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)

NCT07704892 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 3086232026-525757-37
• Study Type: interventional
• Target: 380
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Dysfunction-associated Steatohepatitis

Keywords

Cirrhosis; Efimosfermin; Fibrosis; Metabolic dysfunction-associated; Steatohepatitis

Outcome Measures

Primary Outcomes (1)

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

  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.

  At Week 96

Secondary Outcomes (5)

• 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

  Baseline (Day 1) and Week 96

• Part A Change from Baseline in VCTE-LSM

  Baseline (Day 1) and Week 96

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

  Week 96

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

  Week 96

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

  Week 96

Study Arms (3)

Part A: Participants receiving Efimosfermin alfa

EXPERIMENTAL

Participants will receive efimosfermin alfa in Part A of the study.

Drug: Efimosfermin alfa

Part A: Participants receiving Placebo

PLACEBO COMPARATOR

Participants will receive placebo in Part A of the study.

Drug: Placebo

Part B: Participants receiving Efimosfermin alfa

EXPERIMENTAL

All participants will receive efimosfermin alfa in Part B of the study.

Drug: Efimosfermin alfa

Interventions

Efimosfermin alfa DRUG

Efimosfermin alfa (subcutaneous injection) will be administered.

Part A: Participants receiving Efimosfermin alfa; Part B: Participants receiving Efimosfermin alfa

Placebo DRUG

Placebo (subcutaneous injection) will be administered.

Part A: Participants receiving Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Fibrosis; Fatty Liver

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Part A of study is a double-blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): October 14, 2030
• Study Completion (Estimated): December 6, 2033
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.