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NCT04971785 · ClinicalTrials.gov registry record · Phase 2
Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
A Phase 2 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 457
- Enrollment target
NCT04971785: Completed Phase 2 study, sponsored by Gilead Sciences.
NCT04971785 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 457 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (244% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04971785, a Phase 2 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 457 participants
- Enrollment target
Study Summary
The goal of this clinical study is to understand whether the study drugs, semaglutide (SEMA) with the fixed-dose combination (FDC) of cilofexor/firsocostat (CILO/FIR), cause fibrosis improvement and Nonalcoholic Steatohepatitis (NASH) resolution in participants with cirrhosis due to NASH.
Primary Outcome
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH clinical research network (CRN) classification. Worsening of NASH was defined as ≥ 1-point increase from baseline in hepatocellular ballooning or lobular inflammation. Clopper-Pearson method was used in outcome measure analysis in each arm. Percentages were rounded-off.
Interventions
- DRUG Semaglutide (SEMA)
- DRUG Cilofexor (CILO)/Firsocostat (FIR)
- DRUG PTM SEMA
- DRUG PTM CILO/FIR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 457 participants |
| Start Date | 2021-08-09 |
| Est. Completion | 2024-12-09 |
| Phase | Phase 2 |
What the finished NCT04971785 record still lists
NCT04971785 is an interventional study that assigns participants to a tested intervention. The registered 457 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (244% higher).
The record links to 0 conditions, and to 4 interventions - of which Semaglutide (SEMA) is the first listed.
NCT04971785 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04971785 about?
NCT04971785 is a clinical study titled "Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)". The goal of this clinical study is to understand whether the study drugs, semaglutide (SEMA) with the fixed-dose combination (FDC) of cilofexor/firsocostat (CILO/FIR), cause fibrosis improvement and Nonalcoholic Steatohepatitis (NASH) resolution in participants with cirrhosis due to NASH.
What is the current status of trial NCT04971785?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 457 participants. The study started on 2021-08-09. Estimated completion is 2024-12-09.
What interventions are being tested in trial NCT04971785?
The interventions under investigation include: Semaglutide (SEMA) (DRUG), Cilofexor (CILO)/Firsocostat (FIR) (DRUG), PTM SEMA (DRUG), PTM CILO/FIR (DRUG).
Who is sponsoring clinical trial NCT04971785?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04971785's enrollment target sits among peer trials
457 84th of 2000 higher than 1,917 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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