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FXR Agonist

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CS0159 in Subjects With NASH

Phase 2
Waitlist Available
Research Sponsored by Cascade Pharmaceuticals, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6, week 12

Summary

This trial is testing a new drug called CS0159 to see if it can help people with a liver disease called NASH. The study will check if the drug is safe and if it can improve liver health by reducing inflammation and fat in the liver.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6, week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6, week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse events
Magnetic Resonance Imaging
Secondary study objectives
AUC
Cmax
Pharmacodynamics (PD)
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 2mg CS0159Experimental Treatment1 Intervention
One tablet daily for 12 weeks
Group II: 1.4mg CS0159Experimental Treatment1 Intervention
One tablet daily for 12 weeks
Group III: PLACEBOPlacebo Group1 Intervention
One tablet daily for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CS0159 (Linafexor)
2023
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

Cascade Pharmaceuticals, IncLead Sponsor
7 Previous Clinical Trials
406 Total Patients Enrolled
Laboratory Corporation of AmericaIndustry Sponsor
31 Previous Clinical Trials
18,604 Total Patients Enrolled
Rong DengStudy DirectorCascade Pharmaceuticals, Inc
2 Previous Clinical Trials
125 Total Patients Enrolled

Media Library

CS0159 (Linafexor) (FXR Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05591079 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: 2mg CS0159, 1.4mg CS0159, PLACEBO
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: CS0159 (Linafexor) Highlights & Side Effects. Trial Name: NCT05591079 — Phase 2
CS0159 (Linafexor) (FXR Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05591079 — Phase 2
~35 spots leftby Dec 2025
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