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Purpose

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

Condition

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.