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

NCT07347080 · Recruiting

Last updated 2026-05-28

This clinical trial tests the safety of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection (CR059) in adults with type 2 diabetes mellitus in China.

Status Recruiting Currently enrolling participants.

Phase Early Phase 1 First exploratory testing in people.

Type Interventional (clinical trial)

Design open-label (no blinding) treatment study

Participants 9 people Planned (estimated).

Who can join Ages 18–65 · all sexes

Timeline Started 2026-01 · est. completion 2026-08

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT07347080 ↗

Description as written by the study sponsor.

Primary Objectives: •To evaluate the safety and tolerability of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（CR059）in Chinese subjects with T2DM. Secondary Objectives: * To characterize the pharmacokinetic (PK) profile of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（CR059） in Chinese subjects with T2DM; * To characterize the pharmacodynamic (PD) profile of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059） in Chinese subjects with T2DM; * To evaluate the immunogenicity of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059） in Chinese subjects with T2DM; Participants : Diagnosed with T2DM for at least 3 months but less than 5 years, according to the Chinese Diabetes Society's diagnostic criteria

Treatments tested

Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059）） Drug

use one dose per person

Main thing measured	Incidence of Treatment-Emergent Adverse Events (TEAEs)
Sponsor	The First Affiliated Hospital of Henan University of Science and Technology
Conditions studied	T2DM
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07347080 ↗