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

ClinicalTrials.gov ID

NCT07701993

Lead Sponsor

GlaxoSmithKlineINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

1,740Estimated

Last Update Posted

Sep 9, 2026Actual

Start Date

Jul 22, 2026Actual

Primary Completion Date

Jun 23, 2033Estimated

Completion Date

Aug 24, 2033Estimated

Official Title

A Phase 3, Double-blind, Randomized, Placebo Controlled, 2-arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Injection in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (NEBULA-1)

Brief Summary

This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.

• 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 enrollment.
• Participants with compensated cirrhosis due to MASH, confirmed by non-invasive assessments.
• Participants with history or presence of at least two components of metabolic syndrome.

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 complications.
• Participants with history or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before screening.
• Participants with a recent history or planned surgical procedures or medications intended to produce significant weight loss.
• Participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >=5 times upper limit normal (ULN).
• Participants with current or history of excessive alcohol intake.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

GlaxoSmithKlineINDUSTRY

GSKClinicalSupportHD@gsk.com877-379-3718

GSKClinicalSupportHD@gsk.com877-379-3718

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