Cohort C: Rencofilstat 225 mg for Liver Fibrosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Liver Fibrosis+2 MoreRencofilstat - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This is a randomized, double-blind, placebo-controlled, parallel-dosing, multi-center study to evaluate the efficacy and safety of Rencofilstat as evidenced by histopathological improvements in fibrosis in adult NASH subjects with F2 or F3 fibrosis (NASH CRN system). Antifibrotic biomarker activity will be evaluated on an exploratory basis.

Eligible Conditions
  • Non-Alcoholic Fatty Liver Disease
  • Non-Alcoholic Fatty Liver Disease (NAFLD)
  • Liver Fibrosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: dosing period of 1 year with 1 month observation and follow up period

Year 1
Change from baseline in ALT.
Change from baseline in AST.
Change from baseline in Pro-C3, type III collagen neo-epitopes.
Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) OR NASH resolution without worsening of fibrosis.
Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system), regardless of effect on NASH.
Proportion of subjects with improvement in fibrosis by at least 2 stages (NASH CRN system) AND no worsening of NASH.
Proportion of subjects with improvement in fibrosis by at least 2 stages (NASH CRN system), regardless of effect on NASH.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

Cohort C: Rencofilstat 225 mg
1 of 4
Cohort B: Rencofilstat 150 mg
1 of 4
Cohort A: Rencofilstat 75 mg
1 of 4
Cohort D: Placebo
1 of 4

Experimental Treatment

Non-Treatment Group

336 Total Participants · 4 Treatment Groups

Primary Treatment: Cohort C: Rencofilstat 225 mg · Has Placebo Group · Phase 2

Cohort C: Rencofilstat 225 mg
Drug
Experimental Group · 1 Intervention: Rencofilstat · Intervention Types: Drug
Cohort B: Rencofilstat 150 mg
Drug
Experimental Group · 1 Intervention: Rencofilstat · Intervention Types: Drug
Cohort A: Rencofilstat 75 mg
Drug
Experimental Group · 1 Intervention: Rencofilstat · Intervention Types: Drug
Cohort D: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: dosing period of 1 year with 1 month observation and follow up period

Who is running the clinical trial?

Hepion Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
199 Total Patients Enrolled
Stephen Harrison, MDPrincipal InvestigatorPinnacle Clinical Research
7 Previous Clinical Trials
1,511 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects with blood pressure in the range of 160/100 to 160/90 mmHg.
Subjects must be at least 18 years of age and have no history of severe psychiatric or neurological illness.
You are able to give informed consent and communicate effectively with the investigator and study personnel.
A screening biopsy may be substituted for a diagnostic biopsy if the following are met: i
Subjects must have been metabolically stable since the biopsy (no significant weight loss ≥ 7% of body weight, no major deterioration of glycemic control, and no introduction of new or investigational drugs for the treatment of Type 2 Diabetes).
You have histologic liver fibrosis stage 2 or 3 as defined by the NASH CRN scoring of liver fibrosis based on central reading of the Screening biopsy.