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

Study Complete

Official Title

A Phase II Randomized, Double-blind, Placebo-controlled, Proof-of-Concept 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

Healthy volunteers

No

Study drug

Cotadutide, Placebo

Sex

All

Actual Enrollment

54

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 14 Jul 2022
Primary Completion Date: 19 Apr 2024
Study Completion Date: 19 Apr 2024

Study design

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

Verification:

Verified 01 May 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria