Actively Recruiting
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
Led by The First Affiliated Hospital of Henan University of Science and Technology · Updated on 2026-04-06
9
Participants Needed
1
Research Sites
31 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Henan University of Science and Technology
Lead Sponsor
P
PegBio Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chinese male or female aged between 18 and 65 years
- Diagnosed with type 2 diabetes mellitus for at least 3 months but less than 5 years according to Chinese guidelines
- Have failed treatment with diet and exercise alone, or metformin monotherapy, or a stable combination of metformin and another specified oral antidiabetic drug for at least 12 weeks
- Fasting plasma glucose less than 13.0 mmol/L and HbA1c between 7.5% and 10.0%
- Body mass index between 18.5 kg/m² and 40.0 kg/m² at screening and enrollment
- No pregnancy plans during the study and willing to use effective contraception until 3 months after last dose
- Able to understand and sign informed consent and comply with trial procedures
- Able to complete the trial according to protocol requirements
You will not qualify if you...
- Diagnosis of type 1 diabetes or diabetes caused by pancreatic or other specific diseases
- History of acute diabetic complications within 6 months before screening
- Severe chronic diabetic complications within 6 months before screening deemed unsuitable for participation
- Allergies to multiple drugs or foods, history of drug allergy, or suspected allergy to study drug or similar drugs
- Fasting plasma glucose under 3.9 mmol/L or history of severe or recurrent hypoglycemia within 6 months
- History or presence of endocrine disorders like Cushing's syndrome or polycystic ovary syndrome
- Use of weight control drugs or surgery within 3 months before screening or significant recent weight changes
- Abnormal thyroid function or history of thyroid diseases deemed unsuitable
- Personal or family history of certain thyroid cancers or nodules
- History or presence of malignant tumors except some cured cancers
- History of thrombotic or bleeding disorders or use of anticoagulant or antiplatelet drugs
- Significant cardiovascular or cerebrovascular disease within 6 months before screening
- History of gout within 6 months before screening
- Poorly controlled hypertension or abnormal heart rate or ECG findings
- Significant chronic or acute respiratory diseases
- Severe gastrointestinal diseases or surgery affecting gastrointestinal function
- Severe kidney disease or low estimated glomerular filtration rate
- Elevated pancreatic enzymes or history of pancreatitis
- History of gallbladder diseases except certain treated cases
- Severe dyslipidemia with unstable lipid-lowering therapy
- History of psychiatric disorders within 2 years
- Recent major surgery, severe infection, or active inflammation
- Recent blood donation, transfusion, or significant blood loss
- Certain abnormal laboratory test results at screening
- Use of weight-affecting drugs within 3 months
- Use of DPP-4 inhibitors or certain receptor agonists within 6 months
- History of bariatric surgery except certain cosmetic procedures
- Participation in other clinical trials within 3 months
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- History of drug abuse or alcoholism within 6 months
- Positive drug or alcohol screening at enrollment
- Pregnant or lactating females or use of oral contraceptives
- Intolerance to venipuncture or history of needle-related syncope
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China, 310015
Actively Recruiting
Research Team
H
Hongwei Jiang, PhD Supervisor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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