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Recruiting Phase 3

A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH

NCT07221188 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2025-12-12
Last updated
2026-09-17

Condition(s) studied

Non-alcoholic Fatty Liver Disease

Investigational drug(s) / intervention(s)

Efimosfermin Alfa →Placebo

Efimosfermin Alfa: Efimosfermin Alfa will be administered

Placebo: Placebo will be administered

Study summary

This study will evaluate the safety and tolerability of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Able and willing to understand and sign a written informed consent form (ICF) that must be obtained prior to the initiation of study procedures * Age \>=18 through \<=75 years at enrolment * History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition * History or presence of known or suspected MASH with evidence of fibrosis Exclusion Criteria: * ALT or AST \>=5 × upper limit of normal (ULN) * Total bilirubin (BILI) \>=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total BILI of \>=1.3 mg/dL and direct BILI is \<=20% of total BILI; otherwise, the individual will be excluded. * Serum albumin \<=3.5 grams per deciliter (g/dL) * International normalized ratio (INR) \>=1.3 not due to therapeutic anticoagulation. Individuals receiving chronic anticoagulant treatment with higher INR values may be enrolled at the discretion of the Investigator and Study Medical Monitor. * Alkaline phosphatase (ALP) \>=2 × ULN * Platelet (PLT) count \<140 000 per (/) cubic millimeter (mm\^3); individuals with a PLT count between 110,000/mm\^3 and 140,000/mm\^3 may be enrolled after discussion with the Study Medical Monitor * Serum creatinine \>=1.5 mg/dL or creatinine clearance \<=60 milliliter (mL)/minute (min)/1.73 square meter by Chronic Kidney Disease Epidemiology Collaboration equation. * Alpha-fetoprotein \>=20 nanogram per milliliter (ng/mL) * HbA1c \>=9.0% * Model for End-Stage Liver Disease (MELD) 3.0 score \>=12 unless the score is elevated in the absence of liver dysfunction (eg, Gilbert's syndrome) * Phosphatidylethanol (PEth) \>=80 nanogram per milliliter (ng/mL) at Screening * Known co-infection with any of the following: a. Human immunodeficiency virus; b. Hepatitis B virus; c. Hepatitis C virus (HCV); d. Hepatitis D virus; or e. Hepatitis E virus. * Chronic liver disease from any other cause including, but not limited to, alcoholic liver disease; evidence of portal hypertension; viral hepatitis, or any history or evidence of cirrhosis; or decompensated liver disease such as clinical ascites, bleeding gastroesophageal varices, hepatorenal syndrome, or hepatic encephalopathy prior to Screening or Day 1. * Current or history of excessive alcohol intake for \>=3 months within the 12-month period prior to Screening

Primary outcome measure(s)

  • Number of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severity — At Week 52
  • Number of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity — At Week 52
  • Number of participants with Grade 3 and Grade 4 laboratory abnormalities — At Week 52

Trial sites (66)

FacilityCityRegionStatus
GSK Investigational Site Arcadia California Recruiting
GSK Investigational Site Covina California Recruiting
GSK Investigational Site Los Angeles California Recruiting
GSK Investigational Site San Diego California Recruiting
GSK Investigational Site Santa Maria California Recruiting
GSK Investigational Site Van Nuys California Recruiting
GSK Investigational Site Boynton Beach Florida Recruiting
GSK Investigational Site Cape Coral Florida Recruiting
GSK Investigational Site Clermont Florida Recruiting
GSK Investigational Site Doral Florida Recruiting
GSK Investigational Site Fort Myers Florida Recruiting
GSK Investigational Site Hialeah Florida Recruiting
GSK Investigational Site Homestead Florida Recruiting
GSK Investigational Site Inverness Florida Recruiting
GSK Investigational Site Jacksonville Florida Recruiting
GSK Investigational Site Kissimmee Florida Recruiting
GSK Investigational Site Lakeland Florida Recruiting
GSK Investigational Site Maitland Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Lakes Florida Recruiting
GSK Investigational Site Ocala Florida Recruiting
GSK Investigational Site Palmetto Bay Florida Recruiting
GSK Investigational Site Sarasota Florida Recruiting
GSK Investigational Site Topeka Kansas Recruiting
GSK Investigational Site Marrero Louisiana Recruiting
GSK Investigational Site Springfield Missouri Recruiting
GSK Investigational Site St Louis Missouri Recruiting
GSK Investigational Site St Louis Missouri Recruiting
GSK Investigational Site Jersey City New Jersey Recruiting
GSK Investigational Site East Syracuse New York Recruiting
GSK Investigational Site New York New York Recruiting
GSK Investigational Site Morehead City North Carolina Recruiting
GSK Investigational Site Akron Ohio Recruiting
GSK Investigational Site Springboro Ohio Recruiting
GSK Investigational Site Chattanooga Tennessee Recruiting

+ 26 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07221188 on ClinicalTrials.gov ↗ ← All trials in the USA