NCT07701993RecruitingPhase 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)
A Phase 3, Double-blind, Randomized, Placebo Controlled, 2-arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Injection in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (NEBULA-1)
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1740 (estimated)
- First submitted
- 9 Jul 2026
- Start date
- 22 Jul 2026
- Primary completion date
- 23 Jun 2033
- Lead sponsor
- GlaxoSmithKline
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07701993
- EudraCT number
- 2026-525755-82
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1740
- From 22 Jul 2026 to the primary completion date, 23 Jun 2033
- 13 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
- 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.
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 complications.
- Participants with current or history of excessive alcohol intake.
Lab values
- Participants with 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 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GSK Investigational Site Coordinator of this site? Confirm its status | Kawasaki-shi | Japan | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Ōgaki | Japan | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Arlington | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Bellaire | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Folsom | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Humble | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Ocala | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.