A Clinical Study to Evaluate the Effects of Enicepatide Versus Tirzepatide in Participants With Type 2 Diabetes and Inadequate Blood Sugar Control on Oral Glucose-Lowering Medications

Korábbi kezelés

• History of ketoacidosis or hyperosmolar state/coma within 12 months prior to screening
• One or more episodes of Level 3 hypoglycemia (per 2026 American Diabetes Association (ADA) Standards of Care in Diabetes) and/or one or more episodes of hypoglycemia unawareness within the 6 months prior to screening
• Self-reported change in body weight of more than 5 kilogram (kg) gain or loss within 90 days prior to screening
• Treatment with any approved, investigational, compounded, or biosimilar versions of GLP-1 RA-based therapy (e.g., GLP-1 receptor agonist, GLP-1/GIP receptor agonist/antagonist, GLP-1/Glucagon receptor agonist, or GLP-1/GIP/Glucagon receptor agonist) or amylin analog within 6 months prior to randomization
• Prior non-response or intolerance to contemporary GLP-1 RA-based therapies

Más betegség

• History of type 1 diabetes mellitus (T1DM) diagnosis

Laborértékek

• Used any injectable glucose-lowering medication during the 90 days prior to screening, and throughout the screening period until randomization. Short term treatment with insulin for \<14 days is permitted for necessary clinical situations
• Estimated glomerular filtration rate (eGFR) \<15 milliliters per minute per 1.73 square meters (mL/min/1.73 m2)

Egyéb

• Body Mass Index (BMI) \<25.0 kg/square meter (m2) at screening

• Have a diagnosis of type 2 diabetes mellitus (T2DM) based on World Health Organization (WHO) classification or other locally applicable diagnostic standards and have inadequate glycemic control in the opinion of the investigator
• Have a HbA1c of ≥7.5% to ≤10.5% (or 58 millimole (mmol)/mol to 91 mmol/mol) at screening
• Receiving stable T2DM treatment with oral glucose-lowering medication, during the 90 days prior to screening, and throughout the screening period until randomization; Dose of oral glucose-lowering medication is considered stable if the dose was unchanged during this 90-day period
• Agree to not initiate a new diet, fast, and/or exercise program during the study which may result in changes in body weight or HbA1c, other than the standard of care lifestyle and dietary measures for diabetes treatment