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 | Not Yet Recruiting Early Phase 1

• 1 other identifier: CR059101
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

T2DM

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  Adverse events (AEs) / Serious adverse events (SAEs) will be collected via: Laboratory tests (including complete blood count, blood biochemistry, glucagon, lipase, amylase, urinalysis, coagulation function, high-sensitivity C-reactive protein, inflammatory factors); Vital signs (blood pressure, pulse rate, body temperature, respiration); Physical examinations (including skin, mucous membranes, lymph nodes, head and neck, chest, abdomen, spine and extremities, and musculoskeletal tissues); 12-lead electrocardiogram (12-lead ECG, including PR interval, QRS duration, QTcF interval); Abnormalities observed by the investigator; Subject-reported complaints.

  From the first dosing (Day 1 ) of study drug until completion of the post treatment follow-up visit(Day 36)

Secondary Outcomes (12)

• Pharmacokinetic

  From the first dose (Day 1 ) of study drug until Day 36

• Pharmacokinetic

  From the first dose (Day 1 ) of study drug until Day 36

• Pharmacokinetic

  From the first dose (Day 1 ) of study drug until Day 36

• Pharmacokinetic

  From the first dose (Day 1 ) of study drug until Day 36

• Pharmacokinetic

  From the first dose (Day 1 ) of study drug until Day 36

Study Arms (1)

Exenatide Circular RNA-Lipid Nanoparticle Injection（CR059）

EXPERIMENTAL

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

Interventions

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

use one dose per person

Exenatide Circular RNA-Lipid Nanoparticle Injection（CR059）

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese male or female， 18≤age≤-65 years .
• Diagnosed with T2DM for at least 3 months but less than 5 years, according to the Chinese Diabetes Society's "Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2024 Edition)" diagnostic criteria.
• Patients who have failed treatment with diet and exercise alone, or metformin monotherapy, or a stable regimen for 12 weeks of metformin (dose ≥1500 mg/day or maximum tolerated dose ≥1000 mg/day) combined with one of the following oral antidiabetic drugs (or their fixed-dose combinations): sulfonylureas, glinides, alpha-glucosidase inhibitors, SGLT2 inhibitors, or thiazolidinediones (at ≥1/2 the maximum approved dose, or the recommended minimum maintenance dose for SGLT2 inhibitors e.g., empagliflozin 10mg, canagliflozin 100mg). Fasting Plasma Glucose (FPG) must be \<13.0 mmol/L, and 7.5%≤HbA1c ≤ 10.0%.
• kg/m²≤Body Mass Index (BMI) ≤40.0 kg/m² at screening and enrollment
• Subjects have no pregnancy plan from screening until 3 months after the last dose and are willing to use at least one effective method of contraception during the entire trial period until 3 months after the last dose.
• 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.

You may not qualify if:

• 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.
• Presence of severe chronic diabetic complications (e.g., proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot, etc.) within 6 months before screening, deemed by the investigator as unsuitable for participation.
• Allergic constitution (allergy to ≥2 types of drugs or foods) or keloid tendency, or clear history of drug allergy, or investigator suspects potential allergy to the investigational product or its components or similar drugs.
• Fasting plasma glucose \<3.9 mmol/L at screening or before enrollment, and/or history of ≥2 episodes of severe hypoglycemia or recurrent symptomatic hypoglycemia 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.
• Use of weight-control medications or weight-loss surgery within 3 months before screening, or weight fluctuation exceeding 5% within 3 months.
• Clinically significant abnormal TSH, FT3, or FT4 at screening, or previous diagnosis of thyroid dysfunction, deemed unsuitable by the investigator.
• Personal or family history of multiple endocrine neoplasia type 2; personal or family history of medullary thyroid carcinoma; or thyroid nodules classified as C-TIRADS category 4 or higher on ultrasound.
• History or presence of malignant tumors (except cured basal cell carcinoma or cervical carcinoma in situ).
• History of thrombotic diseases (e.g., deep vein thrombosis, pulmonary embolism, stroke), known bleeding diathesis or coagulation dysfunction, major thrombotic event within 6 months, or any coagulation parameter ≥1.5x ULN, or clinically significant abnormal coagulation function deemed unsuitable by the investigator.
• Long-term use (over 1 month) or current use of anticoagulants (e.g., warfarin, rivaroxaban, dabigatran) or antiplatelet drugs (e.g., aspirin, clopidogrel) before screening.
• Diagnosis of significant cardiovascular or cerebrovascular disease within 6 months before screening, including but not limited to acute stroke, transient ischemic attack (TIA), acute coronary syndrome, coronary heart disease, heart failure, arrhythmia requiring treatment, etc.
• History of gout or gout attack within 6 months before screening or before enrollment.
• PR interval \>210 ms and/or QRS complex duration \>120 ms, and/or QTcF \>450 ms at rest at screening or before enrollment. If criteria not met, repeat ECG twice on the same day; use the average of 3 measurements for judgment.

Sponsors & Collaborators

• The First Affiliated Hospital of Henan University of Science and Technology: lead
• PegBio Co., Ltd.: collaborator

Central Study Contacts

Hongwei Jiang, PhD Supervisor

CONTACT

0379-69823582; jianghw@haust.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 16, 2026
• Study Start: January 13, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Starting 6 months after publication of the primary outcomes in a peer-reviewed journal.The data will remain available for access for a period of 24 months.
• Access Criteria: Access is restricted to academic researchers for non-commercial, scientific purposes