A study to evaluate AZD2693 in participants who are carriers of the PNPLA3 148M Risk Allele with non-cirrhotic non-alcoholic steatohepatitis with fibrosis - FORTUNA

Study identifier:D7830C00004

ClinicalTrials.gov identifier:NCT05809934

EudraCT identifier:2022-001629-65

CTIS identifier:N/A

Recruitment Complete

Official Title

A Randomised, Double-blind, Placebo-controlled, Multi-centre Phase 2b Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) with Fibrosis who are carriers of the PNPLA3 rs738409 148M Risk Allele

Medical condition

Nonalcoholic Steatohepatitis

Phase

Phase 2

Healthy volunteers

No

Study drug

AZD2693

Sex

All

Actual Enrollment

220

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 15 Mar 2023
Estimated Primary Completion Date: 03 Oct 2025
Estimated Study Completion Date: 03 Oct 2025

Study design

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

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

AstraZeneca K.K

Inclusion and exclusion criteria