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)

Purpose

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

Condition

  • Metabolic Dysfunction-associated Steatohepatitis

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
This is a double-blind study.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Participants receiving efimosfermin alfa
  • Drug: Efimosfermin alfa
    Efimosfermin alfa (subcutaneous injection) will be administered.
Placebo Comparator
Participants receiving placebo
  • Drug: Placebo
    Placebo (subcutaneous injection) will be administered.

Recruiting Locations

GSK Investigational Site
Miami, Florida 33135
Contact:
US GSK Clinical Trials Call Center
877-379-3718
GSKClinicalSupportHD@gsk.com

More Details

Status
Recruiting
Sponsor
GlaxoSmithKline

Study Contact

US GSK Clinical Trials Call Center
877-379-3718
GSKClinicalSupportHD@gsk.com