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rencofilstat

Phase 2

NASH With Fibrosis | Small Molecules | Metabolic |Hepion Pharmaceuticals, Inc.|Trials Updated: Oct 3, 2024

rencofilstat development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Jun 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment66

FDA Designations

No designations recorded

rencofilstat clinical trials

rencofilstat · 2 trials · 1 indication

Phase 2 1Early Phase 1 1
NCT05461105A Study to Evaluate the Safety and Efficacy of Rencofilstat in Adult Subjects With NASH F3NASH With Fibrosis
COMPLETED60 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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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

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
[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
[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 StatesUnited Kingdom
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Competitive Landscape -Cystic Fibrosis 20 trials (matched to "NASH With Fibrosis")

Top 6 of 7 competitors

CompanyTickerTrialsLead PhaseDrugs
Vertex Pharmaceuticals IncorporatedVRTX8PHASE3Alyftrek, Trikafta, Ivacaftor, VX-581, VX-272
BiomX Inc.PHGE1PHASE2BX004
4D Molecular Therapeutics, Inc.FDMT1PHASE24D-710
Arcturus Therapeutics Holdings, Inc.ARCT1PHASE2ARCT-032
Roivant Sciences Ltd.ROIV1PHASE2SP-101
Krystal Biotech, Inc.KRYS1PHASE1KB407
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