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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06465186




Registration number
NCT06465186
Ethics application status
Date submitted
13/06/2024
Date registered
18/06/2024
Date last updated
4/07/2025

Titles & IDs
Public title
A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017)
Scientific title
Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults With Compensated Cirrhosis Secondary to Metabolic Dysfunction-Associated Steatohepatitis
Secondary ID [1] 0 0
2024-510923-20-00
Secondary ID [2] 0 0
6024-017
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-alcoholic Fatty Liver Disease 0 0
Nonalcoholic Steatohepatitis 0 0
NAFLD 0 0
Metabolic Dysfunction-associated Steatotic Liver Disease 0 0
Metabolic Dysfunction-associated Steatohepatitis 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
Cancer 0 0 0 0
Liver
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Efinopegdutide
Other interventions - Placebo

Experimental: Efinopegdutide - Participants will start efinopegdutide once a week at the lowest dose level. Then, the dose level will go up every month for three months until they are getting the highest dose level. Efinopegdutide is given as an injection under the skin (subcutaneous injection) for 28 weeks.

Placebo comparator: Placebo - Participants will receive placebo once a week. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of a study medicine.

Placebo is given as an injection under the skin (subcutaneous injection) for 28 weeks.


Other interventions: Efinopegdutide
Efinopegdutide is given as a subcutaneous injection using a single-use prefilled syringe, once per week for 28 weeks

Other interventions: Placebo
Placebo is given as a subcutaneous injection using a single-use prefilled syringe once per week for 28 weeks.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in Liver Fat Content (LFC) at Week 28
Assessment method [1] 0 0
Researchers will measure the change in the amount of fat in the liver using magnetic resonance imaging (MRI) after about 7 months of treatment. The change in MRI-Estimated proton density fat fraction (PDFF) will be measured from baseline to 28 weeks.
Timepoint [1] 0 0
Baseline and 28 weeks
Primary outcome [2] 0 0
Percentage of Participants Who Experienced an Adverse Event (AE)
Assessment method [2] 0 0
An AE is a health problem that happens or worsens during the study
Timepoint [2] 0 0
Up to approximately 36 weeks
Primary outcome [3] 0 0
Percentage of Participants Discontinuing Study Medication Due to an AE
Assessment method [3] 0 0
An AE is a health problem that happens or worsens during a study. The percentage of participants who stop study treatment due to an AE will be reported.
Timepoint [3] 0 0
Up to approximately 28 weeks
Secondary outcome [1] 0 0
Change from Baseline in Iron-corrected T1 (cT1) at Week 28
Assessment method [1] 0 0
Researchers will measure the change in liver inflammation and scarring (fibrosis) after about 7 months of treatment. MRI measurement of cT1 mapping will be used to indicate the amount of liver inflammation and fibrosis. The change in cT1 mapping from baseline to 28 weeks will be presented.
Timepoint [1] 0 0
Baseline and up to 28 Weeks
Secondary outcome [2] 0 0
Change from Baseline in Enhanced Liver Fibrosis (ELF) score at Week 28
Assessment method [2] 0 0
Researchers will measure the change in liver scarring using biomarkers. Biomarkers are substances measured in blood that show normal or abnormal activity taking place in the liver. ELF is calculated using 3 markers of hepatic extracellular matrix turnover to generate a unitless numerical score. The change from baseline in ELF up to 28 weeks will be reported.
Timepoint [2] 0 0
Baseline and up to 28 weeks
Secondary outcome [3] 0 0
Change from Baseline in Propeptide of Type III Collagen (Pro-C3) at Week 28
Assessment method [3] 0 0
Researchers will measure the change in liver scarring using biomarkers. Pro-C3 is measured in serum; Increasing levels indicate worsening of fibrosis activity. The change in Pro-C3 from baseline to 28 weeks will be reported.
Timepoint [3] 0 0
Baseline and up to 28 weeks
Secondary outcome [4] 0 0
Change from Baseline in Fibrosis-4 index (FIB-4) at Week 28
Assessment method [4] 0 0
Researchers will measure the change in liver scarring using biomarkers. FIB-4 index is calculated using the participant's age and 3 serum markers (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], and platelet count). The change from baseline in FIB-4 after 28 weeks will be reported.
Timepoint [4] 0 0
Baseline and up to 28 weeks
Secondary outcome [5] 0 0
Change from Baseline in Liver Stiffness Measurement (LSM) Assessed by Vibration-controlled Transient Elastography (VCTE) at week 28
Assessment method [5] 0 0
Researchers will measure the change in liver scarring using ultrasound. LSM is measured using VCTE. The change from baseline in LSM after 28 weeks will be reported.
Timepoint [5] 0 0
Baseline and up to 28 weeks
Secondary outcome [6] 0 0
Percent Change from Baseline in Body Weight at Week 28
Assessment method [6] 0 0
Body weight will be measured using a standardized, digital scale. The percent change from baseline in body weight after 28 weeks will be reported
Timepoint [6] 0 0
Baseline and up to approximately 28 weeks

Eligibility
Key inclusion criteria
The main inclusion criteria include but are not limited to the following:

* Has compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH)
* Has either type 2 diabetes that is controlled by diet or medication, or does not have type 2 diabetes
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The main exclusion criteria include but are not limited to the following:

* Has history of a liver disease other than MASH, for example, Hepatitis B or C, drug-induced liver disease, or autoimmune liver disease
* Has history of type 1 diabetes
* Had a bariatric surgical procedure less than 5 years before entry into the study
* History of pancreatitis
* Major illnesses like recent (within 6 months of study entry) episodes of heart problems, such as congestive heart failure, unstable angina, heart attack, stroke, or mini-stroke

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 2
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
12/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/09/2026
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 1202) - Adelaide
Recruitment hospital [2] 0 0
St Vincent's Hospital-Gastroenterology Department ( Site 1205) - Melbourne
Recruitment postcode(s) [1] 0 0
5042 - Adelaide
Recruitment postcode(s) [2] 0 0
3065 - Melbourne
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
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New Mexico
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
Colombia
State/province [15] 0 0
Cundinamarca
Country [16] 0 0
Colombia
State/province [16] 0 0
Valle Del Cauca
Country [17] 0 0
France
State/province [17] 0 0
Aquitaine
Country [18] 0 0
France
State/province [18] 0 0
Hauts-de-Seine
Country [19] 0 0
France
State/province [19] 0 0
Limousin
Country [20] 0 0
France
State/province [20] 0 0
Rhone-Alpes
Country [21] 0 0
Israel
State/province [21] 0 0
Haifa
Country [22] 0 0
Israel
State/province [22] 0 0
Jerusalem
Country [23] 0 0
Israel
State/province [23] 0 0
Petah Tikva
Country [24] 0 0
Japan
State/province [24] 0 0
Kanagawa
Country [25] 0 0
Japan
State/province [25] 0 0
Kyoto
Country [26] 0 0
Japan
State/province [26] 0 0
Osaka
Country [27] 0 0
Japan
State/province [27] 0 0
Saga
Country [28] 0 0
Puerto Rico
State/province [28] 0 0
Guaynabo
Country [29] 0 0
Puerto Rico
State/province [29] 0 0
San Juan
Country [30] 0 0
Spain
State/province [30] 0 0
Cantabria
Country [31] 0 0
Spain
State/province [31] 0 0
Castilla Y Leon
Country [32] 0 0
Spain
State/province [32] 0 0
Ciudad Real
Country [33] 0 0
Spain
State/province [33] 0 0
La Coruna
Country [34] 0 0
Spain
State/province [34] 0 0
Barcelona
Country [35] 0 0
Spain
State/province [35] 0 0
Madrid
Country [36] 0 0
Spain
State/province [36] 0 0
Sevilla
Country [37] 0 0
Thailand
State/province [37] 0 0
Krung Thep Maha Nakhon
Country [38] 0 0
United Kingdom
State/province [38] 0 0
London, City Of
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Scotland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Email 0 0
Trialsites@msd.com
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/NCT06465186