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New treatment option for T2DM
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
ClinicalTrials.gov ID: NCT07347080
What this study is testing
What is Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059））?
Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059）） is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for t2dm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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...
- Patients who have failed treatment with diet and exercise alone, or metformin monotherapy, or a stable regimen for 12 weeks of metformin (dose ≥1500...
- 18.5 kg/m²≤Body Mass Index (BMI) ≤40.0 kg/m² at screening and enrollment
- people 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...
You likely can't join 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...
- 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...
- Allergic constitution (allergy to ≥2 types of drugs or foods) or keloid tendency, or clear history of drug allergy, or investigator suspects...
- Fasting plasma glucose \<3.9 mmol/L at screening or before enrollment, and/or history of ≥2 episodes of severe hypoglycemia or recurrent symptomatic...
- History or presence of Cushing's syndrome, polycystic ovary syndrome, or other hereditary endocrine diseases, or obesity secondary to factors such as...
See the full eligibility criteria
Who can join
- 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...
- 18.5 kg/m²≤Body Mass Index (BMI) ≤40.0 kg/m² at screening and enrollment
- people 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- History of gout or gout attack within 6 months before screening or before enrollment.
- Untreated or poorly controlled hypertension (systolic BP \>160 mmHg and/or diastolic BP \>100 mmHg) at screening or before enrollment. Patients on antihypertensive therapy must have a stable regimen and dose for 1...
- Heart rate at rest (after at least 10 min) \ 100 bpm at screening or before enrollment. One re-test is allowed. Exclusion if both readings fail.
- 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...
- History of clinically significant chronic or acute exacerbating respiratory diseases, including but not limited to asthma, COPD (excluding obstructive sleep apnea).
- History of severe gastrointestinal disease (e.g., active ulcer, gastroparesis, pyloric obstruction, inflammatory bowel disease) within 6 months before screening or before enrollment, or gastrointestinal surgery, or...
- Severe renal disease or estimated Glomerular Filtration Rate (eGFR) \<60 mL/min/1.73m² (CKD-EPI formula) at screening or before enrollment.
- Serum amylase or lipase \>3x Upper Limit of Normal (ULN) at screening or before enrollment, or history/known chronic pancreatitis, acute pancreatitis, pancreatic injury.
- History of cholelithiasis, acute or chronic cholecystitis (except those with no residual biliary stones post-treatment or post-cholecystectomy without sequelae, deemed eligible by the investigator).
- Severe dyslipidemia, with LDL-C ≥4.40 mmol/L or triglycerides (TG) ≥5.65 mmol/L at screening or before enrollment. If on lipid-lowering therapy, regimen and dose must be stable for 1 month.
- Clear history of psychiatric disorders (e.g., depression, schizophrenia, bipolar disorder) within 2 years before screening.
- Major surgery within 1 month before screening, or presence of severe infection or active inflammation.
- History of blood donation \>400 mL, transfusion, or blood loss within 90 days before screening or before enrollment.
- Any of the following laboratory abnormalities at screening or before enrollment: 1. ALT or AST \>2x ULN; 2. Total Bilirubin \>1.5x ULN; 3. Calcitonin ≥35 pg/mL; 4. Hemoglobin \<110 g/L (female) or \<120 g/L (male); 5...
- Use of any approved or unapproved weight-affecting drugs or products within 3 months before screening, including but not limited to orlistat, phentermine-topiramate, naltrexone-bupropion, systemic corticosteroids...
- Use of any DPP-4 inhibitor, or GLP-1, GIP, GCG receptor agonists, or FGF-21 within 6 months before screening.
- History of bariatric surgery (except liposuction/abdominoplasty \>1 year prior).
- Participation in any drug or medical device clinical trial within 3 months before screening or before enrollment (except screen failures).
- Positive serology for HBsAg, anti-HCV antibody, anti-TP antibody, or anti-HIV antibody at screening.
- History of drug abuse and/or alcoholism (weekly alcohol intake \>14 units) within 6 months before screening
- Positive urine drug screen or alcohol breath test at screening.
- Pregnant or lactating females, or people using oral contraceptives.
- Intolerance to venipuncture or history of needle syncope, blood-injury syncope.
- Any other physiological, psychological, or situational condition deemed by the investigator as unsuitable for trial participation.
The study team makes the final eligibility decision.
Where it's taking place
- Luoyang, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Luoyang, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.