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

Exclusion Criteria10

• 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.