Last updated: 07/10/2026 08:20:20

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

GSK study ID
308623
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
2026-525757-37
Trial status
Not yet recruiting
Not yet recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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)
Trial 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Part A: Proportion of participants achieving improvement in liver fibrosis by >=1 stage and no worsening of MASH

Timeframe: At Week 96

Secondary outcomes:

Part A: Proportion of participants achieving change from Baseline in vibration-controlled transient elastography (VCTE)- liver stiffness measurement (LSM) and in enhanced liver fibrosis (ELF) score

Timeframe: Baseline (Day 1) and Week 96

Part A Change from Baseline in VCTE-LSM

Timeframe: Baseline (Day 1) and Week 96

Part A: Proportion of participants with Treatment-Emergent Adverse Events (TEAEs) and TEAEs by severity

Timeframe: Week 96

Part A: Proportion of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity

Timeframe: Week 96

Part A: Proportion of participants with Grade 3 and Grade 4 laboratory abnormalities

Timeframe: Week 96

Interventions:
Drug: Efimosfermin alfa
Drug: Placebo
Enrollment:
380
Observational study model:
Not applicable
Primary completion date:
2030-14-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Metabolic Dysfunction-Associated Steatohepatitis
Product
Not applicable
Collaborators
Not applicable
Study date(s)
July 2026 to December 2033
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
18 - 75 Years
Accepts healthy volunteers
No
  • Participants aged between 18 and 75 years at enrolment.
  • Participants with history or presence of at least two components of metabolic syndrome.
  • Participants with other chronic liver diseases.
  • Participants with evidence or history of decompensated liver disease or hepatocellular carcinoma.
Inclusion and exclusion criteria
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

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Not yet recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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