[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619627":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":43,"collaborators":45,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":11,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":11,"overallStatus":28,"whyStopped":11,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"The First Affiliated Hospital of Henan University of Science and Technology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Exenatide Circular RNA-Lipid Nanoparticle Injection（CR059）","EXPERIMENTAL",null,[13],"Drug: Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059））",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059））","use one dose per person",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Hongwei Jiang, PhD Supervisor","CONTACT","0379-69823582","jianghw@haust.edu.cn",[27],{"facility":5,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"RECRUITING","Luoyang","Henan","310015","China","CN",{"type":35,"coordinates":36},"Point",[37,38],112.43684,34.67345,{"lat":38,"lon":37},[41],{"name":42,"role":23,"phone":24,"phoneExt":11,"email":25},"Hongwei Jiang, Professor",{"type":44,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[46],{"name":47,"class":6},"PegBio Co., Ltd.","100619627","early-phase-1-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-100619627",false,"NCT07347080","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","A Single-Center, Open-Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Exenatide Circular RNA-Lipid Nanoparticle Injection (CR059) in Chinese Subjects With Type 2 Diabetes Mellitus","CR059101","Inclusion Criteria:\n\n* Chinese male or female， 18≤age≤-65 years .\n* 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.\n* 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\u002Fday or maximum tolerated dose ≥1000 mg\u002Fday) 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\u002F2 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 \\\u003C13.0 mmol\u002FL, and 7.5%≤HbA1c ≤ 10.0%.\n* 18.5 kg\u002Fm²≤Body Mass Index (BMI) ≤40.0 kg\u002Fm² at screening and enrollment\n* 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.\n* Able to understand and willing to sign the informed consent form, and fully understand the trial content, procedures, and potential adverse reactions.\n* Able to complete the trial according to the protocol requirements.\n\nExclusion Criteria:\n\n* 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).\n* History of acute diabetic complications, such as ketoacidosis or hyperosmolar coma, within 6 months before screening.\n* 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.\n* 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.\n* Fasting plasma glucose \\\u003C3.9 mmol\u002FL at screening or before enrollment, and\u002For history of ≥2 episodes of severe hypoglycemia or recurrent symptomatic hypoglycemia within 6 months before screening.\n* History or presence of Cushing's syndrome, polycystic ovary syndrome, or other hereditary endocrine diseases, or obesity secondary to factors such as hormones.\n* Use of weight-control medications or weight-loss surgery within 3 months before screening, or weight fluctuation exceeding 5% within 3 months.\n* Clinically significant abnormal TSH, FT3, or FT4 at screening, or previous diagnosis of thyroid dysfunction, deemed unsuitable by the investigator.\n* 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.\n* History or presence of malignant tumors (except cured basal cell carcinoma or cervical carcinoma in situ).\n* 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.\n* 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.\n* 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.\n* History of gout or gout attack within 6 months before screening or before enrollment.\n* Untreated or poorly controlled hypertension (systolic BP \\>160 mmHg and\u002For diastolic BP \\>100 mmHg) at screening or before enrollment. Patients on antihypertensive therapy must have a stable regimen and dose for 1 month. If BP criteria are not met at screening\u002Fenrollment, one re-test is allowed. Exclusion if both readings fail.\n* Heart rate at rest (after at least 10 min) \\\u003C50 bpm or \\>100 bpm at screening or before enrollment. One re-test is allowed. Exclusion if both readings fail.\n* PR interval \\>210 ms and\u002For QRS complex duration \\>120 ms, and\u002For 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.\n* History of clinically significant chronic or acute exacerbating respiratory diseases, including but not limited to asthma, COPD (excluding obstructive sleep apnea).\n* 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 long-term use of drugs directly affecting GI motility due to chronic GI disease, deemed unsuitable by the investigator.\n* Severe renal disease or estimated Glomerular Filtration Rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73m² (CKD-EPI formula) at screening or before enrollment.\n* Serum amylase or lipase \\>3x Upper Limit of Normal (ULN) at screening or before enrollment, or history\u002Fknown chronic pancreatitis, acute pancreatitis, pancreatic injury.\n* 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).\n* Severe dyslipidemia, with LDL-C ≥4.40 mmol\u002FL or triglycerides (TG) ≥5.65 mmol\u002FL at screening or before enrollment. If on lipid-lowering therapy, regimen and dose must be stable for 1 month.\n* Clear history of psychiatric disorders (e.g., depression, schizophrenia, bipolar disorder) within 2 years before screening.\n* Major surgery within 1 month before screening, or presence of severe infection or active inflammation.\n* History of blood donation \\>400 mL, transfusion, or blood loss within 90 days before screening or before enrollment.\n* 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\u002FmL; 4. Hemoglobin \\\u003C110 g\u002FL (female) or \\\u003C120 g\u002FL (male); 5. Clinically significant abnormal platelet count; 6. Clinically significant abnormal white blood cell or neutrophil count;\n* 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, antidepressants (SSRIs, SNRIs, tricyclics, tetracyclics), antipsychotics\u002Fsedatives (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid, lithium), etc.\n* Use of any DPP-4 inhibitor, or GLP-1, GIP, GCG receptor agonists, or FGF-21 within 6 months before screening.\n* History of bariatric surgery (except liposuction\u002Fabdominoplasty \\>1 year prior).\n* Participation in any drug or medical device clinical trial within 3 months before screening or before enrollment (except screen failures).\n* Positive serology for HBsAg, anti-HCV antibody, anti-TP antibody, or anti-HIV antibody at screening.\n* History of drug abuse and\u002For alcoholism (weekly alcohol intake \\>14 units) within 6 months before screening\n* Positive urine drug screen or alcohol breath test at screening.\n* Pregnant or lactating females, or subjects using oral contraceptives.\n* Intolerance to venipuncture or history of needle syncope, blood-injury syncope.\n* Any other physiological, psychological, or situational condition deemed by the investigator as unsuitable for trial participation.","ALL","18 Years","65 Years",{"count":60,"type":61},9,"ESTIMATED","INTERVENTIONAL",[64],"EARLY_PHASE1","Primary Objectives:\n\n•To evaluate the safety and tolerability of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（CR059）in Chinese subjects with T2DM.\n\nSecondary Objectives:\n\n* To characterize the pharmacokinetic (PK) profile of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（CR059） in Chinese subjects with T2DM;\n* To characterize the pharmacodynamic (PD) profile of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059） in Chinese subjects with T2DM;\n* To evaluate the immunogenicity of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059） in Chinese subjects with T2DM;\n\nParticipants :\n\nDiagnosed with T2DM for at least 3 months but less than 5 years, according to the Chinese Diabetes Society's diagnostic criteria",[67],"T2DM","2026-03-31",{"date":70,"type":71},"2026-04-06","ACTUAL",{"date":73,"type":71},"2026-01-20",{"date":75,"type":61},"2026-08-31",{"name":5,"class":6},1]