A Study of Efimosfermin Alfa in Adults With Hepatic Impairment

June 5, 2026 updated by: GlaxoSmithKline

A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of Efimosfermin Alfa in Adults With Varying Degrees of Hepatic Impairment Due to Steatotic Liver Disease

This study is designed to study the pharmacokinetic (PK) and safety profiles of a single dose of efimosfermin alfa in participants with varying degrees of Hepatic Impairment (HI) (assessed by Child-Pugh score) due to steatotic liver disease, with and without significant alcohol consumption.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Rialto, California, United States, 92377
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Zeid Kayali
        • Contact:
        • Contact:
    • Florida
      • Tampa, Florida, United States, 33603
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jesus Navarro
        • Contact:
        • Contact:
    • Texas
      • San Antonio, Texas, United States, 78215
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Eric Lawitz
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Between 18 years and 70 years of age inclusive
  • Body Mass Index (BMI) within the range 23-40 kilogram per square meter (kg/m^2)
  • Male or female participants

  • Participant has liver cirrhosis with a grade of hepatic impairment that can be classified as a discrete Child-Pugh class. Participants must:

    • Have a clinical diagnosis of liver cirrhosis in the participant's medical history corroborated by previous liver biopsy, medical imaging or compatible biochemical profile, and

    • Be classed during Screening as one of the following Child-Pugh classes:

      • Child-Pugh B: Score 7-9 or
      • Child-Pugh C: Score 10-15
  • Chronic (greater than [>] 6 months) HI which is currently stable (no acute episodes of illness within the previous 1 month prior to Screening (Visit 1) due to deterioration in hepatic function). Participants must also remain stable throughout the Screening period. Assessment of the stability of the participant's hepatic function will be determined by the investigator.

Exclusion Criteria:

  • History of extrahepatic disorders possibly related to etiology of cirrhosis.
  • History of cryoglobulinemia.
  • Participants with Grade 3 ascites or refractory ascites.
  • Participants with refractory encephalopathy or significant central nervous system disease
  • History of gastric or esophageal variceal bleeding within the past 6 months and for which varices have not been adequately treated with medication and/or surgical procedures.
  • Other primary causes of liver disease. Steatotic liver disease must be the primary cause of liver disease.
  • Clinically significant abnormalities affecting physical health in medical history, or on physical examination, that could interfere with or for which treatment could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participant in this study.
  • Current, or history of known hepatocellular carcinoma (HCC).
  • Participants with transjugular intrahepatic portosystemic shunt (TIPS) placement.
  • Presence of hepatopulmonary or hepatorenal syndrome.
  • Presence of primarily cholestatic liver diseases.
  • Evidence of symptomatic or complicated cholecystitis.
  • History of pancreatic injury, pancreatitis, or other pancreatic disease.
  • History of liver transplantation, or active on the liver transplant waiting list.
  • Participants with signs of active infection
  • History of adrenal gland disease or using treatment that affects the hypothalamic-pituitary-adrenal axis.
  • History of significant bone disease such as osteoporosis
  • Psychosocial features that, in the opinion of the investigator, increase the likelihood of loss to follow-up.
  • History or presence of drug abuse.
  • Use of other investigational drugs at the time of screening, or within 5 half-lives or 30 days prior to study intervention, whichever was longer; or longer if required by local regulations
  • Have previously taken efimosfermin alfa
  • Participants with Alanine Aminotransferase (ALT) value >3 times (x) upper limit of normal (ULN)
  • Participants with Aspartate aminotransferase (AST) value >=300 Units/Liter.
  • Participants with estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology [CKD-Epi] 2021) <45 milliliter/minute/1.73 square meter (mL/min/1.73m^2).
  • Average of triplicate QT interval corrected for heart rate using Fridericia formula (QTcF) >480 milliseconds (msec) (for male and female participants) at Screening
  • For participants in the MASH with alcohol category, significant risk of withdrawal symptoms.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Efimosfermin alfa in participants with moderate hepatic impairment due to MASH without alcohol
All participants will receive efimosfermin alfa. Participants will have moderate hepatic impairment (Child-Pugh B) due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) with typical alcohol consumption threshold in the 3 months prior to Screening of less than (<) 5 standard drinks on any day and <15 standard drinks per week for men; or <4 standard drinks on any day and <8 standard drinks per week for women.
Drug: Efimosfermin alfa
Efimosfermin alfa to be administrated subcutaneously
Experimental: Efimosfermin alfa in participants with moderate hepatic impairment due to MASH with alcohol
All participants will receive efimosfermin alfa. Participants will have moderate hepatic impairment (Child-Pugh B) due to MASH with typical alcohol consumption threshold in the 3 months prior to Screening of greater than or equal to (>=) 5 standard drinks per day or >=15 standard drinks per week for men; or >= 4 standard drinks per day or >=8 or more drinks per week for women.
Drug: Efimosfermin alfa
Efimosfermin alfa to be administrated subcutaneously
Experimental: Efimosfermin alfa in severe hepatic impairment participants due to MASH regardless of alcohol use
All participants will receive efimosfermin alfa. Participants will have severe hepatic impairment (Child-Pugh C) due to MASH with any typical daily alcohol consumption.
Drug: Efimosfermin alfa
Efimosfermin alfa to be administrated subcutaneously

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Area under the serum drug concentration versus time curve from time zero to infinity (AUC[0-inf]) of efimosfermin alfa
Time Frame: Up to 90 Days
Up to 90 Days
Maximum observed serum drug concentration (Cmax) of efimosfermin alfa
Time Frame: Up to 90 Days
Up to 90 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Apparent clearance (CL/F) of efimosfermin alfa
Time Frame: Up to 90 days
Up to 90 days
Number of participants with Adverse Events (AEs), treatment related AEs and serious adverse events (SAEs)
Time Frame: Up to 90 Days
Up to 90 Days
Area under the serum drug concentration versus time curve from time zero to the time of the last quantifiable concentration (AUC[0-t]) of efimosfermin alfa
Time Frame: Up to 90 Days
Up to 90 Days
Time to maximum observed serum drug concentration (Tmax) of efimosfermin alfa
Time Frame: Up to 90 Days
Up to 90 Days
Apparent terminal phase half-life (t1/2) of efimosfermin alfa
Time Frame: Up to 90 Days
Up to 90 Days
Time prior to the first measurable (non-zero) serum concentration (Tlag) of efimosfermin alfa
Time Frame: Up to 90 Days
Up to 90 Days
Apparent terminal phase volume of distribution (Vz/F) of efimosfermin alfa
Time Frame: Up to 90 days
Up to 90 days
Terminal elimination rate constant (Lambda z) of efimosfermin alfa
Time Frame: Up to 90 days
Up to 90 days
Number of participants with clinically significant changes in hematology, chemistry, and urinalysis parameters
Time Frame: Up to 90 Days
Up to 90 Days
Number of participants with clinically significant changes in Vital signs and 12-lead electrocardiogram (ECG) findings
Time Frame: Up to 90 Days
Up to 90 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 13, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 13, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 306836

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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