A Study in Participants with Non-cirrhotic NASH with Fibrosis - COSMOS

Study identifier:D6581C00001

ClinicalTrials.gov identifier:NCT05638737

EudraCT identifier:N/A

CTIS identifier:2022-500594-13-00

Recruiting

Official Title

A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZD4831 in Participants with Noncirrhotic non-alcoholic Steatohepatitis (NASH) with Fibrosis

Medical condition

Non-cirrhotic Non-alcoholic Steatohepatitis with Fibrosis

Phase

Phase 2

Healthy volunteers

No

Study drug

AZD4831

Sex

All

Actual enrollment

90

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 26 Oct 2022
Estimated Primary Completion Date: 01 Jul 2024
Estimated Study Completion Date: 01 Jul 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 May 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria