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)

Study acronym: NEBULA-1
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Trial sites expanded: 7 → 15 locations
  2. Study sites: 6 to 7
  3. Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 9 of 18 entries
    • Site details revised at 1 of 6 sites
  4. Trial sites expanded: 1 → 6 locations
    • Primary completion moved earlier from Jul 27, 2033 to Jun 23, 2033
    v3
  5. Recruitment openedv2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Jul 25, 2033 to Jul 27, 2033
    • Study completion date: Aug 22, 2033 to Aug 24, 2033
    • Start date changed from estimate of Jul 20, 2026 to Jul 22, 2026
  6. 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 study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.
Trial Details
NCT Number NCT07701993
Lead Sponsor GlaxoSmithKline
Conditions
(from sponsor)		 Metabolic Dysfunction-associated Steatohepatitis
Related terms Fatty Liver, Fibrosis
Enrollment 1,740 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov