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:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT07139405
Eligibility Criteria:
Inclusion Criteria:
1. Males and females, age 18 and ≤70 at time of screening visit
2. WOCBP must have negative serum or urine pregnancy test (min sensitivity 25 IU/L or equivalent HCG) within 24 hours prior to the start of the study
3. Women must not be breastfeeding
4. Inadequate BG control with Metformin defined as a screening HbA1c of ≥7.0 and ≤ 10.5 at the screening visit
5. Subjects should have been taking the same daily dose of Metformin for at least 8 weeks prior to the enrolment visit and subjects must not receive other antihyperglycemic medications within the 12 weeks prior to screening
6. FPG ≥140 mg/dL
7. BMI ≥28 and ≤40
8. Grade 1 hypertension defined as 140-159 systolic and 90-99 diastolic mmHg if patients is not receiving anti-hypertensive medication at the time of screening / or has never received anti-hypertensive medication.
If patient is receiving anti-hypertensive medication at the time of screening and their BP is controlled, BP should be within the normal range of \<120-139 systolic and \<80-89 diastolic.
Patients receiving anti-hypertensive medication at the time of screening and for which their hypertension is uncontrolled, will be excluded
9. eGFR ≥ 60 ml/min
Exclusion Criteria:
1. Patients with Type 1 Diabetes
2. Patients with history of ketoacidosis
3. Subjects at serious risk of GI adverse events per the discretion of the study site investigator (e.g current or recent history of GI bleeding ulceration, or perforation)
4. Subjects with a planned radiologic study with IV contrast, surgery, or other planned procedures that may predispose them to metformin-associated lactic acidosis
5. Subjects with a history of uncontrolled hyperglycemia (\>15.0 mmol/L) after an overnight fast that required rescue therapy
6. Impaired kidney function defined as eGFR ≤60 mL/min
7. Subjects taking any prohibited medications.
8. Any of the following cardiovascular (CV)/vascular diseases within 3 months of the screening visit:
1. Myocardial infarction (MI)
2. Cardiac surgery or revascularization (coronary artery bypass surgery, Coronary Artery Bypass Graft \[(CABG\]/Percutaneous transluminal coronary angioplasty (PTCA)\]
3. Unstable angina
4. Unstable congestive heart failure (CHF)
5. Transient ischemic attack (TIA) or significant cerebrovascular disease
6. Unstable or previously diagnosed arrhythmia
7. Congestive heart failure, defined as New York Heart Association (NYHA) Class III and IV, unstable or acute heart failure and/or known left ventricular ejection fraction of ≤40%.
8. Acute coronary syndrome, stroke or transient ischemic attack within 3 months prior to the informed consent
9. Previous bariatric surgery
10. Previous bariatric surgery
11. Treatment with anti-obesity drugs within 3 months prior to screening visit
12. Subjects with COPD
13. Subjects with active liver disease
14. Subjects with active renal disease
15. Subjects with autoimmune diseases e.g. Lupus, Psoriasis
16. Subjects with HIV / AIDS
17. Subjects with Hematological and Oncological Diseases/Conditions
18. Haemoglobin \<11.0 g/dL (110 g/L) for men; haemoglobin \<10.0 g/dL (100 g/L) for women
19. Subjects with chronic disease e.g. Cancer, Epilepsy, Alzheimer, Parkinson
20. Subjects with abnormal free T4
21. Subjects with serious active infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07139405
Study Brief:
Protocol Section:
NCT07139405