> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-investigate-the-safety-and-efficacy-of-91f539c9-56be-4516-ab19-4e536158d441 > Record changed: 2026-10-13 # A Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Compared With Placebo in Adult Participants With Alcohol-related Liver Disease (ALD) NCT07791043 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) Participants 274 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) Lead sponsor GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) Start date 2026-09-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) **Acronym** ALLSTAR Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) **Short title** A Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Compared With Placebo in Adult Participants With Alcohol-related Liver Disease (ALD) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) **Official title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) ## Dates **Completion date** 2030-02-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) **First posted** 2026-08-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) **Registry last updated** 2026-08-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) **Primary completion date** 2028-09-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) **Start date** 2026-09-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) ## Size and sites **Participants** 274 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) **Planned participants** 274 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) **Lead sponsor** GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) ## Identifiers **Registry ID** NCT07791043 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) **ClinicalTrials.gov ID** NCT07791043 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) ## Study design **Allocation** Not applicable **Model** Sequential **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) ## Outcomes ### Primary outcomes 1. Change from Baseline in vibration-controlled transient elastography-liver stiffness measurement (VCTE-LSM) Timeframe: Baseline (Day 1) and up to Week 60 VCTE-LSM is a non-invasive test that uses vibration-controlled transient elastography to measure the stiffness of the liver in kilopascals (kPa) 2. Change from Baseline in model for end-stage liver disease (MELD) score Timeframe: Baseline (Day 1) and up to Week 60 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. ### Secondary outcomes 1. Change from Baseline in serum aspartate aminotransferase (AST) (International units per liter) Timeframe: Baseline (Day 1) and up to Week 60 This is a measurement of the AST enzyme in the blood. 2. Change from Baseline in a blood test that helps predict the risk of disease progression in liver disease Timeframe: Baseline (Day 1) and up to Week 52 3. Trough Concentration at steady state (Ctrough,ss) following administration of efimosfermin alfa Timeframe: Up to Week 56 4. Area Under the concentration-time Curve from Time 0 (pre-dose) to the last quantifiable concentration (AUC\[0-t\]) of efimosfermin alfa in the subset of participants with optional intensive pharmacokinetics (PK) sampling Timeframe: Up to Week 4 5. Maximum observed drug concentration (Cmax) of efimosfermin alfa in the subset of participants with optional intensive PK sampling Timeframe: Up to Week 4 6. Number of Participants with Anti-drug antibodies (ADA) against efimosfermin alfa Timeframe: Up to Week 56 7. Number of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severity Timeframe: Up to Week 60 8. Number of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity Timeframe: Up to Week 60 9. Number of participants with Grade 3 and Grade 4 laboratory abnormalities Timeframe: Up to Week 60 10. Number of participants with clinically significant changes in Vital signs Timeframe: Up to Week 60 11. Number of participants with clinically significant changes in 12-lead electrocardiogram (ECG) findings Timeframe: Up to Week 60 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) ## References ### Other registry identifiers - 2026-526391-23 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791043) ## Related records ### Drugs (1) - [Efimosfermin alfa](https://trialight.com/data/asset/efimosfermin-alfa-15827437-369a-482c-a32a-f16bd0d25c09.md) ### Lead sponsors (1) - [GlaxoSmithKline](https://trialight.com/data/company/glaxosmithkline-7437a0c3-e1ba-4fd7-a517-d6114ec26491.md) ### Conditions (1) - [Alcoholic liver disease](https://trialight.com/data/condition/alcoholic-liver-disease-76493111-d619-5800-98d4-77d2608dccf0.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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