NCT07704892 · GlaxoSmithKline
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)
(NEBULA-2)
What this study is about
This is a multi-center, randomly assigned, two-part (Part A and Part B) study investigating the safety and effectiveness 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 requirements to join will have the option to enroll in Part B (open label) of the study.
View original scientific 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.
Interventions
DRUG
Efimosfermin alfa
Efimosfermin alfa (subcutaneous injection) will be administered.
DRUG
Placebo
Placebo (subcutaneous injection) will be administered.
Primary outcome measures
Part A: Proportion of participants achieving improvement in liver fibrosis by >=1 stage and no worsening of MASH
Time frame: At Week 96
Participants experiencing improvement in liver fibrosis of \>=1 stage (based on MASH Clinical Research Network (CRN) fibrosis score) and no worsening of MASH (defined as no increase in nonalcoholic fatty liver disease activity score for ballooning, inflammation, or steatosis). MASH CRN fibrosis score ranges from 0 to 4, higher score indicates greater severity.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 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 mellitus complications.
- 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.
- Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \>= 5 times upper limit normal (ULN).
- Current or history of excessive alcohol intake
Where
- Miami, Florida
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 5, 2026 · Source of record for eligibility and locations