A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH
Recruiting
Phase 3
Interventional Study
Non-alcoholic Fatty Liver Disease
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
- 1,250 (estimated)
- Sponsor
- GlaxoSmithKline · Industry
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About This Trial
This study will evaluate the safety and tolerability of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Able and willing to understand and sign a written informed consent form (ICF) that must be obtained prior to the initiation of study procedures
* Age \>=18 through \<=75 years at enrolment
* History or presence of 2 or more of the 5 components of metabolic syndrome per America…
Contacts