A Study of Efimosfermin Alfa in Adults With Hepatic Impairment

NCT07358546 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 306836
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

efimosfermin alfa; Alcohol; Hepatic Impairment; Steatotic liver disease; Metabolic Dysfunction-Associated Steatohepatitis; Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Area under the serum drug concentration versus time curve from time zero to infinity (AUC[0-inf]) of efimosfermin alfa

  Up to 90 Days

• Maximum observed serum drug concentration (Cmax) of efimosfermin alfa

  Up to 90 Days

Secondary Outcomes (10)

• Number of participants with Adverse Events (AEs), treatment related AEs and serious adverse events (SAEs)

  Up to 90 Days

• Number of participants with clinically significant changes in hematology, chemistry, and urinalysis parameters

  Up to 90 Days

• Number of participants with clinically significant changes in Vital signs and 12-lead electrocardiogram (ECG) findings

  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

  Up to 90 Days

• Time to maximum observed serum drug concentration (Tmax) of efimosfermin alfa

  Up to 90 Days

Study Arms (3)

Efimosfermin alfa in participants with moderate hepatic impairment due to MASH without alcohol

EXPERIMENTAL

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 in participants with moderate hepatic impairment due to MASH with alcohol

EXPERIMENTAL

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 in severe hepatic impairment participants due to MASH regardless of alcohol use

EXPERIMENTAL

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

Interventions

Efimosfermin alfa DRUG

Efimosfermin alfa to be administrated subcutaneously

Efimosfermin alfa in participants with moderate hepatic impairment due to MASH with alcohol; Efimosfermin alfa in participants with moderate hepatic impairment due to MASH without alcohol; Efimosfermin alfa in severe hepatic impairment participants due to MASH regardless of alcohol use

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Rialto, California, 92377, United States

RECRUITING

GSK Investigational Site

Tampa, Florida, 33603, United States

RECRUITING

GSK Investigational Site

San Antonio, Texas, 78215, United States

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: open-label study
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: March 13, 2026
• Primary Completion (Estimated): October 13, 2027
• Study Completion (Estimated): October 13, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

US (3)