Safety and Tolerability Study of Cotadutide in Japanese Obese Subjects With Type 2 Diabetes Melitus

What Was Tested

In this phase 1 trial, researchers set out to test Cotadutide.

This is a Phase 1 study designed to assess the safety and tolerability of MEDI0382 (Cotadutide) in Japanese T2DM patients.

It had two arms (groups): Placebo (placebo comparator) and Cotadutide (experimental).

Placebo administered subcutaneously.

Cotadutide administered subcutaneously.

The registry classes the interventions as drug.

More on the Plan

Approximately 20 subjects will be screened in total and 16 subjects will be randomized to Cotadutide or placebo in a 3:1 ratio.

Those subjects who receive Cotadutide will be titrated up to HCTD.

The study has a 2-week screening period, a run-in period of 9 days and an up to 7-week up-titration treatment period followed by a 3-week treatment extension period (if applicable), followed by a 28-day follow-up period.

Who Took Part

Enrollment: 16 actual participants took part.

It was open to people of any sex aged from 20 years up to 74 years.

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

Examples of who could join: Provision of signed and dated written informed consent prior to any mandatory study specific procedures, sampling, and analyses. Subject must be 20 to 74 years of age at screening. Willing and able to self-inject investigational product for the duration of the study. Individuals who are diagnosed with T2DM and have inadequate glycaemic control with diet and exercise. Individuals whose current condition at enrolment are drug naïve defined as.

The full record lists 12 inclusion and 37 exclusion criteria; among the exclusions: subjects with any of the following results at screening and run-in visit; aspartate transaminase (ast) ≥ 3 × upper limit of normal (uln); alanine transaminase (alt) ≥ 3 × uln.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

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

As a double-blind Cotadutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2020-01-21 with completion listed for 2020-07-08.

It ran at 3 sites in Japan (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Incidence of treatment-emergent adverse events (TEAEs). Incidence of treatment-emergent serious adverse events (TESAEs). Clinically important changes in 12-lead electrocardiogram (ECG).

It also tracked 16 secondary outcomes, for example Maximum observed concentration (Cmax), Time to Cmax (tmax), Trough plasma concentration (Ctrough), Anti-drug antibodies (ADAs) to Cotadutide, Change in average glucose levels (mg/dL) and Change in coefficient of variation.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cotadutide in 16 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.