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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

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
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
Timepoint [1] 0 0
Baseline and 28 weeks
Primary outcome [2] 0 0
Percentage of Participants Who Experienced an Adverse Event (AE)
Timepoint [2] 0 0
Up to approximately 36 weeks
Primary outcome [3] 0 0
Percentage of Participants Discontinuing Study Medication Due to an AE
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
Timepoint [1] 0 0
Baseline and up to 28 Weeks
Secondary outcome [2] 0 0
Change from Baseline in Enhanced Liver Fibrosis (ELF)
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
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
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
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
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
15/05/2026
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
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Nevada
Country [8] 0 0
United States of America
State/province [8] 0 0
New Mexico
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
France
State/province [11] 0 0
Aquitaine
Country [12] 0 0
France
State/province [12] 0 0
Rhone-Alpes
Country [13] 0 0
Israel
State/province [13] 0 0
Haifa
Country [14] 0 0
Israel
State/province [14] 0 0
Jerusalem
Country [15] 0 0
Japan
State/province [15] 0 0
Kanagawa
Country [16] 0 0
Japan
State/province [16] 0 0
Kyoto
Country [17] 0 0
Japan
State/province [17] 0 0
Osaka
Country [18] 0 0
Japan
State/province [18] 0 0
Saga
Country [19] 0 0
Puerto Rico
State/province [19] 0 0
Guaynabo
Country [20] 0 0
Puerto Rico
State/province [20] 0 0
San Juan
Country [21] 0 0
Spain
State/province [21] 0 0
Cantabria
Country [22] 0 0
Spain
State/province [22] 0 0
Castilla Y Leon
Country [23] 0 0
Spain
State/province [23] 0 0
Barcelona
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid
Country [25] 0 0
Thailand
State/province [25] 0 0
Krung Thep Maha Nakhon
Country [26] 0 0
United Kingdom
State/province [26] 0 0
London, City Of

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 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
Fax 0 0
Email 0 0
Trialsites@msd.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


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