Phase 1: testing Efimosfermin alfa for Non-alcoholic Fatty 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.
Official registry: https://clinicaltrials.gov/study/NCT07358546 · GlaxoSmithKline · enrollment listed as 32
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Efimosfermin alfa. The registry lists allocation as randomized. 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.
They plan to enroll about 32 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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
Interventions: Efimosfermin alfa
Primary outcome (registry wording): Area under the serum drug concentration versus time curve from time zero to infinity (AUC[0-inf]) of efimosfermin alfa
Who it is for (from inclusion criteria)
- Ages 18 Years to 70 Years
- Between 18 years and 70 years of age inclusive
- Body Mass Index (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
Who the registry excludes
- 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
- Current, or history of known hepatocellular carcinoma (HCC)
Public study contact (from the registry)
US GSK Clinical Trials Call Center
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
5 listed- GSK Investigational Site — Rialto, California (recruiting)
- GSK Investigational Site — Miami Lakes, Florida (recruiting)
- GSK Investigational Site — Tampa, Florida (recruiting)
- GSK Investigational Site — Houston, Texas (recruiting)
- GSK Investigational Site — San Antonio, Texas (recruiting)
FAQ about this NCT record
Is NCT07358546 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07358546?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07358546?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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