Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07340320
Eligibility Criteria:
Inclusion Criteria
Participants who meet all of the following criteria will be eligible to participate in this study:
* Adults aged 18 to 75.
* Diagnosis of type 2 diabetes for at least 6 months.
* HbA1c between 7.0% and 10.5%.
* Body mass index (BMI) between 23 and 50 kg/m².
* Body weight stable for the past 3 months before joining.
* Stable dose of metformin, with or without a stable dose of an SGLT2 inhibitor, for at least 3 months.
* Individuals who could become pregnant or could father a child must be willing and able to use highly effective birth control.
Exclusion Criteria
Participants who meet any of the following criteria will be excluded from this study:
* Type 1 diabetes or a history of diabetic ketoacidosis.
* Use of any GLP-1 receptor agonist within the past 6 months, or any prior exposure to CX11.
* Use of insulin to control blood sugar within the past 12 months.
* More than one episode of severe low blood sugar, with awareness of hypoglycemia symptoms.
* Cardiovascular or cerebrovascular conditions within the past 6 months:
* Heart attack, coronary angioplasty, or bypass surgery (diagnostic angiography allowed).
* Valvular heart disease or prior heart valve repair surgery.
* Unstable angina.
* Transient ischemic attack (TIA) or stroke.
* Decompensated heart failure (NYHA Class III or IV).
* ECG abnormalities indicating significant safety risk, such as supraventricular tachycardia, torsades de pointes, second- or third-degree AV block, myocardial infarction, QTcF \> 450 ms in males or \> 470 ms in females, PR interval \> 220 ms.
* Poorly controlled hypertension at screening: systolic ≥ 180 mmHg or diastolic ≥ 100 mmHg.
* Pancreatic or gallbladder conditions:
* Acute or chronic pancreatitis.
* Symptomatic gallbladder disease.
* Pancreatic injury or risk factors that increase pancreatitis risk.
* Thyroid conditions:
* Poorly controlled abnormal thyroid function on a stable dose before screening.
* Clinically significant abnormal thyroid test results at screening.
* Personal or first-degree family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type 2A or 2B.
* Cancer history:
* Malignancy within the past 5 years, regardless of recurrence or metastasis. Exceptions: localized basal cell skin cancer, low-risk prostate cancer, cervical carcinoma in situ, or high-grade prostatic intraepithelial neoplasia.
* Gastrointestinal conditions or treatments that may affect drug absorption:
* Abnormal gastric emptying (e.g., gastric outlet obstruction).
* Severe chronic gastrointestinal disease, including active ulcer within 6 months.
* Crohn's disease, ulcerative colitis, or other inflammatory bowel diseases.
* Prior gastrointestinal surgery (except polypectomy and appendectomy).
* Long-term use of drugs that directly affect gastrointestinal motility (e.g., mosapride, cisapride).
* Liver disease:
* Active liver disease other than nonalcoholic fatty liver.
* Chronic active hepatitis B or C.
* Primary biliary cirrhosis.
* Eye disease:
* Uncontrolled or potentially unstable diabetic retinopathy or maculopathy.
* Abnormal lab results at screening:
* eGFR \< 60 mL/min/1.73 m² (CKD-EPI).
* ALT or AST \> 2.5 × upper limit of normal (ULN).
* Total bilirubin \> 1.5 × ULN (except known Gilbert's syndrome).
* Serum amylase or lipase \> 1.5 × ULN.
* Fasting triglycerides \> 5.7 mmol/L.
* TSH \> 1.5 × ULN.
* Calcitonin ≥ 20 ng/L.
* Hemoglobin \< 110 g/L (male) or \< 100 g/L (female).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07340320
Study Brief:
Protocol Section:
NCT07340320