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

Inclusion Criteria:

1. Men and women between the ages of 18 and 70 years old, inclusive, at the time ofscreening;

2. Females of non-childbearing potential must be ≥ 1 year post-menopausal or documentedas being surgically sterile. Females of childbearing potential must agree to use twomethods of contraception during the entire study and for an additional 3 monthsafter the end of dosing with the investigational product;

3. Male subjects must be willing to use clinically acceptable method of contraceptionduring the entire study and for an additional 6 months after the end of thetreatment period;

4. Diagnosed with Type 1 diabetes based on clinical history or as defined by thecurrent American Diabetes Association (ADA) criteria;

5. Treatment with a stable insulin regimen for at least 8 weeks before screening withcontinuous subcutaneous insulin infusion (CSII) via an insulin pump or hybrid closedloop 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).

Exclusion Criteria:

1. History or evidence of clinically significant disorder or condition that, in theopinion of the Investigator, would pose a risk to subject safety or interfere withthe 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. Donationsof plasma, packed RBCs, platelets or quantities less than 500 mL are allowed atinvestigator discretion;

7. Current or recent (within 1 month of screening) use of diabetes medications otherthan 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 withscreening appointments or study visits;

10. Any other condition(s) that might reduce the chance of obtaining study data, or thatmight cause safety concerns, or that might compromise the ability to give trulyinformed consent.