New drug tested in patients with fatty liver and cirrhosis
NCT ID NCT07358546
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a single dose of an experimental drug called efimosfermin alfa in 32 adults with fatty liver disease and varying degrees of liver damage. The goal is to see how the drug moves through the body and whether it is safe. Participants must have liver cirrhosis and be between 18 and 70 years old.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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GSK Investigational Site
RECRUITINGRialto, California, 92377, United States
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GSK Investigational Site
RECRUITINGTampa, Florida, 33603, United States
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GSK Investigational Site
RECRUITINGSan Antonio, Texas, 78215, United States
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Other studies related to the condition(s) this trial covers.
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