Efimosfermin alfa vs placebo for adult alcohol-related liver disease (ALD)

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 is a phase 2, dose-ranging study to assess safety and gather early evidence that efimosfermin alfa may benefit adults with alcohol-related liver disease. Participants will be assigned to efimosfermin alfa or placebo to observe safety signals and preliminary efficacy. The study will monitor liver-related outcomes and other health measures over a defined treatment period. It is conducted at a few GSK investigational sites in the United States. Eligible adults have a history of heavy alcohol use and meet criteria to participate, including contraception considerations for women of childbearing potential.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participant must be 18 to 75 years of age inclusive, at the time of Screening.
* Capable of giving signed informed consent prior to the performance of any study-specific procedures.
* Able and willing to comply with all study assessments and adhere to the protocol schedule of activities.
* History of heavy alcohol consumption for greater than 6 months at any time prior to Screening.
* A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:

  * Is a Participant of non-childbearing potential (PONCBP) OR
  * Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\<)1 percentage (%), 30 days prior to and during the study intervention period and for at least 16 weeks after the last dose of study intervention.

Exclusion Criteria:

* Other primary causes of liver disease (e.g., viral hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, hemochromatosis, alpha-1-antitryspin deficiency, etc.). Alcohol must be the primary cause of liver disease.
* Co-infection with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV) as indicated from the central lab
* History of diabetes mellitus (DM), either:

  * Type 1 DM
  * Type 2 DM with unstable glycemic control or with major complications.
* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the 3 years prior to Screening 1, regardless of any evidence of local recurrence or metastasis.
* Current, or history of known hepatocellular carcinoma (HCC).
* Any major surgery within 3 months prior to Screening 1 or planned during the study
* Any surgical or medical condition that might jeopardize the individual's safety or compliance with study procedures in the opinion of the investigator.
* All organ transplant recipients, except for history of corneal transplants, or current listing or active consideration for liver transplant during the Screening period.
* Poorly controlled hypertension.
* Evidence of Wernicke-Korsakoff syndrome or alcohol-related dementia.
* Prior use of a Fibroblast growth factor 21 (FGF21) analogue, including efimosfermin, within the 6 months prior to Screening 1.
* Individuals with a history of resmetirom use within 3 months prior to Day 1 are to be excluded.
* Concomitant use of investigational drugs for Metabolic dysfunction-associated steatohepatitis (MASH) or ALD.
* Current or planned participation in any clinical trial of investigational therapies or medical devices.
* Exceeding pre-defined laboratory parameters for Triglycerides, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), International normalised ratio (INR), Albumin, Urine albumin-creatinine ratio (uACR) or Glycosylated Hemoglobin (HbA1c).
* History of drug abuse within the 12 months prior to Day 1 or evidence of such abuse as indicated by laboratory assays conducted at Screening.
* History of hypersensitivity (such as anaphylaxis or hepatotoxicity) to study intervention and/or its excipients, drugs of similar biological class, FGF21 protein analogs, Fc-fusion proteins, or other protein-based therapeutics.
* Overt hepatic encephalopathy (West Haven grade \>=2).

Where it's running

• GSK Investigational Site
  Chandler, Arizona, United States Recruiting
• GSK Investigational Site
  Miami Lakes, Florida, United States Recruiting
• GSK Investigational Site
  Topeka, Kansas, United States Recruiting
• GSK Investigational Site
  Fort Worth, Texas, United States Recruiting
• GSK Investigational Site
  San Antonio, Texas, United States Recruiting
• GSK Investigational Site
  Buenos Aires, Argentina Recruiting

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.