A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects

STATUS

Recruiting
participants needed

18
sponsor

Hepion Pharmaceuticals, Inc.

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Updated on 19 February 2024

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fibrosis

hepatic fibrosis

fatty liver

fibroscan

vcte

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 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.

Details

Condition	Cirrhosis, NASH - Nonalcoholic Steatohepatitis, NAFLD - Nonalcoholic Fatty Liver Disease
Age	18years - 75years
Treatment	Placebo, CRV431
Clinical Study Identifier	NCT04480710
Sponsor	Hepion Pharmaceuticals, Inc.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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
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

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A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects