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

ConditionLiver Diseases, Alcoholic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGlaxoSmithKline

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Type 1 DM

Type 2 DM with unstable glycemic control or with major complications.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Efimosfermin alfa

    Drug

    Efimosfermin alfa will be administered.

  • Placebo

    Drug

    Placebo will be administered.

Treatment groups

274 Participants
are divided into 4 treatment groups
Group A: Efimosfermin alfa Dose Level 1Experimental treatment 1 intervention
Group B: Efimosfermin alfa Dose Level 2Experimental treatment 1 intervention
Group C: Efimosfermin alfa Dose Level 3Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Baseline (Day 1) and up to Week 60
2

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.

Time frame
Baseline (Day 1) and up to Week 60

Secondary outcomes

1

Change from Baseline in serum aspartate aminotransferase (AST) (International units per liter)

This is a measurement of the AST enzyme in the blood.

Time frame
Baseline (Day 1) and up to Week 60
2

Change from Baseline in a blood test that helps predict the risk of disease progression in liver disease

Time frame
Baseline (Day 1) and up to Week 52
3

Trough Concentration at steady state (Ctrough,ss) following administration of efimosfermin alfa

Time frame
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

Time frame
Up to Week 4

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GlaxoSmithKline

Lead sponsor

Source ClinicalTrials.gov
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