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CRV431

Phase 2

NASH - Nonalcoholic Steatohepatitis | Small Molecules | Metabolic |Hepion Pharmaceuticals, Inc.|Trials Updated: Oct 3, 2024

CRV431 development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Jul 2018

CRV431 target and mechanism

ModalitySmall Molecules

Also known as Rencofilstat

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials4
Total Enrollment205

FDA Designations

No designations recorded

CRV431 clinical trials

CRV431 · 4 trials · 7 indications

Phase 2 2Phase 1 1Early Phase 1 1
NCT05461105A Study to Evaluate the Safety and Efficacy of Rencofilstat in Adult Subjects With NASH F3NASH With Fibrosis
COMPLETED60 Analytics
NCT04480710A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 SubjectsNASH - Nonalcoholic Steatohepatitis
COMPLETED47 Analytics
PHASE2COMPLETED
A Study to Evaluate the Safety and Efficacy of Rencofilstat in Adult Subjects With NASH F3
NASH With Fibrosis
NCT0546110560
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PHASE2COMPLETED
A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects
NASH - Nonalcoholic Steatohepatitis
NCT0448071047
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Study Endpoints

Primary Endpoints

Change from baseline in DSI score of subjects taking rencofilstat (75 mg, 150 mg, 225 mg), determined using HepQuant SHUNT Test, on Day 60, and Day 120.
120 Days

Primary Efficacy Endpoint

The percent of subjects taking rencofilstat (75 mg, 150 mg, 225 mg) that have experienced treatment-emergent adverse events, serious adverse events, adverse events of special interest, physical and laboratory abnormalities.
120 Days

Primary Safety Endpoint

Number of Safety and Tolerability Events of CRV431 Versus Placebo.
Time from informed consent to study day 42.

Number of adverse events, serious adverse events, and clinical laboratory abnormalities.

Tmax, of Once Daily (QD) 75mg and 225mg mg Doses of CRV431 is Presumed Non-alcoholic Steatohepatitis F2/F3 Fibrosis Subjects.
Day 1 and Day 28

The Tmax value is defined as time to reach maximum whole blood concentration. Each value is a median for the cohort along with the standard deviation presented in hours for Day 1 and Day 28.

Cmax, of Once Daily (QD) 75mg and 22mg mg Doses of CRV431 is Presumed Non-alcoholic Steatohepatitis F2/F3 Fibrosis Subjects.
Day 1 and Day 28

The Cmax value is defined as the maximum whole blood concentration presented as ng/mL. Each value is a geometric mean for the cohort along with the standard deviation for Day 1 and Day 28.

AUC 0-last, of Once Daily (QD) 75mg and 225mg mg Doses of CRV431 in Presumed Non-alcoholic Steatohepatitis F2/F3 Fibrosis Subjects.
Timepoints for data collection include 0, 2.0 hours, 4.0 hours, 8 hours on both Day 1 and Day 28.

The AUC 0-last value is defined as the area under the whole blood concentration time curve from time 0 to the time of the last measurable concentration. Each value is a geometric mean for the cohort along with the standard deviation for Day 1 and Day 28.

Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events
56 days
To Determine the Mass Balance Recovery After a Single Oral Dose of [14C]-Rencofilstat
22 Days

Cumulative percentage of total radioactivity recovered after a single oral dose of \[14C\]-rencofilstat.

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort A: rencofilstat 75 mgEXPERIMENTAL1 rencofilstat 75 mg softgel capsule, 75 mg daily dose, QD 120 days
Cohort B: rencofilstat 150 mgEXPERIMENTAL2 rencofilstat 75 mg softgel capsules, 150 mg daily dose, QD 120 days
Cohort C: rencofilstat 225 mgEXPERIMENTAL3 rencofilstat 75 mg softgel capsules, 225 mg daily dose, QD 120 days
CRV431 75mgEXPERIMENTALCRV431, softgel capsule, 75mg, QD, 28 days, fasted conditions
Placebo, 75mgPLACEBO_COMPARATORPlacebo, softgel capsule, QD, 28 days, fasted conditions
CRV431 225mgEXPERIMENTALCRV431, softgel capsule, 225mg, QD, 28 days, fasted conditions
Placebo, 225mgPLACEBO_COMPARATORCRV431, 3 softgel capsules, 225mg, QD, 28 days, fasted conditions
CRV431EXPERIMENTALEither single or multiple doses of varying dose levels
PlaceboPLACEBO_COMPARATOR -
TDFEXPERIMENTAL300 mg TDF
[14C]-RCF 225mgEXPERIMENTAL\[14C\]-rencofilstat, 225mg oral dose, self-micro-emulsifying drug delivery system, single dose

Interventions

NameTypeDescription
rencofilstat, 75 mgDRUG1 softgel capsule
rencofilstat, 150mgDRUG2 softgel capsules
rencofilstat, 225 mgDRUG3 softgel capsules
CRV431 75mgDRUG1 x 75mg softgel capsule
Placebo (1 softgel)DRUG1 x placebo softgel capsule
CRV431 225mgDRUG3 x 75mg softgel capsule
Placebo (3 softgels)DRUG3 x placebo softgel capsule
CRV431DRUGSingle or multiple dose(s) of CRV431
PlaceboDRUGSingle Placebo dose
TDFDRUGSingle or multiple dose(s) of TDF
[14C]-rencofilstat 225mgDRUGradio-labelled 225mg oral dose of rencofilstat
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: 1. Male or female between 18 and 75 years of age (inclusive). 2. BMI above 25.0 kg/m2 3. Biopsy confirmed NASH with histologic liver fibrosis stage 3 as defined by the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) scoring of liver fibrosis based on available ...

Countries:United StatesPuerto RicoUnited Kingdom
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