Clinical Trials in Japan / NCT07701993
Recruiting
Phase 3
A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
NCT07701993 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Metabolic Dysfunction-associated Steatohepatitis
Investigational drug(s) / intervention(s)
Efimosfermin alfa →Placebo
Efimosfermin alfa: Efimosfermin alfa (subcutaneous injection) will be administered.
Placebo: Placebo (subcutaneous injection) will be administered.
Study summary
This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.
Eligibility
Inclusion Criteria:
* Participants aged between 18 and 75 years at enrollment.
* Participants with compensated cirrhosis due to MASH, confirmed by non-invasive assessments.
* Participants with history or presence of at least two components of metabolic syndrome.
Exclusion Criteria:
* Participants with other chronic liver diseases.
* Participants with evidence or history of decompensated liver disease or hepatocellular carcinoma.
* Participants with history of Type 1 diabetes mellitus or major Type 2 diabetes complications.
* Participants with history or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before screening.
* Participants with a recent history or planned surgical procedures or medications intended to produce significant weight loss.
* Participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>=5 times upper limit normal (ULN).
* Participants with current or history of excessive alcohol intake.
Primary outcome measure(s)
- Time from randomization to an adjudicated composite liver-related clinical outcome — From Randomization (Day 1) to Week 356 (end of treatment)
Liver-related outcome comprises all-cause mortality; liver transplantation; occurrence of significant hepatic decompensation events.
Trial sites (15)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Little Rock | Arkansas | Recruiting |
| GSK Investigational Site | Folsom | California | Recruiting |
| GSK Investigational Site | Miami | Florida | Recruiting |
| GSK Investigational Site | Miami | Florida | Recruiting |
| GSK Investigational Site | Ocala | Florida | Recruiting |
| GSK Investigational Site | St Louis | Missouri | Recruiting |
| GSK Investigational Site | Arlington | Texas | Recruiting |
| GSK Investigational Site | Austin | Texas | Recruiting |
| GSK Investigational Site | Bellaire | Texas | Recruiting |
| GSK Investigational Site | Dallas | Texas | Recruiting |
| GSK Investigational Site | Humble | Texas | Recruiting |
| GSK Investigational Site | San Antonio | Texas | Recruiting |
| GSK Investigational Site | San Antonio | Texas | Recruiting |
| GSK Investigational Site | Ōgaki | Gifu | Recruiting |
| GSK Investigational Site | Kawasaki-shi | Japan | Recruiting |
More GlaxoSmithKline trials in Japan
Other trials for the same condition
Official registry record
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 NCT07701993 on ClinicalTrials.gov ↗ ← All trials in Japan