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NCT05583344 · ClinicalTrials.gov registry record · Phase 2
Phase 2b Study of GSK4532990 in Adults With NASH
A Phase 2 study of Non-alcoholic Fatty Liver Disease, sponsored by GlaxoSmithKline.
- Active
- Registry status
- Phase 2
- Development phase
- 284
- Enrollment target
- 20
- Study locations
NCT05583344: Active Phase 2 study of Non-alcoholic Fatty Liver Disease, sponsored by GlaxoSmithKline.
NCT05583344 is a Phase 2 study of Non-alcoholic Fatty Liver Disease that is active but no longer recruiting, run by GlaxoSmithKline. The registered enrollment target is 284 participants, above the 172-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (65% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05583344, a Phase 2 study of Non-alcoholic Fatty Liver Disease, is active but no longer recruiting, sponsored by GlaxoSmithKline.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 284 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to measure improvements in liver fibrosis and inflammation with GSK4532990 compared with placebo in participants with NASH and advanced fibrosis on biopsy (F3 or F4). The study duration will be up to 76 weeks including the screening period. The treatment duration will be up to 52 weeks.
Primary Outcome
Improvement in histological fibrosis is assessed with Clinical research network (CRN) Scoring. No worsening of NASH is defined as no increase in the NAFLD Activity Score (NAS) for steatosis, ballooning, or inflammation.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG GSK4532990
Study Locations (20)
California
- GSK Investigational Site - Huntington Park
- GSK Investigational Site - La Jolla
- GSK Investigational Site - Orange
- GSK Investigational Site - Poway
- GSK Investigational Site - Rialto
- GSK Investigational Site - Sacramento
- GSK Investigational Site - San Francisco
- GSK Investigational Site - Santa Ana
- GSK Investigational Site - Van Nuys
Florida
- GSK Investigational Site - Bradenton
- GSK Investigational Site - Coral Gables
- GSK Investigational Site - Fort Myers
- GSK Investigational Site - Hallandale
Arizona
- GSK Investigational Site - Chandler
- GSK Investigational Site - Chandler
- GSK Investigational Site - Mesa
Arkansas
- GSK Investigational Site - Jonesboro
- GSK Investigational Site - North Little Rock
Alabama
- GSK Investigational Site - Homewood
Colorado
- GSK Investigational Site - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 284 participants |
| Start Date | 2023-01-02 |
| Est. Completion | 2027-04-05 |
| Phase | Phase 2 |
What the registry record for NCT05583344 still lists
NCT05583344 is an interventional study that assigns participants to a tested intervention. The registered 284 participants enrollment target is mid-sized for trials with a published cap, above the 172-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (65% 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.
NCT05583344 names 20 study sites across 6 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT05583344 about?
NCT05583344 is a clinical study titled "Phase 2b Study of GSK4532990 in Adults With NASH". The purpose of this study is to measure improvements in liver fibrosis and inflammation with GSK4532990 compared with placebo in participants with NASH and advanced fibrosis on biopsy (F3 or F4). The study duration will be up to 76 weeks including the screening period. The treatment duration will be...
What is the current status of trial NCT05583344?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 284 participants. The study started on 2023-01-02. Estimated completion is 2027-04-05.
What conditions does trial NCT05583344 study?
This clinical trial studies the following conditions: Non-alcoholic Fatty Liver Disease.
What interventions are being tested in trial NCT05583344?
The interventions under investigation include: Placebo (DRUG), GSK4532990 (DRUG).
Who is sponsoring clinical trial NCT05583344?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05583344 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05583344's enrollment target sits among peer trials
284 8th of 57 higher than 50 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.
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