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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
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

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
GSK Investigational Site
Coordinator of this site? Confirm its status
Kawasaki-shiJapanRecruiting
GSK Investigational Site
Coordinator of this site? Confirm its status
ŌgakiJapanRecruiting
GSK Investigational Site
Coordinator of this site? Confirm its status
ArlingtonUnited StatesRecruiting
GSK Investigational Site
Coordinator of this site? Confirm its status
AustinUnited StatesRecruiting
GSK Investigational Site
Coordinator of this site? Confirm its status
BellaireUnited StatesRecruiting
GSK Investigational Site
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
GSK Investigational Site
Coordinator of this site? Confirm its status
FolsomUnited StatesRecruiting
GSK Investigational Site
Coordinator of this site? Confirm its status
HumbleUnited StatesRecruiting
GSK Investigational Site
Coordinator of this site? Confirm its status
Little RockUnited StatesRecruiting
GSK Investigational Site
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
GSK Investigational Site
Coordinator of this site? Confirm its status
OcalaUnited StatesRecruiting
GSK Investigational Site
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
GSK Investigational Site
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.