A Phase 2a Study of Efinopegdutide in Adults With Compensated Cirrhosis Secondary to Metabolic Dysfunction-Associated Steatohepatitis

2024-510923-20-00 Protocol MK-6024-017 Therapeutic exploratory (Phase II) Ongoing, recruitment ended

Start 16 Sep 2024 · Status Ongoing, recruitment ended · 2 EU/EEA countries · 14 sites · Protocol MK-6024-017

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruitment ended
Participants planned 89
Countries 2
Sites 14

Metabolic Dysfunction-Associated Steatohepatitis

1. To evaluate the effect of efinopegdutide versus placebo on the relative reduction from baseline in liver fat content (LFC) after 28 weeks. 2. To evaluate the safety and tolerability of efinopegdutide.

Key facts

Sponsor
Merck Sharp & Dohme LLC
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trial duration
16 Sep 2024 → ongoing
Decision date (initial)
2024-08-08
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Merck Sharp & Dohme LLC

External identifiers

EU CT number
2024-510923-20-00
WHO UTN
U1111-1302-7589
ClinicalTrials.gov
NCT06465186

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacogenetic, Pharmacokinetic, Efficacy, Safety, Pharmacogenomic, Therapy

1. To evaluate the effect of efinopegdutide versus placebo on the relative reduction from baseline in liver fat content (LFC) after 28 weeks.
2. To evaluate the safety and tolerability of efinopegdutide.

Secondary objectives 4

  1. To evaluate the effect of efinopegdutide versus placebo on the change from baseline in corrected T1 (cT1) after 28 weeks.
  2. To evaluate the effect of efinopegdutide versus placebo on the change from baseline in enhanced liver fibrosis (ELF) score after 28 weeks
  3. To evaluate the effect of efinopegdutide versus placebo on the change from baseline in markers/composite score reflecting liver fibrosis after 28 weeks.
  4. To evaluate the effect of efinopegdutide versus placebo on the percent change from baseline in body weight after 28 weeks.

Conditions and MedDRA coding

Metabolic Dysfunction-Associated Steatohepatitis

VersionLevelCodeTermSystem organ class
24.1 PT 10053219 Non-alcoholic steatohepatitis 100000004871

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

  1. Has compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH)
  2. Has either type 2 diabetes mellitus (T2DM) that is controlled by diet or medication, or does not have type 2 diabetes mellitus

Exclusion criteria 5

  1. Has a history of liver disease other than MASH, for example, Hepatitis B or C, drug-induced liver disease, or autoimmune liver disease
  2. Has history of type 1 diabetes mellitus (T1DM)
  3. Had bariatric surgical procedure less than 5 years before entry into the study
  4. History of pancreatitis
  5. 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 and secondary outcome measures (English text)

Primary endpoints 3

  1. Change from baseline in liver fat content (LFC) at week 28
  2. Percentage of participants who experienced an adverse event (AE)
  3. Percentage of participants discontinuing study medication due to an AE

Secondary endpoints 6

  1. Change from baseline in iron-corrected T1 (cT1) at week 28
  2. Change from baseline in enhanced liver fibrosis (ELF) score at week 28
  3. Change from baseline in propeptide of type III collagen (Pro-C3) at week 28
  4. Change from baseline in fibrosis-4 index (FIB-4) at week 28
  5. Change from baseline in liver stiffness measurement (LSM) assessed by vibration-controlled transient elastography (VCTE) at week 28
  6. Percent change from baseline in body weight at week 28

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

efinopegdutide

PRD9386877 · Product

Active substance
Efinopegdutide
Substance synonyms
HM12525A, HM-12525A, JNJ-64565111, MK-6024
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
10 mg milligram(s)
Max total dose
212 mg milligram(s)
Max treatment duration
28 Week(s)
Authorisation status
Not Authorised
MA holder
MERCK & CO. INC.
Paediatric formulation
No
Orphan designation
No

efinopegdutide

PRD10228843 · Product

Active substance
Efinopegdutide
Substance synonyms
HM12525A, HM-12525A, JNJ-64565111, MK-6024
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
10 mg milligram(s)
Max total dose
212 mg milligram(s)
Max treatment duration
28 Week(s)
Authorisation status
Not Authorised
MA holder
MERCK & CO. INC.
Paediatric formulation
No
Orphan designation
No

efinopegdutide

PRD10228842 · Product

Active substance
Efinopegdutide
Substance synonyms
HM12525A, HM-12525A, JNJ-64565111, MK-6024
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
10 mg milligram(s)
Max total dose
212 mg milligram(s)
Max treatment duration
28 Week(s)
Authorisation status
Not Authorised
MA holder
MERCK & CO. INC.
Paediatric formulation
No
Orphan designation
No

efinopegdutide

PRD10228841 · Product

Active substance
Efinopegdutide
Substance synonyms
HM12525A, HM-12525A, JNJ-64565111, MK-6024
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
10 mg milligram(s)
Max total dose
212 mg milligram(s)
Max treatment duration
28 Week(s)
Authorisation status
Not Authorised
MA holder
MERCK & CO. INC.
Paediatric formulation
No
Orphan designation
No

Placebo 1

Placebo to MK-6024

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

290 Total trials 92 Recruiting 184 Ended
Commercial
Sponsor organisation
Merck Sharp & Dohme LLC
Address
126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000
City
Rahway
Postcode
07065-4607
Country
United States

Scientific contact point

Organisation
Merck Sharp & Dohme LLC
Contact name
Annaswamy Raji

Public contact point

Organisation
Merck Sharp & Dohme LLC
Contact name
Annaswamy Raji

Third parties 7

OrganisationCity, countryDuties
AG Mednet Inc.
ORG-100039869
 Boston, United States Other
Parexel International Corp.
ORG-100007310
 Auburndale, United States Other
Labcorp Central Laboratory Services LP
ORG-100032236
 Indianapolis, United States Laboratory analysis
Echosens
ORG-100045196
 Paris, France Laboratory analysis
Signant Health LLC
ORG-100040732
 Blue Bell, United States E-data capture
Perspectum Limited
ORG-100027005
 Oxford, United Kingdom Other
Almac Clinical Services LLC
ORG-100041692
 Souderton, United States Interactive response technologies (IRT)

Locations

2 EU/EEA countries · 14 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Ongoing, recruitment ended 8 5
Spain Ongoing, recruitment ended 16 9
Rest of world
United Kingdom, United States, Puerto Rico, Colombia, Thailand, Israel, Japan, Australia, Canada
 — 65 —

Investigational sites

France

5 sites · Ongoing, recruitment ended
Centre Hospitalier Universitaire De Nice
hepato-gastroenterology and digestive oncology reference center, 151 Route De Saint Antoine, 06200, Nice
Hopital De La Croix-Rousse
Hepato-gastro-enterology department, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Assistance Publique Hopitaux De Paris
Hepatology department, 100 Boulevard Du General Leclerc, 92110, Clichy
Centre Hospitalier Et Universitaire De Limoges
Hepato-gastro-enterology department, 2 Avenue Martin Luther King, 87042, Limoges Cedex 1
Centre Hospitalier Universitaire De Bordeaux
Hepato-gastroenterology department, Avenue De Magellan, 33600, Pessac

Spain

9 sites · Ongoing, recruitment ended
Hospital General De Tomelloso
Servicio de Gastroenterología y Hepatología, Vereda De Socuellamos S/n, 13700, Tomelloso
University Hospital Virgen Del Rocio S.L.
Servicio de Hepatología, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital General Universitario Gregorio Maranon
Servicio de Digestivo, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Universitari Vall D Hebron
Servicio de Hepatología, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Complexo Hospitalario Universitario A Coruna
Servicio de Endocrinología, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario La Paz
Servicio de Gastroenterologia y Hepatologia, Paseo De La Castellana 261, 28046, Madrid
Hospital Clinico Universitario De Valladolid
Servicio de Digestivo, Avenida Ramon Y Cajal 3, 47003, Valladolid
Hospital Universitario Marques De Valdecilla
Gastroenterologia y Hepatologia, Avenida Valdecilla Sn, 39008, Santander
Complexo Hospitalario Universitario De Santiago
Servicio de Hepatología, Calle Choupana Da S/n, 15706, Santiago De Compostela

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
France 2024-10-17 2024-10-21 2025-11-20
Spain 2024-09-16 2024-10-02 2025-11-20

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 20 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol_2024-510923-20_SM07_for pub 04R
Protocol (for publication) D1_SAP_for pub outofscope
Protocol (for publication) D4_Copyright statement_EN_SM05_for pub 04DEC2024
Recruitment arrangements (for publication) K1_Recruitment Arrangements and IC Procedure_FRA_FR_SM07_for pub 27AUG2025
Recruitment arrangements (for publication) K1_Recruitment Arrangements_ESP_ES_for pub 04APR2024R
Recruitment arrangements (for publication) K2_Recruitment Doc Patient Brochure_ESP_ES_for pub 1
Recruitment arrangements (for publication) K2_Recruitment Doc Patient Brochure_FRA_FR_for pub 1
Recruitment arrangements (for publication) K2_Recruitment Doc Patient Print Ad_FRA_FR_for pub 1
Recruitment arrangements (for publication) K2_Recruitment Doc Patient Visit Procedure Guide with Calendar_FRA_FR_for pub 1
Recruitment arrangements (for publication) K2_Recruitment Doc Website_ESP_ES_SM-5_for pub 17OCT2024
Recruitment arrangements (for publication) K2_Recruitment Doc Website_FRA_FR_SM05_for pub 1
Subject information and informed consent form (for publication) L1_ICF_FBR consent_ESP_ES_for pub 00
Subject information and informed consent form (for publication) L1_ICF_FBR consent_FRA_FR_for pub 00R
Subject information and informed consent form (for publication) L1_ICF_Main addendum_FRA_FR_SM07_for pub 0.01R
Subject information and informed consent form (for publication) L1_ICF_Main consent_ESP_ES_for pub v01R
Subject information and informed consent form (for publication) L1_ICF_Main consent_FRA_FR_SM07_for pub 0.01R
Subject information and informed consent form (for publication) L1_ICF_Optional_associated person_ESP_ES_SM05_for pub 00R
Subject information and informed consent form (for publication) L1_ICF_Optional_pregnancy follow-up_ESP_ES_SM05_for pub 00
Synopsis of the protocol (for publication) D1_PPLS_2024-510923-20_for pub 1.0
Synopsis of the protocol (for publication) D1_PPLS_2024-510923-20_FRA_FR_for pub 1.0

Application history

11 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-04-16 France Acceptable
2024-08-05
 2024-08-05
2 SUBSTANTIAL MODIFICATION SM-1 2024-08-27 France Acceptable 2024-11-05
3 SUBSTANTIAL MODIFICATION SM-2 2024-08-27 Acceptable 2024-09-17
4 NON SUBSTANTIAL MODIFICATION NSM-1 2024-11-06 France Acceptable 2024-11-06
5 SUBSTANTIAL MODIFICATION SM-3 2024-11-06 France Acceptable 2025-01-30
6 SUBSTANTIAL MODIFICATION SM-4 2024-11-14 Acceptable 2024-11-21
7 SUBSTANTIAL MODIFICATION SM-5 2025-03-26 France Acceptable
2025-05-06
 2025-05-07
8 SUBSTANTIAL MODIFICATION SM-6 2025-06-11 France Acceptable 2025-07-17
9 SUBSTANTIAL MODIFICATION SM-7 2025-09-01 France Acceptable
2025-10-22
 2025-10-22
10 NON SUBSTANTIAL MODIFICATION NSM-2 2026-02-10 France Acceptable
2025-10-22
 2026-02-10
11 NON SUBSTANTIAL MODIFICATION NSM-3 2026-02-27 France Acceptable
2025-10-22
 2026-02-27

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