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NCT Number: NCT07704892

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)

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.

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Key information

Conditions

Metabolic Dysfunction-Associated Steatohepatitis Digestive System Diseases Fatty Liver Fibrosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Efimosfermin alfa

Drug

Efimosfermin alfa (subcutaneous injection) will be administered.

Placebo

Drug

Placebo (subcutaneous injection) will be administered.

Primary outcomes

  1. Part A: Proportion of participants achieving improvement in liver fibrosis by >=1 stage and no worsening of MASH

    Time frame: At Week 96

    Participants experiencing improvement in liver fibrosis of >=1 stage (based on MASH Clinical Research Network (CRN) fibrosis score) and no worsening of MASH (defined as no increase in nonalcoholic fatty liver disease activity score for ballooning, inflammation, or steatosis). MASH CRN fibrosis score ranges from 0 to 4, higher score indicates greater severity.

Secondary outcomes

  1. Part A: Proportion of participants achieving change from Baseline in vibration-controlled transient elastography (VCTE)- liver stiffness measurement (LSM) and in enhanced liver fibrosis (ELF) score

    Time frame: Baseline (Day 1) and Week 96

    VCTE-LSM is a non-invasive test that uses vibration-controlled transient elastography to measure the stiffness of the liver in kilopascal (kPa). ELF score (scale of 6.7 to 11.3 with higher scores indicative of increased fibrosis) is a blood-based noninvasive test used as a prognostic marker for disease progression.

  2. Part A Change from Baseline in VCTE-LSM

    Time frame: Baseline (Day 1) and Week 96

    VCTE-LSM is a non-invasive test that uses vibration-controlled transient elastography to measure the stiffness of the liver in kPa.

  3. Part A: Proportion of participants with Treatment-Emergent Adverse Events (TEAEs) and TEAEs by severity

    Time frame: Week 96

  4. Part A: Proportion of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity

    Time frame: Week 96

  5. Part A: Proportion of participants with Grade 3 and Grade 4 laboratory abnormalities

    Time frame: Week 96

Study contacts

Contact information is provided by the study sponsor or research team.

EU GSK Clinical Trials Call Center

CONTACT

[email protected]

+44 (0) 20 89904466

US GSK Clinical Trials Call Center

CONTACT

[email protected]

877-379-3718

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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)

Acronym: NEBULA-2

Important dates

Study start
2026
Primary completion
2030
Study completion
2033
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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