Clinical trial NCT06465186: A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017)
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-alcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis
NAFLD
Metabolic Dysfunction-associated Steatotic Liver Disease
Metabolic Dysfunction-associated Steatohepatitis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-06-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Researchers are looking for ways to treat a type of liver disease caused by elevated liver fat, called metabolic dysfunction-associated steatohepatitis (MASH). MASH was formerly called non-alcoholic steatohepatitis (NASH). Researchers want to learn if a study medicine called efinopegdutide can treat MASH.The goals of this study are to learn:

* If efinopegdutide can lower the amount of fat, inflammation, and scarring (fibrosis) in the liver
* About the safety of efinopegdutide and how well people tolerate it


Eligibility criteria: 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

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

Primary outcomes:
measure: Change from Baseline in Liver Fat Content (LFC) at Week 28
timeFrame: Baseline and 28 weeks
measure: Percentage of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to approximately 36 weeks
measure: Percentage of Participants Discontinuing Study Medication Due to an AE
timeFrame: Up to approximately 28 weeks
Secondary outcomes:
measure: Change from Baseline in Iron-corrected T1 (cT1) at Week 28
timeFrame: Baseline and up to 28 Weeks
measure: Change from Baseline in Enhanced Liver Fibrosis (ELF) score at Week 28
timeFrame: Baseline and up to 28 weeks
measure: Change from Baseline in Propeptide of Type III Collagen (Pro-C3) at Week 28
timeFrame: Baseline and up to 28 weeks
measure: Change from Baseline in Fibrosis-4 index (FIB-4) at Week 28
timeFrame: Baseline and up to 28 weeks
measure: Change from Baseline in Liver Stiffness Measurement (LSM) Assessed by Vibration-controlled Transient Elastography (VCTE) at week 28
timeFrame: Baseline and up to 28 weeks
measure: Percent Change from Baseline in Body Weight at Week 28
timeFrame: Baseline and up to approximately 28 weeks
Other outcomes:
Locations:
city: Chandler
country: United States
facility: The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0149)
state: Arizona
city: Flagstaff
country: United States
facility: Arizona Clinical Trials ( Site 0158)
state: Arizona
city: Peoria
country: United States
facility: The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0120)
state: Arizona
city: Tucson
country: United States
facility: The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 0111)
state: Arizona
city: Pasadena
country: United States
facility: California Liver Research Institute ( Site 0113)
state: California
city: San Diego
country: United States
facility: Acclaim Clinical Research ( Site 0137)
state: California
city: Van Nuys
country: United States
facility: Velocity Clinical Research, Panorama City ( Site 0124)
state: California
city: Littleton
country: United States
facility: Rocky Mountain Gastroenterology ( Site 0127)
state: Colorado
city: Bradenton
country: United States
facility: Synergy Healthcare ( Site 0118)
state: Florida
city: Homestead
country: United States
facility: Homestead Associates in Research, Inc. ( Site 0139)
state: Florida
city: Lakewood Ranch
country: United States
facility: Florida Research Institute ( Site 0116)
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Clinical Research, LLC ( Site 0109)
state: Florida
city: Dalton
country: United States
facility: Southeast Clinical Research Center ( Site 0119)
state: Georgia
city: Bastrop
country: United States
facility: Delta Research Partners ( Site 0160)
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center ( Site 0161)
state: Louisiana
city: Glen Burnie
country: United States
facility: Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 0130)
state: Maryland
city: Rockville
country: United States
facility: Velocity Clinical Research Rockville ( Site 0143)
state: Maryland
city: Ypsilanti
country: United States
facility: Huron Gastroenterology ( Site 0102)
state: Michigan
city: Las Vegas
country: United States
facility: The Machuca Foundation ( Site 0115)
state: Nevada
city: Las Vegas
country: United States
facility: Excel Clinical Research, LLC ( Site 0101)
state: Nevada
city: Albuquerque
country: United States
facility: Southwest Gastroenterology Associates ( Site 0129)
state: New Mexico
city: Fayetteville
country: United States
facility: Coastal Research Institute - Fayetteville ( Site 0159)
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research, Inc ( Site 0105)
state: North Carolina
city: Arlington
country: United States
facility: Texas Clinical Research Institute ( Site 0126)
state: Texas
city: Austin
country: United States
facility: Pinnacle Clinical Research ( Site 0104)
state: Texas
city: Corpus Christi
country: United States
facility: Pinnacle Clinical Research-Corpus Christi ( Site 0156)
state: Texas
city: Dallas
country: United States
facility: Zenos Clinical Research ( Site 0136)
state: Texas
city: Fort Worth
country: United States
facility: GI Alliance Department of Research ( Site 0162)
state: Texas
city: Houston
country: United States
facility: Houston Research Institute ( Site 0117)
state: Texas
city: San Antonio
country: United States
facility: American Research Corporation ( Site 0131)
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research-Clinical Research Coordination ( Site 0125)
state: Texas
city: Adelaide
country: Australia
facility: Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 1202)
state: South Australia
city: Melbourne
country: Australia
facility: St Vincent's Hospital-Gastroenterology Department ( Site 1205)
state: Victoria
city: Toronto
country: Canada
facility: Toronto General Hospital ( Site 0207)
state: Ontario
city: Quebec
country: Canada
facility: Diex Recherche Quebec ( Site 0204)
city: Bogotá
country: Colombia
facility: Fundacion Santa Fe de Bogota ( Site 0403)
state: Cundinamarca
city: Cali
country: Colombia
facility: Fundación Valle del Lili ( Site 0402)
state: Valle Del Cauca
city: Pessac
country: France
facility: CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0701)
state: Aquitaine
city: Limoges
country: France
facility: Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-Hépato-gastroentérologie ( Site 0702)
state: Limousin
city: Lyon
country: France
facility: Hôpital de la Croix Rousse-Centre de Recherche Clinique ( Site 0705)
state: Rhone-Alpes
city: Haifa
country: Israel
facility: Rambam Health Care Campus ( Site 0801)
city: Haifa
country: Israel
facility: Carmel Hospital-Liver Unit ( Site 0802)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center ( Site 0805)
city: Petah Tikva
country: Israel
facility: Maccabi Health Services - Petah Tikva ( Site 0804)
city: Kawasaki
country: Japan
facility: Shinyurigaoka General Hospital ( Site 1401)
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Hospital ( Site 1402)
state: Kanagawa
city: Kyoto
country: Japan
facility: University Hospital,Kyoto Prefectural University of Medicine ( Site 1404)
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital ( Site 1403)
city: Saga
country: Japan
facility: Saga University Hospital ( Site 1405)
city: Guaynabo
country: Puerto Rico
facility: ISIS CLINICAL RESEARCH CENTER ( Site 0606)
city: San Juan
country: Puerto Rico
facility: Klinical Investigations Group-Clinical Research ( Site 0601)
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 1004)
state: Cantabria
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid-Servicio de Endocrinologia y Nutricion ( Site 1008)
state: Castilla Y Leon
city: Tomelloso
country: Spain
facility: Hospital General de Tomelloso-Aparato Digestivo ( Site 1006)
state: Ciudad Real
city: A Coruña
country: Spain
facility: CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 1007)
state: La Coruna
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 1002)
city: Madrid
country: Spain
facility: Hospital Universitario La Paz-HEPATOLOGIA ( Site 1005)
city: Sevilla
country: Spain
facility: HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos clinicos de Aparato Digestivo ( Site 1001)
city: Bangkok
country: Thailand
facility: Chulalongkorn University ( Site 1301)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital-Department of Medicine ( Site 1302)
state: Krung Thep Maha Nakhon
city: London
country: United Kingdom
facility: King's College Hospital ( Site 1104)
state: London, City Of
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 1102)
state: Scotland
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: