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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
Awards & highlights

Study Summary

This trial tests a new drug to treat NASH, a liver disease, to see if it's safe and effective.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse events
Magnetic Resonance Imaging
Secondary outcome measures
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
5 Previous Clinical Trials
246 Total Patients Enrolled
Laboratory Corporation of AmericaIndustry Sponsor
27 Previous Clinical Trials
9,786 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 30 and above being taken into consideration for this research trial?

"The minimum age requirement for this clinical trial is 18 years old, and the maximum age limit is 75."

Answered by AI

Is the participant recruitment phase of this trial still ongoing?

"According to clinicaltrials.gov, this medical trial is currently open and actively recruiting patients; the study was initially published on February 10th 2023 with edits made as recently as February 18th of the same year."

Answered by AI

How many volunteers have enrolled in this experiment?

"Affirmative, the trial is actively looking for participants. The study was initially posted on February 10th 2023 and recently updated on 18th of the same month. Currently, they are searching to recruit 100 patients from 1 site."

Answered by AI

How hazardous would be the effects of ingesting 1.4mg CS0159?

"Our assessment of 1.4mg CS0159 was a 2 on our scale from 1 to 3, as this is in its Phase 2 trial and has some evidence for safety but not yet efficacy."

Answered by AI

What are the core objectives of this research initiative?

"Laboratory Corporation of America, the study sponsor, has reported that over a 12-week period they will be primarily measuring Adverse events. Additionally they will be assessing secondary metrics such as tmax (maximum plasma concentration time span), t1/2 (half-life of drug) and AUC (accumulation ratio)."

Answered by AI

Does my profile meet the criteria for this trial's enrollment?

"This medical trial is looking for approximately 100 participants aged between 18 and 75 who have been diagnosed with non-alcoholic fatty liver disease (NAFLD). Furthermore, they must meet the following criteria: display symptoms of NASH., possess evidence of metabolic syndrome, unless their condition has already been confirmed by biopsy results; BMI >25 kg/m2 or higher (or alternatively 23kg/m2 if they are an Asian American); and steady use of antidiabetic medication, weight reduction treatments, or lipid modifiers over a 12 week period prior to randomization."

Answered by AI
~46 spots leftby Apr 2025