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)

Study acronym: NEBULA-2
StatusRecruiting
PhasePhase 3
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 12 → 20 locations
  2. Trial sites expanded: 2 → 11 locations
  3. Primary endpoints: details revised at 1 of 1 entry
    • Study sites: 2 to 11
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 5 entries
  4. Recruitment openedv2 Show 4 more changesShow less
    • Study sites: 0 to 2
    • Primary completion date: Oct 14, 2030 to Oct 16, 2030
    • Study completion date: Dec 6, 2033 to Dec 8, 2033
    • Start date changed from estimate of Jul 20, 2026 to Jul 22, 2026
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
GlaxoSmithKline
246 trials monitored
See 20 trials at risk
NASH / MASH
690 trials monitored
See 23 trials at risk
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.
Trial Details
NCT Number NCT07704892
Lead Sponsor GlaxoSmithKline
Conditions
(from sponsor)		 Metabolic Dysfunction-associated Steatohepatitis
Related terms Fatty Liver, Fibrosis
Enrollment 380 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov