Trial intelligence / Profile preview

EMOTION: MBK-01 in NASH

NCT05622526Phase 2Not yet recruiting

Sponsor
IDIVAL
Start
Jan 2024
Primary completion
Nov 2025
Modality
Live Biotherapeutic Products
01

Overview

Phase 2, randomised, double-blind trial of MBK-01 in Nonalcoholic steatohepatitis (NASH) (2 arms), sponsored by IDIVAL. Primary endpoints: Proportion of patients with improvement of fat fraction by proton density by MRI and no worsening of activity or fibrosis at 72 weeks and Number of adverse events (AEs), serious AEs, AEs resulting in discontinuation, AEs of special interest, and changes in vital signs and laboratory values at 72 weeks. Planned start Jan 2024; status: not yet recruiting.

02

Drugs

MBK-01
03

Conditions

Nonalcoholic steatohepatitis (NASH)

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