臨床研究等提出・公開システム

Japanese

Date of registration	July. 12, 2024
Last modified on	Dec. 04, 2024
Trial ID	jRCT2031240217

Scientific Title	A 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
Public Title	Phase 2a Study of Efinopegdutide (MK-6024) in Adults With Compensated Cirrhosis Secondary to Metabolic Dysfunction-Associated Steatohepatitis

Contact for Scientific Queries	Name	Iwamoto Taro
	Affiliation	MSD K.K.
	Address	KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan
	Telephone	+81-3-6272-1957
	E-mail	msdjrct@merck.com
Contact for Public Queries	Name	MSDJRCT inquiry mailbox
	Affiliation	MSD K.K.
	Address	KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan
	Telephone	+81-3-6272-1957
	E-mail	msdjrct@merck.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Aug. 05, 2024
Actual date of first enrollment		Aug. 22, 2024
Target sample size		80
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1)Has compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH) 2)Has either type 2 diabetes that is controlled by diet or medication, or does not have type 2 diabetes
	Exclusion Criteria	1)Has history of a 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 3)Had a 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
	Age Minimum	18age old over
	Age Maximum	80age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Compensated Cirrhosis Secondary to Metabolic Dysfunction-Associated Steatohepatitis
Intervention(s)		MK-6024 or placebo is given as a subcutaneous injection using a single-use prefilled syringe, once per week for 28 weeks
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		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 Outcome(s)		1)Change from Baseline in Iron-corrected T1 (cT1) at Week 28 2)Change from Baseline in Enhanced Liver Fibrosis (ELF) 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

Primary Sponsor	MSD K.K.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Sugiura Clinic Institutional Review Board
Address	4-4-16-301, Hon-cho, Kawaguchi-shi, Saitama
Telephone	+81-42-648-5551
E-Mail	sugiura-irb@eps.co.jp
Approval Status	Approval
Date of approval	June. 07, 2024

Plan to share IPD	Yes
Plan description	http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Secondary ID(s)	NCT06465186
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	USA/Canada/Puerto Rico/Colombia/United Kingdom/Spain/Israel/France/Thailand/Austria

History of Changes

No	Publication date
3	Dec. 04, 2024	(this page)	Changes
2	Aug. 28, 2024	Detail	Changes
1	July. 12, 2024	Detail

List of change history