Influence of JY09 on Pharmacokinetics of Metformin , Rosuvastatin , and Digoxin and the QT Interval Study in Overweight Chinese Subjects

What Was Tested

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

This trial is conducted in china.

It had 1 arm (groups): Exendin-4 Fc fusion protein (JY09) injection (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 28 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: Body weight: men ≥ 50.0 kg, women ≥ 45.0 kg, body mass index (BMI) ≥ 24.0 kg/m2 and ≤ 28.0 kg/m2 , BMI = weight (kg)/height (m2 ). Understand the content of the informed consent form, agree to participate in this trial and voluntarily sign the consent form.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: A clear history of central nervous system, cardiovascular system, renal, hepatic, pulmonary, metabolic, and musculoskeletal disorders or other notable diseases; have disorders of electrolyte metabolism such as hyperkalemia, hypokalemia, hypomagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia; those who have participated in other clinical trials as a subject within 3 months prior to screening.

How the Study Was Run

It was run as a non-randomized, crossover and open-label study.

In the crossover set-up each of the participants took both Exenatide and the comparison in turn, acting as their own control.

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

It started in 2023-10-19 with completion listed for 2024-04-15.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The Metformin Peak Concentration (Cmax ). Area under the Metformin blood concentration-time curve. The Rosuvastatin Peak Concentration (Cmax ).

It also tracked 11 secondary outcomes, for example Safety endpoint-Adverse events, Vital signs-Blood pressure, Vital signs-Pulse, Vital signs-Respiration, Physical examination and Laboratory tests-Routine blood.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Exenatide in 28 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 Exenatide compound page, all human trials.