NCT07704892RecruitingPhase 3
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)
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)
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 380 (estimated)
- First submitted
- 10 Jul 2026
- Start date
- 22 Jul 2026
- Primary completion date
- 16 Oct 2030
- Lead sponsor
- GlaxoSmithKline
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07704892
- EudraCT number
- 2026-525757-37
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 380
- From 22 Jul 2026 to the primary completion date, 16 Oct 2030
- 18 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Lab values
- Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \>= 5 times upper limit normal (ULN).
Who the study is looking for
- 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).
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.