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

What Was Tested

This registered phase 2 trial tested Cotadutide.

It had four arms (groups): one (experimental), one (placebo comparator), one (experimental) and one (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 54 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Provision of informed consent. Males and female participants ≥ 18 to ≤ 75 years of age (inclusive) at the time of signing the informed consent. NAS (Non-alcoholic Fatty Liver Disease Activity Score) ≥ 4 with a score of ≥ 1 for each component: steatosis, lobular inflammation, and ballooning. Presence of fibrosis stage F2 or F3.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: chronic liver disease of other etiologies; history of malignant neoplasms within 5 years prior to screening, except for adequately treated basal cell, squamous cell skin cancer, or any in situ carcinoma; severe allergy/hypersensitivity to any of the proposed study treatments or excipients.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Cotadutide group and the comparison group should start out alike.

The Cotadutide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Cotadutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2022-07-14 with completion listed for 2024-04-19.

It ran at 115 sites in United States (29), Japan (17), United Kingdom (8), Italy (7), Israel (6) and South Korea (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Adverse Events (AEs). Number of Participants With Abnormal Vital Signs. Number of Participants With Abnormal Laboratory Assessments.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cotadutide in 54 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Cotadutide compound page, all human trials.