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

NCT04480710 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2022-07-15

Study results available
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Summary

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

Conditions

  • NASH - Nonalcoholic Steatohepatitis
  • Fibrosis, Liver
  • NAFLD - Nonalcoholic Fatty Liver Disease

Interventions

DRUG

CRV431 75mg

1 x 75mg softgel capsule

DRUG

Placebo (1 softgel)

1 x placebo softgel capsule

DRUG

CRV431 225mg

3 x 75mg softgel capsule

DRUG

Placebo (3 softgels)

3 x placebo softgel capsule

Sponsors & Collaborators

  • Hepion Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Carlos Canizares, R.Ph. · Hepion Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-23
Primary Completion
2021-06-29
Completion
2021-10-30
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04480710 on ClinicalTrials.gov