Clinical trial • Phase II • Endocrinology

EFINOPEGDUTIDE for Metabolic dysfunction-associated steatohepatitis (MASH) | Compensated cirrhosis

Phase II trial of EFINOPEGDUTIDE for Metabolic dysfunction-associated steatohepatitis (MASH) | Compensated cirrhosis.

Overview

Trial Therapeutic Area
Endocrinology
Trial Disease
Metabolic dysfunction-associated steatohepatitis (MASH) | Compensated cirrhosis
Trial Stage
Phase II
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
16-04-2024
First CTIS Authorization Date
05-08-2024

Trial design

Randomised, placebo to mk-6024 (matching placebo). active comparator arms: efinopegdutide (mk-6024) — dose and schedule not specified in available documents.-controlled Phase II trial across 14 sites in Spain, France.

Randomised
Yes
Comparator
Placebo to MK-6024 (matching placebo). Active comparator arms: efinopegdutide (MK-6024) — dose and schedule not specified in available documents.
Target Sample Size
65
Trial Duration For Participant
196

Eligibility

Recruits 65 No vulnerable populations selected (isVulnerablePopulationSelected: false). The trial enrols adults; informed consent is required from participants. Subject information and informed consent forms are provided (L1_ICF_Main consent documents for Spain and France; optional associated person and pregnancy follow-up consent documents are also listed)..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). The trial enrols adults; informed consent is required from participants. Subject information and informed consent forms are provided (L1_ICF_Main consent documents for Spain and France; optional associated person and pregnancy follow-up consent documents are also listed).

Inclusion criteria

  • {"criterion_text":"- Has compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH)"}
  • {"criterion_text":"- Has either type 2 diabetes mellitus (T2DM) that is controlled by diet or medication, or does not have type 2 diabetes mellitus"}

Exclusion criteria

  • {"criterion_text":"- Has a history of liver disease other than MASH, for example, Hepatitis B or C, drug-induced liver disease, or autoimmune liver disease"}
  • {"criterion_text":"- Has history of type 1 diabetes mellitus (T1DM)"}
  • {"criterion_text":"- Had bariatric surgical procedure less than 5 years before entry into the study"}
  • {"criterion_text":"- History of pancreatitis"}
  • {"criterion_text":"- 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"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from baseline in liver fat content (LFC) at week 28","definition_or_measurement_approach":"Change from baseline in liver fat content (LFC) measured at week 28 (relative reduction from baseline after 28 weeks)."}
  • {"endpoint_text":"- Percentage of participants who experienced an adverse event (AE)","definition_or_measurement_approach":"Proportion (percentage) of participants reporting any adverse event (AE) during the study (safety reporting)."}
  • {"endpoint_text":"- Percentage of participants discontinuing study medication due to an AE","definition_or_measurement_approach":"Proportion (percentage) of participants who discontinue study medication because of an adverse event."}

Secondary endpoints

  • {"endpoint_text":"- Change from baseline in iron-corrected T1 (cT1) at week 28","definition_or_measurement_approach":"Change from baseline in iron-corrected T1 (cT1) measured at week 28."}
  • {"endpoint_text":"- Change from baseline in enhanced liver fibrosis (ELF) score at week 28","definition_or_measurement_approach":"Change from baseline in ELF score measured at week 28."}
  • {"endpoint_text":"- Change from baseline in propeptide of type III collagen (Pro-C3) at week 28","definition_or_measurement_approach":"Change from baseline in Pro-C3 measured at week 28."}
  • {"endpoint_text":"- Change from baseline in fibrosis-4 index (FIB-4) at week 28","definition_or_measurement_approach":"Change from baseline in FIB-4 index measured at week 28."}
  • {"endpoint_text":"- Change from baseline in liver stiffness measurement (LSM) assessed by vibration-controlled transient elastography (VCTE) at week 28","definition_or_measurement_approach":"Change from baseline in LSM assessed by vibration-controlled transient elastography (VCTE) measured at week 28."}
  • {"endpoint_text":"- Percent change from baseline in body weight at week 28","definition_or_measurement_approach":"Percent change from baseline in body weight measured at week 28."}

Recruitment

Digital Remote Recruitment
True, recruitment materials include website-based recruitment and call centre (Parexel EUB Services).
Planned Sample Size
65
Recruitment Window Months
26
Consent Approach
Informed consent is required from adult participants. Subject information and informed consent forms are provided for Spain and France (L1_ICF_Main consent documents listed for both countries). Optional consent forms (e.g., associated person, pregnancy follow-up) are available. Documents are available in local languages (Spanish and French) as indicated by document filenames.

Methods

  • Spain: Recruitment arrangements documents indicate use of patient brochure and website (document titles: K1_Recruitment Arrangements_ESP_ES_for pub; K2_Recruitment Doc Patient Brochure_ESP_ES_for pub; K2_Recruitment Doc Website_ESP_ES_SM-5_for pub).
  • France: Recruitment arrangements documents indicate use of patient brochure, website, patient visit procedure guide/calendar and print ad (document titles: K1_Recruitment Arrangements and IC Procedure_FRA_FR_SM07_for pub; K2_Recruitment Doc Patient Brochure_FRA_FR_for pub; K2_Recruitment Doc Website_FRA_FR_SM05_for pub; K2_Recruitment Doc Patient Print Ad_FRA_FR_for pub; K2_Recruitment Doc Patient Visit Procedure Guide with Calendar_FRA_FR_for pub).
  • Call centre / EUB services: Parexel listed sponsor duties include 'EUB Services (call center and medical services)', indicating phone-based subject support/contact for recruitment or study queries.

Geography

Total Number Of Sites
14
Total Number Of Participants
24

Spain

Earliest CTIS Part Ii Submission Date
03-07-2024
Latest Decision Or Authorization Date
24-10-2025
Processing Time Days
478
Number Of Sites
9
Number Of Participants
16

Sites

Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Gastroenterologia y Hepatologia
Contact Person Name
María Teresa Arias Loste
Contact Person Email
ariasloste@gmail.com
Site Name
Hospital Universitario La Paz
Department Name
Servicio de Gastroenterologia y Hepatologia
Contact Person Name
Antonio Olveira Martín
Site Name
Hospital General De Tomelloso
Department Name
Servicio de Gastroenterología y Hepatología
Contact Person Name
Alfredo Lucendo Villarín
Contact Person Email
alucendo@sescam.jccm.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Servicio de Hepatología
Contact Person Name
Manuel Romero-Gómez
Contact Person Email
mromerogomez@us.es
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Servicio de Endocrinología
Contact Person Name
Alfonso Soto González
Contact Person Email
asotog10@yahoo.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Servicio de Digestivo
Contact Person Name
Luis Ibáñez Samaniego
Contact Person Email
luis.ibanez@salud.madrid.org
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Servicio de Hepatología
Contact Person Name
Esther Molina Pérez
Contact Person Email
esther.Molina.Perez@sergas.es
Site Name
Hospital Clinico Universitario De Valladolid
Department Name
Servicio de Digestivo
Contact Person Name
Rocío Aller de la Fuente
Contact Person Email
rallerf@saludcastillayleon.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Servicio de Hepatología
Contact Person Name
Juan Manuel Pèricas

France

Earliest CTIS Part Ii Submission Date
05-07-2024
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
585
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hepato-gastroenterology department
Contact Person Name
Paul Hermabessiere
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Hepato-gastro-enterology department
Contact Person Name
Rémi Colin
Contact Person Email
remi.collin@chu-limoges.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
hepato-gastroenterology and digestive oncology reference center
Contact Person Name
Albert Tran
Contact Person Email
tran.a@chu-nice.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hepatology department
Contact Person Name
Laurent Castera
Contact Person Email
laurent.castera@aphp.fr
Site Name
Hopital De La Croix-Rousse
Department Name
Hepato-gastro-enterology department
Contact Person Name
Massimo Levrero
Contact Person Email
massimo.levrero@gmail.com

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Parexel International Corp.
Responsibilities
EUB Services (call center and medical services)
Name
Almac Clinical Services LLC
Name
Signant Health LLC

Third parties

  • {"country":"United States","full_name":"AG Mednet Inc.","duties_or_roles":"Adjudication Services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB Services (call center and medical services)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Echosens","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Perspectum Limited","duties_or_roles":"MRI-PDFF and CTI","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
efinopegdutide
Active Substance
EFINOPEGDUTIDE
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
Subcutaneous injection
Maximum Dose
10 mg (max daily as listed: maxDailyDoseAmount 10 mg)

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