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FXR Agonist
2mg CS0159 for Non-alcoholic Fatty Liver Disease
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 6, week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6, week 12
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken medications that activate the farnesoid X receptor (FXR) within the past 3 months.You have been diagnosed with a condition called NASH.You have metabolic syndrome, except if you have been diagnosed with NASH through a liver biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: 2mg CS0159
- Group 2: 1.4mg CS0159
- Group 3: PLACEBO
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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