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

Part of paid clinical trials in Gardena, California.

Sponsor
Cascade Pharmaceuticals, Inc
Study ID
NCT05591079
Phase
PHASE2
Status
Completed

Conditions

  • Nonalcoholic Steatohepatitis (NASH)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • CS0159 (Linafexor) — DRUG
    Oral QD

Study Details

A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of CS0159 in subjects with Non-Alcoholic Steatohepatitis (NASH)

Key Dates

First listed
Oct 24, 2022
Start date
Feb 10, 2023
Status verified
Jul 2023
Primary completion
Nov 9, 2023
Completion
Nov 9, 2023

Study Design

Enrollment
99 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1.4mg CS0159
    One tablet daily for 12 weeks
  • Experimental: 2mg CS0159
    One tablet daily for 12 weeks
  • Placebo Comparator: PLACEBO
    One tablet daily for 12 weeks

Primary Outcome Measure

MRI-PDFF [ Time Frame: Week 12 ]

Locations (17)

FacilityCityStateZIPSite coordinators
National Research Institute - GardenaGardenaCalifornia90247-3586-
Velocity Clinical Research, Huntington ParkHuntington ParkCalifornia90255-2959-
Velocity Clinical Research - Panorama CityPanorama CityCalifornia91402-3022-
Velocity Clinical Research - Santa AnaSanta AnaCalifornia92704-
Ocala GI ResearchLady LakeFlorida32159-
Florida Research InstituteLakewoodFlorida34211-4930-
San Marcus Research Clinic, Inc - MiamiMiamiFlorida33014-5602-
Floridian Clinical Research, LLC - Miami LakesMiami LakesFlorida33016-1518-
Gastroenterology Associates of OcalaOcalaFlorida34471-
Oracle Clinical ResearchCollege ParkGeorgia30349-
Metropolitan Gastroenterology Associates - Westbank Office and EndoscopyMarreroLouisiana70072-
Raja M. Din MD, PLLC - Gastroenterology & HepatologyGreenbeltMaryland20770-6702-
Lucas ResearchMorehead CityNorth Carolina28557-
Texas Liver Institute (TLI) - AustinAustinTexas78757-7571-
Pioneer Research Solutions Inc - Houston - Stancliff RdHoustonTexas77099-4307-
Clinical Trials of Texas, LLCSan AntonioTexas78229-
The Texas Liver Institute, Inc.San AntonioTexas78215-

Find similar trials in Gardena, CA

By research site
National Research Institute - Gardena· Gardena, CAVelocity Clinical Research, Huntington Park· Huntington Park, CAVelocity Clinical Research - Panorama City· Panorama City, CAVelocity Clinical Research - Santa Ana· Santa Ana, CAOcala GI Research· Lady Lake, FLFlorida Research Institute· Lakewood, FL

Related Studies