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

Inclusion Criteria: Men and women between the ages of 18 and 70 years old, inclusive, at the time of screening; 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; 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; Diagnosed with Type 1 diabetes based on clinical history or as defined by the current American Diabetes Association (ADA) criteria; 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; Currently using a Continuous Glucose Monitoring (CGM) system; A1c > 7% and ≤ 10% eGFR ≥ 60 mL/min/1.73m²; Able to provide written informed consent approved by an Institutional Review Board (IRB). Exclusion Criteria: 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; History of pancreatitis, medullary thyroid carcinoma or liver disease; Clinically significant diagnosis of anemia (Hemoglobin < 9 g/dl at screening); Body Mass Index (BMI) < 18.5 kg/m2 and/or weight <50kg; Body Mass Index (BMI) > 35 kg/m2 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; Current or recent (within 1 month of screening) use of diabetes medications other than insulin; (examples include GLP-1 RA, SGLT-2i, Pramlintide, Metformin); Women who are pregnant or lactating/breastfeeding; Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits; 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.