A Study of Efimosfermin Alfa in Adults With Hepatic Impairment

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

A Study of Efimosfermin Alfa in Adults With Hepatic Impairment (NCT07358546) is a Phase 1 interventional studying Non-alcoholic Fatty Liver Disease, sponsored by GlaxoSmithKline. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Non-alcoholic Fatty Liver Disease, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 32 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 (\>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. Who Should NOT Join This Trial: - History of extrahepatic disorders possibly related to etiology of cirrhosis. - History of cryoglobulinemia. - Participants with Grade 3 - 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 - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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 (\>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 * 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 * 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 of * History of pancreatic injury, pancreatitis, or other pancreatic disease. * History of liver transplantation. * 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- * 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 x upper limit of normal (ULN) * Average of triplicate corrected QT interval, (QTc) \>480 msec in (for male and female participants)participants with bundle branch block at Day -1 (Visit 2) (a mean of triplicate measurements should be used to confirm that the participant meets exclusion criterion). * For participants in the MASH with alcohol category, significant risk of withdrawal symptoms:

Treatments Being Tested

DRUG

Efimosfermin alfa

Efimosfermin alfa to be administrated subcutaneously

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

GSK Investigational Site

Rialto, California, United States

GSK Investigational Site

San Antonio, Texas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07358546), the sponsor (GlaxoSmithKline), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07358546 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07358546?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07358546?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07358546. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07358546. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.