Testing efimosfermin against placebo in adults with cirrhosis from MASH
Tests efimosfermin, compared with placebo, in adults with cirrhosis caused by MASH.
Plain-language title generated from the registry record
Registry title: A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
Key facts
- Where
- Kawasaki-shi and Ōgaki, JapanSee the 2 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07704892, who can take part
Where in Japan
- Kawasaki-shiKawasaki-shi, JapanTaking people
- ŌgakiŌgaki, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- GlaxoSmithKline
- Trial code
- NCT07704892
- Record updated
- 5 November 2026
- Original description
This is a multi-center, randomized, two-part (Part A and Part B) study investigating the safety and efficacy of efimosfermin alfa in adult participants with compensated cirrhosis due to MASH. Participants who complete the treatment during Part A of the study and meet the inclusion criteria will have the option to enroll in Part B (open label) of the study.Read full original descriptionShow less
A Phase 3, Two-part, Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Injection in Adult Participants With Compensated Cirrhosis (Stage F4 Fibrosis) Due to Metabolic Dysfunction-associated Steatohepatitis (NEBULA-2)
This is a multi-center, randomized, two-part (Part A and Part B) study investigating the safety and efficacy of efimosfermin alfa in adult participants with compensated cirrhosis due to MASH. Participants who complete the treatment during Part A of the study and meet the inclusion criteria will have the option to enroll in Part B (open label) of the study.
Inclusion: Participants aged between 18 and 75 years at enrolment; Participants with history or presence of at least two components of metabolic syndrome; Liver biopsy consistent with cirrhosis (fibrosis stage 4).
Exclusion: History or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before Screening; A recent history or planned surgical procedures or medications intended to produce significant weight loss; 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 mellitus complications; Current or history of excessive alcohol intake; Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >= 5 times upper limit normal (ULN).