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NCT07221227 · ClinicalTrials.gov registry record · Phase 3
A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH
A Phase 3 study of Non-alcoholic Fatty Liver Disease, sponsored by GlaxoSmithKline.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,200
- Enrollment target
- 1
- Study location
NCT07221227: Recruiting Phase 3 study of Non-alcoholic Fatty Liver Disease, sponsored by GlaxoSmithKline.
NCT07221227 is a Phase 3 study of Non-alcoholic Fatty Liver Disease that is actively recruiting participants, run by GlaxoSmithKline. The registered enrollment target is 1,200 participants, above the 156-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (669% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07221227, a Phase 3 study of Non-alcoholic Fatty Liver Disease, is actively recruiting participants, sponsored by GlaxoSmithKline.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,200 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and biopsy-confirmed F2- or F3-stage fibrosis.
Primary Outcome
Proportion of participants experiencing improvement in fibrosis of greater than or equal to (\>=) 1 stage by MASH clinical research network (CRN) fibrosis scores and no worsening of steatohepatitis (defined as no increase in nonalcoholic fatty liver disease activity score \[NAS\] for ballooning, inflammation, or steatosis) at 52 weeks will be assessed. MASH CRN fibrosis score ranges from 0 to 4, higher score indicates greater severity. NAS score ranges from 0 to 8, higher score indicates worse d
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Efimosfermin alfa
Study Locations (1)
Florida
- GSK Investigational Site - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,200 participants |
| Start Date | 2025-10-23 |
| Est. Completion | 2031-12-12 |
| Phase | Phase 3 |
What NCT07221227 shows while recruiting
NCT07221227 is an interventional study that assigns participants to a tested intervention. Its 1,200 participants enrollment target places it among the larger protocols in the corpus, above the 156-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (669% higher).
The record links to 1 condition, with Non-alcoholic Fatty Liver Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07221227 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT07221227 about?
NCT07221227 is a clinical study titled "A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH". The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and biopsy-confirmed F2- or F3-stage fibrosis.
What is the current status of trial NCT07221227?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,200 participants. The study started on 2025-10-23. Estimated completion is 2031-12-12.
What conditions does trial NCT07221227 study?
This clinical trial studies the following conditions: Non-alcoholic Fatty Liver Disease.
What interventions are being tested in trial NCT07221227?
The interventions under investigation include: Placebo (DRUG), Efimosfermin alfa (DRUG).
Who is sponsoring clinical trial NCT07221227?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07221227 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07221227's enrollment target sits among peer trials
1,200 3rd of 57 higher than 55 of 57 other Non-alcoholic Fatty Liver Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-alcoholic Fatty Liver Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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