Pharmacokinetics of Cotadutide in Participants With Hepatic Impairment

What Was Tested

This registered phase 1 trial tested Cotadutide.

It had four arms (groups): Cohort 1 (experimental), Cohort 2 (experimental), Cohort 3 (experimental) and Cohort 4 (experimental).

The registry classes the interventions as combination product.

More on the Plan

This study will consist of four cohorts (Cohort 1, Cohort 2, Cohort 3, and Cohort 4).

Who Took Part

24 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Participant must be ≥ 18 to ≤ 85 years of age at the time of signing the Informed Consent Form (ICF). Body mass index ≥ 18 kg/m2 to \< 40 kg/m2. Capable of giving signed informed consent.

The full record lists 4 inclusion and 24 exclusion criteria; among the exclusions: history of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to cotadutide; prolonged qtcf \> 470 ms or family history of long qt syndrome; PR (PQ) interval shortening \< 120 ms.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Cotadutide study did not mask who received what.

It started in 2022-09-06 with completion listed for 2023-02-27.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Maximum observed plasma (peak) drug concentration [Cmax] (time frame: Day 1 to Day 3). Area under plasma concentration time curve from zero to infinity (AUCinf) (time frame: Day 1 to Day 3). Area under the plasma concentration-curve from time zero to last quantifiable concentration (AUClast) (time frame: Day 1 to Day 3).

It also tracked 2 secondary outcomes, for example Number of participants with Adverse Events (AEs) and Incidence of ADAs (anti-drug antibodies).

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Cotadutide in 24 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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