A Phase 3, Randomized, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly Compared With Semaglutide Once Weekly in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06260722Tipo: INTERVENTIONALInicio: 21 de feb de 2024Fin estimado: 1 de ene de 2027

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have HbA1c ≥ 7.0% (53 millimoles per mole (mmol/mol)) to ≤ 10.5% (91 mmol/mol)
Have Type 2 Diabetes (T2D)
Have been on a stable diabetes treatment consisting of metformin ≥ 1500 milligrams per day (mg/day) with or without SGLT2i during 90 days prior to screening
Are of stable weight for at least 90 days prior to screening
Have a Body Mass Index (BMI) ≥ 25.0 kilograms per meter squared (kg/m\^2)

Criterios de exclusión

Have Type 1 Diabetes (T1D)
Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening
Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening
Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
Have an estimated glomerular filtration rate (eGFR) \<45 milliliters/minute/1.73 meter squared (mL/min/1.73 m\^2) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory
Have a prior or planned surgical treatment for obesity
Have New York Heart Association Functional Classification IV congestive heart failure
Have had an acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening
Have a known clinically significant gastric emptying abnormality
Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
Have any lifetime history of a suicide attempt
Had chronic or acute pancreatitis
Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2
Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening.

Intervenciones

drug

Semaglutide

Administered SC.

drug

Retatrutide

Administered SC.