A study to evaluate the safety and efficacy of cotadutide given by subcutaneous injection in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis. - PROXYMO-ADV

Study identifier:D5671C00006

ClinicalTrials.gov identifier:NCT05364931

EudraCT identifier:2021-005484-53

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase IIb/III Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Cotadutide in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis with Fibrosis

Medical condition

Non-cirrhotic Non-alcoholic Steatohepatitis with Fibrosis

Phase

Phase 2/3

Healthy volunteers

No

Study drug

Cotadutide, Cotadutide, Placebo, Placebo

Sex

All

Actual enrollment

54

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 14 Jul 2022
Estimated Primary Completion Date: 24 Apr 2024
Estimated Study Completion Date: 24 Apr 2024

Study design

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

Verification:

Verified 01 Apr 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria