NCT04480710

Brief Summary

This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431 in presumed NASH F2/F3 subjects.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2020

Shorter than P25 for phase_2

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 23, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
9 months until next milestone

Results Posted

Study results publicly available

July 15, 2022

Completed
Last Updated

July 15, 2022

Status Verified

June 1, 2022

Enrollment Period

1 year

First QC Date

July 9, 2020

Results QC Date

May 2, 2022

Last Update Submit

July 13, 2022

Conditions

NASH - Nonalcoholic SteatohepatitisFibrosis, LiverNAFLD - Nonalcoholic Fatty Liver Disease

Keywords

Anti-fibrotic

Outcome Measures

Primary Outcomes (4)

  • Number of Safety and Tolerability Events of CRV431 Versus Placebo.

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

    Time from informed consent to study day 42.

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

    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.

    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.

    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.

    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.

    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.

    Timepoints for data collection include 0, 2.0 hours, 4.0 hours, 8 hours on both Day 1 and Day 28.

Study Arms (4)

CRV431 75mg

EXPERIMENTAL

CRV431, softgel capsule, 75mg, QD, 28 days, fasted conditions

Drug: CRV431 75mg

Placebo, 75mg

PLACEBO COMPARATOR

Placebo, softgel capsule, QD, 28 days, fasted conditions

Drug: Placebo (1 softgel)

CRV431 225mg

EXPERIMENTAL

CRV431, softgel capsule, 225mg, QD, 28 days, fasted conditions

Drug: CRV431 225mg

Placebo, 225mg

PLACEBO COMPARATOR

CRV431, 3 softgel capsules, 225mg, QD, 28 days, fasted conditions

Drug: Placebo (3 softgels)

Interventions

CRV431 75mgDRUG

1 x 75mg softgel capsule

CRV431 75mg
Placebo (1 softgel)DRUG

1 x placebo softgel capsule

Placebo, 75mg
CRV431 225mgDRUG

3 x 75mg softgel capsule

CRV431 225mg
Placebo (3 softgels)DRUG

3 x placebo softgel capsule

Placebo, 225mg

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female between 18 and 75 years of age (inclusive).
  • Capable of giving written informed consent and able to effectively communicate with the investigator and study personnel.
  • Presumed F2/F3 NASH to include: AST \>20 IU/L, Pro-C3 \>15.5 ng/mL, enhanced liver fibrosis (ELF) score \>9.8, and FibroScan \>8.5 kPa values.

You may not qualify if:

  • Pregnant or breastfeeding or planning to become pregnant during the study period.
  • Known allergy to CRV431, cyclosporine, or any of their inactive ingredients.
  • Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus antibodies (HIVAb).
  • Well documented causes of chronic liver disease according to standard diagnostic procedures to include any history or presence of decompensated cirrhosis.
  • Subjects with a platelet count \<150,000/mL.
  • Subjects with hemoglobin A1c(HbA1c) \>9.5%.
  • Weight loss of more than 5% within 3 months prior to randomization.
  • Subjects with a blood pressure to include a systolic pressure \>150 or a diastolic pressure \>90.
  • At Screening, an estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 mL (calculated by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] method) and/or a Kidney Disease Improving Global Outcomes (KDIGO) category of \>G2.
  • Subjects with a history of organ transplantation. Corneal transplantation will be allowed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Conquest Clinical Research

Orange, California, 92866, United States

Location

Alliance Clinical Research

Poway, California, 92064, United States

Location

La Salud Research, Inc.

Miami, Florida, 33155, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Covenant Research, LLC.

Sarasota, Florida, 34249, United States

Location

Gastrointestinal Specialists of Georgia

Marietta, Georgia, 30060, United States

Location

Aventiv Research Inc.

Columbus, Ohio, 43213, United States

Location

Quality Research Inc.

San Antonio, Texas, 78209, United States

Location

Pinnacle Research Group

San Antonio, Texas, 78229, United States

Location

FDI Clinical Research

San Juan, 00927, Puerto Rico

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseLiver Cirrhosis

Interventions

CRV-431

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Clinical Operations
Organization
Hepion Pharmaceuticals Inc
jgreytok@hepionpharma.com
732-902-4016

Study Officials

  • Carlos Canizares, R.Ph.

    Hepion Pharmaceuticals, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
placebo-controlled
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, multi-center, single-blind
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2020

First Posted

July 21, 2020

Study Start

June 23, 2020

Primary Completion

June 29, 2021

Study Completion

October 30, 2021

Last Updated

July 15, 2022

Results First Posted

July 15, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

PR(1)US(9)