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

JRCT ID: jRCT2031240217

Registered date:12/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Compensated Cirrhosis Secondary to Metabolic Dysfunction-Associated Steatohepatitis
• Date of first enrollment: 22/08/2024
• Target sample size: 80
• Countries of recruitment: USA,Japan,Canada,Japan,Puerto Rico,Japan,Colombia,Japan,United Kingdom,Japan,Spain,Japan,Israel,Japan,France,Japan,Thailand,Japan,Austria,Japan
• Study type: Interventional
• Intervention(s): MK-6024 or placebo is given as a subcutaneous injection using a single-use prefilled syringe, once per week for 28 weeks

Outcome(s)

Primary Outcome

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

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Iwamoto Taro
• Secondary ID(s): NCT06465186