Trial intelligence / Profile preview

MRG-001 in Alcoholic Hepatitis

NCT06307522Phase 2

Key facts

Status
Not yet recruiting
Start
Sep 2024
Primary completion
Sep 2026
Modality
Small Molecules
Drugs
MRG-001
Conditions
alcoholic hepatitis (AH)
01

Overview

Phase 2, open-label trial of MRG-001 in alcoholic hepatitis (AH) (3 arms), sponsored by MedRegen LLC. Primary endpoint: Assessment of Treatment-Emergent Adverse Events at 28 Days. Planned start Sep 2024; status: not yet recruiting.

02

Design

3 arms
Study design
Non-randomizedOpen-label
  • MRG-001 (0.005 mL/kg)

    Lowest dose

  • MRG-001 (0.007 mL/kg)

    Intermediate dose

  • MRG-001 (0.01 mL/kg)

    High dose

03

Endpoints

Primary

  • Assessment of Treatment-Emergent Adverse Events

Secondary

  • Pharmacokinetic Response

  • Pharmacodynamic Response

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