A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH
Condition(s) studied
Investigational drug(s) / intervention(s)
Efimosfermin alfa: Efimosfermin alfa will be administered
Efimosfermin alfa: Efimosfermin alfa will be administered
Placebo: Placebo will be administered
Study summary
The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and biopsy-confirmed F2- or F3-stage fibrosis.
Eligibility
Primary outcome measure(s)
- Proportion of participants experiencing improvement in fibrosis by >=1 stage and no worsening of steatohepatitis at Week 52 — At Week 52
Proportion of participants experiencing improvement in fibrosis of greater than or equal to (\>=) 1 stage by MASH clinical research network (CRN) fibrosis scores and no worsening of steatohepatitis (defined as no increase in nonalcoholic fatty liver disease activity score \[NAS\] for ballooning, inflammation, or steatosis) at 52 weeks will be assessed. MASH CRN fibrosis score ranges from 0 to 4, higher score indicates greater severity. NAS score ranges from 0 to 8, higher score indicates worse disease activity. - Proportion of participants experiencing resolution of steatohepatitis reading and no worsening of MASH CRN fibrosis score at Week 52 — At Week 52
Resolution of steatohepatitis is defined as absence of fatty liver disease or isolated or simple steatosis without steatohepatitis and a NAS of 0 or 1 for inflammation, 0 for ballooning, and any value for steatosis. NAS score ranges from 0 to 8, higher score indicates worse disease activity. MASH CRN fibrosis score ranges from 0 to 4, higher score indicates greater severity. - Time from randomization to an adjudicated composite liver-related clinical outcome — From Randomization (Day 1) to 48 months
Liver-related outcome will comprised of all-cause mortality; transplantation; occurrence of significant hepatic events.
Trial sites (91)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Chandler | Arizona | Recruiting |
| GSK Investigational Site | Tucson | Arizona | Recruiting |
| GSK Investigational Site | Little Rock | Arkansas | Recruiting |
| GSK Investigational Site | Arcadia | California | Recruiting |
| GSK Investigational Site | Covina | California | Recruiting |
| GSK Investigational Site | Folsom | California | Recruiting |
| GSK Investigational Site | Los Angeles | California | Recruiting |
| GSK Investigational Site | Montclair | California | Recruiting |
| GSK Investigational Site | Riverdale | 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 | Colorado Springs | Colorado | Recruiting |
| GSK Investigational Site | Boynton Beach | Florida | Recruiting |
| GSK Investigational Site | Cape Coral | Florida | Recruiting |
| GSK Investigational Site | Clermont | Florida | Recruiting |
| GSK Investigational Site | Fort Myers | Florida | Recruiting |
| GSK Investigational Site | Hialeah | Florida | Recruiting |
| GSK Investigational Site | Hialeah | Florida | Recruiting |
| GSK Investigational Site | Homestead | Florida | Recruiting |
| GSK Investigational Site | Inverness | Florida | Recruiting |
| GSK Investigational Site | Jacksonville | Florida | Recruiting |
| GSK Investigational Site | Kissimmee | Florida | Recruiting |
| GSK Investigational Site | Lakeland | Florida | Recruiting |
| GSK Investigational Site | Maitland | Florida | Recruiting |
| GSK Investigational Site | Miami | Florida | Recruiting |
| GSK Investigational Site | Miami | Florida | Recruiting |
| GSK Investigational Site | Miami | Florida | Recruiting |
| GSK Investigational Site | Miami | Florida | Recruiting |
| GSK Investigational Site | Miami | Florida | Recruiting |
| GSK Investigational Site | Miami | Florida | Recruiting |
| GSK Investigational Site | Miami | Florida | Recruiting |
| GSK Investigational Site | Miami Lakes | Florida | Recruiting |
| GSK Investigational Site | Ocala | Florida | Recruiting |
| GSK Investigational Site | Palmetto Bay | Florida | Recruiting |
| GSK Investigational Site | Sarasota | Florida | Recruiting |
| GSK Investigational Site | Marietta | Georgia | Recruiting |
| GSK Investigational Site | Topeka | Kansas | Recruiting |
| GSK Investigational Site | Bastrop | Louisiana | Recruiting |
| GSK Investigational Site | Marrero | Louisiana | Recruiting |
+ 51 more sites — see the full list on the official registry below.
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07221227 on ClinicalTrials.gov ↗ ← All trials in the USA