Clinical Trials List
Protocol Number306837
NCT Number(ClinicalTrials.gov Identfier)NCT07791043
Not yet recruiting
2026-10-01 - 2030-04-08
Phase II
Not yet recruiting4
A Dose-finding, Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of Treatment with Efimosfermin Alfa in Adult Participants with Alcohol-related Liver Disease (ALD) (ALLSTAR)
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Trial Applicant
GlaxoSmithKline
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Sponsor
GLAXOSMITHKLINE FAR EAST B.V., TAIWAN BRANCH (NETHERLANDS)
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/11
Investigators and Locations
Co-Principal Investigator
- Ming-Lun Yeh Digestive System Department
- 梁博程 Digestive System Department
- Jee-Fu Huang Digestive System Department
- Chung-Feng Huang Digestive System Department
- Wan-Long Chuang Digestive System Department
- 王志文 Digestive System Department
- 魏鈺儒 Digestive System Department
- Chia-Yen Dai Digestive System Department
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Liver Diseases, Alcoholic
Objectives
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.
Test Drug
Efimosfermin Alfa (GSK6519754)
Placebo to Match Efimosfermin Alfa (GSK6519754)
Placebo to Match Efimosfermin Alfa (GSK6519754)
Active Ingredient
Efimosfermin alfa
NA
NA
Dosage Form
Injection
Dosage
150 mg
NA
NA
Endpoints
Change from Baseline in vibration-controlled transient elastography-liver stiffness measurement (VCTE-LSM) VCTE-LSM is a non-invasive test that uses vibration-controlled transient elastography to measure the stiffness of the liver in kilopascals (kPa) Baseline (Day 1) and up to Week 60
Change from Baseline in model for end-stage liver disease (MELD) score MELD is a scoring system for assessing the severity of chronic liver disease. MELD scores range between 6 and 40, with 40 being the most severe. Baseline (Day 1) and up to Week 60
Change from Baseline in model for end-stage liver disease (MELD) score MELD is a scoring system for assessing the severity of chronic liver disease. MELD scores range between 6 and 40, with 40 being the most severe. Baseline (Day 1) and up to Week 60
Inclution 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.
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).
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).
The Estimated Number of Participants
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Taiwan
12 participants
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Global
274 participants
