A Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Compared With Placebo in Adult Participants With Alcohol-related Liver Disease (ALD)

Summary

This is a dose-ranging study to evaluate safety of efimosfermin alfa and to establish proof-of-concept that efimosfermin alfa therapy provides benefit in participants with ALD.

Eligibility

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).

Conditions2

Interventions1

Locations3 sites

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