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CS0159

Phase 2

Nonalcoholic Steatohepatitis (NASH) | Small molecule | Metabolic |Labcorp Holdings Inc.|Last Updated: Nov 21, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment99

FDA Designations

No designations recorded

Clinical trial landscape

CS0159 · 1 trial · 1 indication

Phase 2 1
NCT05591079A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CS0159 in Subjects With NASHNonalcoholic Steatohepatitis (NASH)
COMPLETED99 Analytics
PHASE2COMPLETED
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CS0159 in Subjects With NASH
Nonalcoholic Steatohepatitis (NASH)
NCT0559107999
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Study Endpoints

Primary Endpoints

MRI-PDFF
Week 12

To assess the changes in liver steatosis through magnetic resonance imaging (MRI) proton density fat fraction (PDFF) from baseline to Week 12

Adverse events
Week 12

To evaluate the safety and tolerability of CS0159 in patients with NASH treated over 12 weeks

Secondary Endpoints

Cmax
week 6, week 12
tmax
week 6, week 12
t1/2
week 6, week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1.4mg CS0159EXPERIMENTALOne tablet daily for 12 weeks
2mg CS0159EXPERIMENTALOne tablet daily for 12 weeks
PLACEBOPLACEBO_COMPARATOROne tablet daily for 12 weeks

Interventions

NameTypeDescription
CS0159 (Linafexor)DRUGOral QD
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: 1. Patients who meet the diagnosis of NASH. 2. Evidence of metabolic syndrome, except for those patients with biopsy-proven NASH. 3. Body mass index (BMI) \>25 kg/m2, NOTE: for Asian-Americans BMI \>23 kg/m2. 4. Stable use of other antidiabetic, weight loss, or lipid-modifying m...

Countries:United States
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