A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Placebo in T2DM Patients

What Was Tested

The trial (phase 3) is built around Exenatide.

It had three arms (groups): one (experimental), one (experimental) and one (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 270 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Male or female subjects ≥18 years of age and ≤75 years of age at the time of signing the informed consent form. Those who received dietary and exercise interventions for ≥8 weeks prior to screening and who had not received any antidiabetic medications in the 8 weeks prior to screening. Body mass index (BMI) ≥18.5 kg/m2 and ≤35.0 kg/m2 at screening and before randomization (V3). Able to understand and willing to sign a written informed consent form (ICF) and comply with the study protocol.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: people diagnosed with type 1 diabetes or other types of diabetes; acute complications of diabetes, such as diabetic ketoacidosis or hyperglycemic hyperosmolar state, within 6 months prior to screening or prior to randomization; those with any of the following abnormalities on serologic testing at screening:.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

The Exenatide group and the comparison group ran side by side rather than switching.

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

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

It started in 2024-07-10 with completion listed for 2026-05-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: HbA1c (time frame: Baseline, Week 26).

It also tracked 7 secondary outcomes, for example HbA1c, fasting plasma glucose (FPG), fasting insulin, Homeostatic Model Assessment of Insulin Resistance(HOMA-IR), Health Survey Short Form (SF-36) and blood pressure.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 270 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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