A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) MASH

Boston Scientific

Status and phase: Enrolling; Phase 2

Conditions: Metabolic Dysfunction-Associated Steatohepatitis

Treatments: Drug: Efimosfermin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06920043

BOS-580-202

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ability to understand and sign a written informed consent form (ICF)
• Age 18 through 75 years at enrollment
• History or presence of 2 or more of the 5 components of metabolic syndrome
• Liver biopsy confirmation of MASH consistent with stage F4 fibrosis
• Other inclusion criteria may apply.

Exclusion criteria

• Individuals with chronic liver disease from other causes, or any history or evidence of decompensated liver disease
• History of type 1 diabetes
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × the upper limit of normal (ULN)
• Other exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 3 patient groups, including a placebo group

Efimosfermin (Dose 1)

Experimental group

Description:

Participants will receive efimosfermin (Dose 1) once every 4 weeks (Q4W).

Treatment:

Drug: Efimosfermin

Efimosfermin (Dose 2)

Experimental group

Description:

Participants will receive efimosfermin (Dose 2) Q4W.

Treatment:

Drug: Efimosfermin

Placebo

Placebo Comparator group

Description:

Participants will receive placebo Q4W.

Treatment:

Drug: Placebo