A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)

ClinicalTrials.gov ID

NCT07704892

Lead Sponsor

GlaxoSmithKlineINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

380Estimated

Last Update Posted

Aug 5, 2026Actual

Start Date

Jul 22, 2026Actual

Primary Completion Date

Oct 16, 2030Estimated

Completion Date

Dec 8, 2033Estimated

Official Title

A Phase 3, Two-part, Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Injection in Adult Participants With Compensated Cirrhosis (Stage F4 Fibrosis) Due to Metabolic Dysfunction-associated Steatohepatitis (NEBULA-2)

Brief Summary

This is a multi-center, randomized, two-part (Part A and Part B) study investigating the safety and efficacy of efimosfermin alfa in adult participants with compensated cirrhosis due to MASH. Participants who complete the treatment during Part A of the study and meet the inclusion criteria will have the option to enroll in Part B (open label) of the study.

• Metabolic Dysfunction-associated Steatohepatitis

• Efimosfermin alfa
• Placebo

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Participants aged between 18 and 75 years at enrolment.
• Participants with history or presence of at least two components of metabolic syndrome.
• Liver biopsy consistent with cirrhosis (fibrosis stage 4).

Exclusion Criteria:

• Participants with other chronic liver diseases.
• Participants with evidence or history of decompensated liver disease or hepatocellular carcinoma.
• Participants with history of Type 1 diabetes mellitus; or major Type 2 diabetes mellitus complications.
• History or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before Screening.
• A recent history or planned surgical procedures or medications intended to produce significant weight loss.
• Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >= 5 times upper limit normal (ULN).
• Current or history of excessive alcohol intake

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

GlaxoSmithKlineINDUSTRY

GSKClinicalSupportHD@gsk.com877-379-3718

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