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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)

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)

Who can join

Ages 18 to 75 · All sexes

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

About the study

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.

What is being tested

• Efimosfermin alfa (drug)
• Placebo (drug)

Sponsor: GlaxoSmithKline · Participants: 380 · Started: Jul 22, 2026

Contact the study team

• US GSK Clinical Trials Call Center · Phone: 877-379-3718
• EU GSK Clinical Trials Call Center · Phone: +44 (0) 20 89904466

Official record on ClinicalTrials.gov — NCT07704892

Locations in the U.S.

Conditions

• Steatotic Liver Disease

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.