Phase 2: testing Efimosfermin for Metabolic Dysfunction-Associated Steatohepatitis
This study wants to measure the safety, tolerability, preliminary how well it works, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.
Official registry: https://clinicaltrials.gov/study/NCT06920043 · GlaxoSmithKline · enrollment listed as 42
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more 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, or Placebo. The registry lists allocation as randomized. This study wants to measure the safety, tolerability, preliminary how well it works, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.
They plan to enroll about 42 people at 25 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase 2, Randomized, Double-blinded, Placebo-controlled Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
Interventions: Efimosfermin, Placebo
Primary outcome (registry wording): Number of participants with treatment emergent adverse events (TEAEs)
Who it is for (from inclusion criteria)
- Ages 18 Years to 75 Years
- Age 18 through 75 years at enrollment
- History or presence of 2 or more of the 5 components of metabolic syndrome
- Liver biopsy confirmation of MASH consistent with stage F4 fibrosis
- Other who can join may apply
Who the registry excludes
- Individuals with chronic liver disease from other causes, or any history or evidence of decompensated liver disease
- History of type 1 diabetes
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × the upper limit of normal (ULN)
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
25 listed- GSK Investigational Site — Chandler, Arizona (recruiting)
- GSK Investigational Site — Mesa, Arizona (recruiting)
- GSK Investigational Site — Tucson, Arizona (recruiting)
- GSK Investigational Site — Fresno, California (recruiting)
- GSK Investigational Site — Lancaster, California (recruiting)
- GSK Investigational Site — Pasadena, California (recruiting)
- GSK Investigational Site — Rialto, California (recruiting)
- GSK Investigational Site — Santa Maria, California (recruiting)
- GSK Investigational Site — Miami, Florida (recruiting)
- GSK Investigational Site — Viera, Florida (recruiting)
- GSK Investigational Site — Marietta, Georgia (recruiting)
- GSK Investigational Site — Baltimore, Maryland (recruiting)
FAQ about this NCT record
Is NCT06920043 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 NCT06920043?
Phase 2. 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 NCT06920043?
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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