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NCT05591079 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CS0159 in Subjects With NASH
A Phase 2 study of Non-alcoholic Steatohepatitis (NASH), sponsored by Cascade Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 99
- Enrollment target
- 17
- Study locations
NCT05591079: Completed Phase 2 study of Non-alcoholic Steatohepatitis (NASH), sponsored by Cascade Pharmaceuticals.
NCT05591079 is a Phase 2 study of Non-alcoholic Steatohepatitis (NASH) that has completed, run by Cascade Pharmaceuticals. The registered enrollment target is 99 participants, below the 190-participant average among 16 other Non-alcoholic Steatohepatitis (NASH) trials with a reported enrollment target (48% lower). The trial reports 17 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05591079, a Phase 2 study of Non-alcoholic Steatohepatitis (NASH), has completed, sponsored by Cascade Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 99 participants
- Enrollment target
- 17
- Study locations
Study Summary
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of CS0159 in subjects with Non-Alcoholic Steatohepatitis (NASH)
Primary Outcome
To assess the changes in liver steatosis through magnetic resonance imaging (MRI) proton density fat fraction (PDFF) from baseline to Week 12
Conditions Studied
Interventions
- DRUG CS0159 (Linafexor)
Study Locations (17)
Florida
- Ocala GI Research - Lady Lake
- Florida Research Institute - Lakewood
- San Marcus Research Clinic, Inc - Miami - Miami
- Floridian Clinical Research, LLC - Miami Lakes - Miami Lakes
- Gastroenterology Associates of Ocala - Ocala
California
- National Research Institute - Gardena - Gardena
- Velocity Clinical Research, Huntington Park - Huntington Park
- Velocity Clinical Research - Panorama City - Panorama City
- Velocity Clinical Research - Santa Ana - Santa Ana
Texas
- Texas Liver Institute (TLI) - Austin - Austin
- Pioneer Research Solutions Inc - Houston - Stancliff Rd - Houston
- The Texas Liver Institute, Inc. - San Antonio
- Clinical Trials of Texas, LLC - San Antonio
Georgia
- Oracle Clinical Research - College Park
Louisiana
- Metropolitan Gastroenterology Associates - Westbank Office and Endoscopy - Marrero
Maryland
- Raja M. Din MD, PLLC - Gastroenterology & Hepatology - Greenbelt
North Carolina
- Lucas Research - Morehead City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2023-02-10 |
| Est. Completion | 2023-11-09 |
| Phase | Phase 2 |
What the finished NCT05591079 record still lists
NCT05591079 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 190-participant average among 16 other Non-alcoholic Steatohepatitis (NASH) trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Non-alcoholic Steatohepatitis (NASH) appearing as the primary indexed condition, and to 1 intervention - of which CS0159 (Linafexor) is the first listed.
NCT05591079 lists 17 locations in 7 states (Florida, California, Texas).
Frequently Asked Questions
What is clinical trial NCT05591079 about?
NCT05591079 is a clinical study titled "A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CS0159 in Subjects With NASH". A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of CS0159 in subjects with Non-Alcoholic Steatohepatitis (NASH)
What is the current status of trial NCT05591079?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2023-02-10. Estimated completion is 2023-11-09.
What conditions does trial NCT05591079 study?
This clinical trial studies the following conditions: Non-alcoholic Steatohepatitis (NASH).
What interventions are being tested in trial NCT05591079?
The interventions under investigation include: CS0159 (Linafexor) (DRUG).
Who is sponsoring clinical trial NCT05591079?
This trial is sponsored by Cascade Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05591079 being conducted?
This trial has 17 study locations across California, Florida, Georgia, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05591079's enrollment target sits among peer trials
99 11th of 16 higher than 6 of 16 other Non-alcoholic Steatohepatitis (NASH) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-alcoholic Steatohepatitis (NASH) 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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