Chinese Multiple Dose Escalation (MDE) High Dose Study

What Was Tested

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

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

Placebo: Placebo subcutaneous injection.

The registry classes the interventions as drug and other.

More on the Plan

This study will enroll subjects aged 18 to 74 years with a body mass index (BMI) ≥ 25 and ≤ 35 kg/m2.

Total 16 Chinese subjects will be randomized to cotadutide or placebo in a 3:1 ratio (cotadutide \[n=12\] and placebo \[n=4\]) at multicentre in China mainland.

Who Took Part

The registry lists 16 actual participants took part.

It was open to people of any sex aged from 18 years up to 74 years.

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

Examples of who could join: Subjects aged 18 to 74 years. Provision of signed and dated written informed consent prior to any study specific procedures. BMI between 25 and 35 kg/m2. Willing and able to self-inject investigational product.

The full record lists 7 inclusion and 36 exclusion criteria; among the exclusions: concurrent participation in another randomization study of any kind; repeat randomization is prohibited; any subject who has received any of the following medications within the specified timeframe prior to the start of the study; herbal preparations for control of body weight or appetite.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Cotadutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Blinding on both sides kept the participants and researchers unaware of who received Cotadutide.

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

It started in 2022-02-25 with completion listed for 2022-12-12.

It ran at 2 sites in China (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Incidence of treatment-emergent adverse events (TEAEs). Incidence of treatment-emergent serious adverse events (TESAEs). Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs.

It also tracked 13 secondary outcomes, for example Anti-drug antibodies (ADAs) to Cotadutide, Change in daily average glucose levels, Change in 7-day average glucose levels, Change in estimated hemoglobin A1c (HbA1c), Change in fasting plasma glucose (mg/dL) and Change in HbA1c.

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.