A Single-Center, Open-Label, Single Ascending Dose Study of Exenatide Circular RNA-Lipid Nanoparticle Injection (CR059) in Chinese Subjects With Type 2 Diabetes Mellitus

What Was Tested

The trial (early phase 1) is built around Exenatide.

It had 1 arm (groups): Exenatide Circular RNA-Lipid Nanoparticle Injection（CR059） (experimental).

The registry classes the interventions as drug.

More on the Plan

Each cohort plans to enroll 2-3 T2DM subjects.

Who Took Part

9 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Chinese male or female， 18≤age≤-65 years . 18.5 kg/m²≤Body Mass Index (BMI) ≤40.0 kg/m² at screening and enrollment. Able to understand and willing to sign the informed consent form, and fully understand the trial content, procedures, and potential adverse reactions. Able to complete the trial according to the protocol requirements.

The full record lists 7 inclusion and 37 exclusion criteria; among the exclusions: diagnosis of type 1 diabetes, diabetes due to pancreatic injury, or specific types of diabetes due to other diseases (e.g., acromegaly or cushing's syndrome); history of acute diabetic complications, such as ketoacidosis or hyperosmolar coma, within 6 months before screening; history or presence of cushing's syndrome, polycystic ovary syndrome, or other hereditary endocrine diseases, or obesity secondary to factors such as hormones.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Exenatide 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 2026-01-20 with completion listed for 2026-08-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Incidence of Treatment-Emergent Adverse Events (TEAEs).

It also tracked 12 secondary outcomes, for example Anti-Drug Antibodies and Anti-Drug Antibodies.

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Exenatide in 9 people.

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

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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