T2DMEarly Phase 1CR059101NCT07347080
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 Early Phase 1 study testing Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059）） in people with T2DM, run by The First Affiliated Hospital of Henan University of Science and Technology at 1 site in China.
Trial 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）… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- T2DM
- What is being tested?
- Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059））
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2026to 31 Aug 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 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%.
- 18.5 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.
Who cannot join
- 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.
Show all 37Show fewer
- 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.
- 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 month. If BP criteria are not met at screening/enrollment, one re-test is allowed. Exclusion if both readings fail.
- Heart rate at rest (after at least 10 min) <50 bpm or >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 judgment.
- 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 long-term use of drugs directly affecting GI motility due to chronic GI disease, deemed unsuitable by the investigator.
- 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. Clinically significant abnormal platelet count; 6. Clinically significant abnormal white blood cell or neutrophil count;
- 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/sedatives (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid, lithium), etc.
- 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 subjects 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 310015
Hongwei Jiang, Professor, 0379-69823582, jianghw@haust.edu.cn
About this study
Official title: 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
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.
Read more
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
Read the detailed description
This is a single-center, open-label, single ascending dose study designed to evaluate the safety, tolerability, PK, PD, and immunogenicity of Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059）in Chinese subjects with T2DM. It is planned to enroll 6-9 subjects.The study includes three dose cohorts (low, medium, high: 4 μg/kg, 8 μg/kg, 12 μg/kg). Each cohort plans to enroll 2-3 T2DM subjects. A single dose will be administered, with subjects observed in-hospital for at least 7 days.
- Conditions
- T2DM
- Being tested
- Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059））
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059））Drug
use one dose per person
| Study group | Role | What they receive |
|---|---|---|
| Exenatide Circular RNA-Lipid Nanoparticle Injection（CR059） | Experimental | Not described Receives: Drug: Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059）） |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the first dosing (Day 1 ) of study drug until completion of the post treatment follow-up visit(Day 36)
Secondary outcomes (12)
Pharmacokinetic
Cmax
Measured: From the first dose (Day 1 ) of study drug until Day 36
Pharmacokinetic
Tmax
Measured: From the first dose (Day 1 ) of study drug until Day 36
Pharmacokinetic
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration（AUC0-last）
Measured: From the first dose (Day 1 ) of study drug until Day 36
Pharmacokinetic
Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC0-inf)
Measured: From the first dose (Day 1 ) of study drug until Day 36
Pharmacokinetic
Apparent Clearance (CL/F)
Measured: From the first dose (Day 1 ) of study drug until Day 36
Pharmacokinetic
Apparent Volume of Distribution (VZ/F)
Measured: From the first dose (Day 1 ) of study drug until Day 36
Pharmacokinetic
Elimination Half-Life (t1/2)
Measured: From the first dose (Day 1 ) of study drug until Day 36
Anti-Drug Antibodies
ADA positivity rate
Measured: Day 1 (first dosing day)、Day 15、Day 29
Pharmacodynamics
Plasma Glucose
Measured: From the baseline(Day 2)until completion of the post treatment follow-up visit (Day 36)(Day 1 :first dosing day)
Pharmacodynamics
Serum C-peptide
Measured: From the baseline(Day 2)until completion of the post treatment follow-up visit(Day 36)(Day 1 :first dosing day)
Pharmacodynamics
Serum insulin
Measured: From the baseline(Day 2)until completion of the post treatment follow-up visit(Day 36)(Day 1 :first dosing day)
Anti-Drug Antibodies
ADA titer
Measured: Day 1(first dosing day)、Day 15、Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start20 Jan 2026
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Henan University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- PegBio Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347080
- Sponsor's protocol ID
- CR059101
- Acronym
- CR059101
- Status last verified
- Mar 2026
- First submitted
- 29 Dec 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: underlie the results reported in this study-including demographics, baseline characteristics, efficacy, and safety data-will be shared with researchers who provide a methodologically sound proposal, starting 6 months after publication of the primary outcomes in a peer-reviewed journal.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07347080
- Acronym / sponsor ID
- CR059101 / CR059101
- Conditions
- T2DM
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Henan University of Science and TechnologyUniversity, hospital or other
- Collaborators
- PegBio Co., Ltd.
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a single-center, open-label, single ascending dose study designed to evaluate the safety, tolerability, PK, PD, and immunogenicity of Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059）in Chinese subjects with T2DM. It is planned to enroll 6-9 subjects.The study includes three dose cohorts (low, medium, high: 4 μg/kg, 8 μg/kg, 12 μg/kg). Each cohort plans to enroll 2-3 T2DM subjects. A single dose will be administered, with subjects observed in-hospital for at least 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exenatide Circular RNA-Lipid Nanoparticle Injection（CR059） | Experimental | Drug: Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059）） |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%.
- 18.5 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.
Key exclusion criteria (37 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059））use one dose per person | Drug | Exenatide Circular RNA-Lipid Nanoparticle Injection（CR059） |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From the first dosing (Day 1 ) of study drug until completion of the post treatment follow-up visit(Day 36)
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.
12 secondary outcomes
Pharmacokinetic
Time frame: From the first dose (Day 1 ) of study drug until Day 36
Pharmacokinetic
Time frame: From the first dose (Day 1 ) of study drug until Day 36
Pharmacokinetic
Time frame: From the first dose (Day 1 ) of study drug until Day 36
Pharmacokinetic
Time frame: From the first dose (Day 1 ) of study drug until Day 36
Pharmacokinetic
Time frame: From the first dose (Day 1 ) of study drug until Day 36
Pharmacokinetic
Time frame: From the first dose (Day 1 ) of study drug until Day 36
Pharmacokinetic
Time frame: From the first dose (Day 1 ) of study drug until Day 36
Anti-Drug Antibodies
Time frame: Day 1 (first dosing day)、Day 15、Day 29
Pharmacodynamics
Time frame: From the baseline(Day 2)until completion of the post treatment follow-up visit (Day 36)(Day 1 :first dosing day)
Pharmacodynamics
Time frame: From the baseline(Day 2)until completion of the post treatment follow-up visit(Day 36)(Day 1 :first dosing day)
Pharmacodynamics
Time frame: From the baseline(Day 2)until completion of the post treatment follow-up visit(Day 36)(Day 1 :first dosing day)
Anti-Drug Antibodies
Time frame: Day 1(first dosing day)、Day 15、Day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: Yes. underlie the results reported in this study-including demographics, baseline characteristics, efficacy, and safety data-will be shared with researchers who provide a methodologically sound proposal, starting 6 months after publication of the primary outcomes in a peer-reviewed journal.
Related trials for T2DM
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Not yet recruitingObservational study
Sarcopenia Risk in Obese T2DM Patients
Sarcopenia, Obesity Type 2 Diabetes Mellitus
Active, not recruiting
Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity
Hypertension, Type 2 Diabetes Mellitus (T2DM)
Not yet recruiting
Supplementation of Inulin + L. Acidophilus in Elders With T2DM
Diabetes Mellitus, Microbiome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059）） in people with T2DM, run by The First Affiliated Hospital of Henan University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongwei Jiang, PhD Supervisor (0379-69823582, jianghw@haust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (TEAEs) (time frame: From the first dosing (Day 1 ) of study drug until completion of the post treatment follow-up visit(Day 36)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.