A Randomised, Open-Label Study to Evaluate the Relative and Absolute Bioavailability of Cotadutide in Healthy Subjects

What Was Tested

The trial (phase 1) is built around Cotadutide.

This healthy volunteer study will try to identify how two different concentrations of cotadutide are taken up by the body when dosed under the skin (subcutaneous injection).

The study will also try to identify the absolute bioavailability of cotadutide (amount taken up by the body when dosed under the skin compared to an injection directly into the vein (intravenous)).

It had 1 arm (groups): Cotadutide solution for injection (experimental).

Period 1, subcutaneous injection of cotadutide solution Period 2, subcutaneous injection of cotadutide solution Period 3, subcutaneous injection of cotadutide solution.

The registry classes the interventions as drug.

More on the Plan

NASH is a common liver disease characteristic of a damaged liver that may no longer work properly.

T2DM is a condition that causes sugar (glucose) levels in the blood to become too high which can damage the blood vessels within the kidney leading to chronic kidney disease and also causing problems with eyes, heart and nerves.

The study will also assess the safety and tolerability of cotadutide.

Who Took Part

Enrollment: 10 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Provision of signed and dated, written informed consent prior to any study specific procedures. Healthy males or non-pregnant, non-lactating healthy females aged 18 to 55 years at the time of signing informed consent. Have a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive. Must be willing and able to communicate and participate in the whole study. Must agree to adhere to the contraception requirements defined in Section 9.4.

The full record lists 7 inclusion and 30 exclusion criteria; among the exclusions: history or presence of any disease or condition known to interfere with absorption, distribution, metabolism, or excretion of drugs; A personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2; thyroid c-cell hyperplasia (calcitonin level \> 50 ng/l) or medullary thyroid carcinoma at screening.

How the Study Was Run

The set-up was randomized, single-group and open-label.

Random assignment meant chance, not the researchers, decided who got Cotadutide and who got the comparison, which limits bias.

Everyone knew when Cotadutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2022-03-28 with completion listed for 2022-09-12.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Absolute bioavailability of the high and the low concentration cotadutide SC formulations. Maximum observed concentration (cmax). Relative bioavailability of a high concentration cotadutide SC formulation in comparison to low concentration formulation, in the fasted state.

It also tracked 13 secondary outcomes, for example Number of adverse events (AEs) experienced by subjects and Evaluate immunogenicity for cotadutide administered as low and high concentration SC formulations and an IV formulation.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cotadutide in 10 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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