/province [256] 0 0
Preston
Country [257] 0 0
United Kingdom
State/province [257] 0 0
Rochdale
Country [258] 0 0
United Kingdom
State/province [258] 0 0
Sheffield
Country [259] 0 0
United Kingdom
State/province [259] 0 0
Wallasey

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06632444