Phase 3: testing Efimosfermin Alfa for Non-alcoholic Fatty Liver Disease
This study will measure the whether it is safe and how hard side effects are to live with of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.
Official registry: https://clinicaltrials.gov/study/NCT07221188 · GlaxoSmithKline · enrollment listed as 1,250
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
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, or Placebo. The registry lists allocation as randomized. This study will measure the whether it is safe and how hard side effects are to live with of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.
They plan to enroll about 1,250 people at 55 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)
Interventions: Efimosfermin Alfa, Placebo
Primary outcome (registry wording): Number of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severity
Who it is for (from inclusion criteria)
- Ages 18 Years to 75 Years
- Age \>=18 through \<=75 years at enrolment
- History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition
- History or presence of known or suspected MASH with evidence of fibrosis
Who the registry excludes
- ALT or AST \>=5 × upper limit of normal (ULN)
- Serum albumin \<=3.5 grams per deciliter (g/dL)
- International normalized ratio (INR) \>=1.3 not due to therapeutic anticoagulation. Individuals receiving chronic anticoagulant treatment with higher INR values may be enrolled at the discretion of the Investigator and Study Medical Monitor
- Alkaline phosphatase (ALP) \>=2 × ULN
- Platelet (PLT) count \<140 000 per (/) cubic millimeter (mm\^3); individuals with a PLT count between 110,000/mm\^3 and 140,000/mm\^3 may be enrolled after discussion with the Study Medical Monitor
- Serum creatinine \>=1.5 mg/dL or creatinine clearance \<=60 milliliter (mL)/minute (min)/1.73 square meter by Chronic Kidney Disease Epidemiology Collaboration equation
- Alpha-fetoprotein \>=20 nanogram per milliliter (ng/mL)
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
55 listed- GSK Investigational Site — Arcadia, California (recruiting)
- GSK Investigational Site — Covina, California (recruiting)
- GSK Investigational Site — Los Angeles, California (recruiting)
- GSK Investigational Site — San Diego, California (recruiting)
- GSK Investigational Site — Santa Maria, California (recruiting)
- GSK Investigational Site — Van Nuys, California (recruiting)
- GSK Investigational Site — Boynton Beach, Florida (recruiting)
- GSK Investigational Site — Cape Coral, Florida (recruiting)
- GSK Investigational Site — Clermont, Florida (recruiting)
- GSK Investigational Site — Doral, Florida (recruiting)
- GSK Investigational Site — Fort Myers, Florida (recruiting)
- GSK Investigational Site — Hialeah, Florida (recruiting)
+ 8 sites outside the US on the same record
FAQ about this NCT record
Is NCT07221188 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 NCT07221188?
Phase 3. 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 NCT07221188?
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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