Efimosfermin alfa injections for adults with F2–F3 MASH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial enrolls adults aged 18–75 with known or suspected MASH and fibrosis consistent with stage F2 or F3. Participants receive efimosfermin alfa injections or a matching placebo and are monitored during the treatment period with regular labs and clinical assessments to record safety and tolerability outcomes. Key inclusion criteria require at least two components of metabolic syndrome, while exclusion criteria include very high liver enzymes, elevated bilirubin, low albumin, or abnormal INR. The trial is run at GSK investigational sites in Southern California and is focused on collecting adverse event, laboratory, and tolerability data to support further development.

Why it matters

Who can join: the full rules

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

Where it's running

• GSK Investigational Site
  Arcadia, California, United States Recruiting
• GSK Investigational Site
  Covina, California, United States Recruiting
• GSK Investigational Site
  Los Angeles, California, United States Recruiting
• GSK Investigational Site
  San Diego, California, United States Recruiting
• GSK Investigational Site
  Santa Maria, California, United States Recruiting
• GSK Investigational Site
  Van Nuys, California, United States Recruiting

+16 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.