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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04480710
Other study ID # HEPA-CRV431-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 23, 2020
Est. completion date October 30, 2021

Study information

Verified date June 2022
Source Hepion Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431 in presumed NASH F2/F3 subjects. Study will evaluate the safety and tolerability of a once daily 75mg dose and 225mg of CRV431 compared to placebo over 28 days of dosing. Pharmacokinetic parameters of CRV431 and its major metabolites and fraction unbound will also be evaluated. Non-invasive antifibrotic bio-markers will be collected and quantified from presumed NASH F2/F3 subjects dosed with 75mg CRV431 or placebo.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date October 30, 2021
Est. primary completion date June 29, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Key Inclusion Criteria: - 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. Key Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CRV431 75mg
1 x 75mg softgel capsule
Placebo (1 softgel)
1 x placebo softgel capsule
CRV431 225mg
3 x 75mg softgel capsule
Placebo (3 softgels)
3 x placebo softgel capsule

Locations

Country Name City State
Puerto Rico FDI Clinical Research San Juan
United States Aventiv Research Inc. Columbus Ohio
United States Gastrointestinal Specialists of Georgia Marietta Georgia
United States La Salud Research, Inc. Miami Florida
United States Conquest Clinical Research Orange California
United States Progressive Medical Research Port Orange Florida
United States Alliance Clinical Research Poway California
United States Pinnacle Research Group San Antonio Texas
United States Quality Research Inc. San Antonio Texas
United States Covenant Research, LLC. Sarasota Florida

Sponsors (1)

Lead Sponsor Collaborator
Hepion Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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
Primary 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
Primary 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.
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