Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes

Eligibility Criteria

• 1. Men and women between the ages of 18 and 70 years old, inclusive, at the time of screening;
• 2. Females of non-childbearing potential must be ≥ 1 year post-menopausal or documented as being surgically sterile. Females of childbearing potential must agree to use two methods of contraception during the entire study and for an additional 3 months after the end of dosing with the investigational product;
• 3. Male subjects must be willing to use clinically acceptable method of contraception during the entire study and for an additional 6 months after the end of the treatment period;
• 4. Diagnosed with Type 1 diabetes based on clinical history or as defined by the current American Diabetes Association (ADA) criteria;
• 5. Treatment with a stable insulin regimen for at least 8 weeks before screening with continuous subcutaneous insulin infusion (CSII) via an insulin pump or hybrid closed loop system;
• 6. Currently using a Continuous Glucose Monitoring (CGM) system;
• 7. A1c \> 7% and ≤ 10%
• 8. eGFR ≥ 60 mL/min/1.73m²;
• 9. Able to provide written informed consent approved by an Institutional Review Board (IRB).
• 1. History or evidence of clinically significant disorder or condition that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
• 2. History of pancreatitis, medullary thyroid carcinoma or liver disease;
• 3. Clinically significant diagnosis of anemia (Hemoglobin \< 9 g/dl at screening);
• 4. Body Mass Index (BMI) \< 18.5 kg/m2 and/or weight \<50kg;
• 5. Body Mass Index (BMI) \> 35 kg/m2
• 6. Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening. Donations of plasma, packed RBCs, platelets or quantities less than 500 mL are allowed at investigator discretion;
• 7. Current or recent (within 1 month of screening) use of diabetes medications other than insulin; (examples include GLP-1 RA, SGLT-2i, Pramlintide, Metformin);
• 8. Women who are pregnant or lactating/breastfeeding;
• 9. Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits;
• 10. Any other condition(s) that might reduce the chance of obtaining study data, or that might cause safety concerns, or that might compromise the ability to give truly informed consent.