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

Registration

Registration

NCT05364931

Acronym

PROXYMO-ADV

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE2

Masking

QUADRUPLE

Status

COMPLETED

Enrollment

54

Start

2022-07-14

Primary completion

2024-04-19

Lead sponsor

AstraZeneca

Conditions

Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis

Interventions

DRUG:Cotadutide; DRUG:Placebo

Results posted

TRUE

Individual participant data sharing

YES

Secondary identifiers

EUDRACT_NUMBER:2021-005484-53

Registered primary outcomes

• Number of Participants With Adverse Events (AEs). [First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.]
• Number of Participants With Abnormal Vital Signs. [First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.]
• Number of Participants With Abnormal Laboratory Assessments [First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.]
• Number of Participants With Treatment Emergent Abnormality in 12-lead Electrocardiogram (ECG). [First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.]
• Number of Treatment-induced Anti-Drug Antibody (ADA) Participants [First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.]
• Titer of Treatment-induced Anti-Drug Antibody (ADA) [From first dose on Day 1 until the follow-up period, 28 days post last dose (from randomization up to approximately 52 weeks).]