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)
Recruiting
Phase 3
Interventional Study
Metabolic Dysfunction-associated Steatohepatitis
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 380 (estimated)
- Sponsor
- GlaxoSmithKline · Industry
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About This Trial
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 Locations
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Eligibility 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…
Contacts