Phase
3
Condition
Diabetes Prevention
Metabolic Disorders
Diabetes Mellitus, Type 2
Treatment
Semaglutide
Retatrutide
Clinical Study ID
NCT06260722
18805
J1I-MC-GZBZ
Ages > 18 All Genders
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.
Inclusion Criteria:
Have Type 2 Diabetes (T2D)
Have HbA1c ≥ 7.0% (53 millimoles per mole (mmol/mol)) to ≤ 10.5% (91 mmol/mol)
Have been on a stable diabetes treatment consisting of metformin ≥ 1500 milligramsper 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)
Exclusion Criteria:
Have Type 1 Diabetes (T1D)
Have a history of ketoacidosis or hyperosmolar state or coma within the last 6months prior to screening
Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6months prior to screening
Are currently receiving or planning to receive treatment for diabetic retinopathyand/or macular edema
Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73meter squared (mL/min/1.73 m^2) or lower than the country-specific threshold fordiscontinuing metformin therapy per local label as determined by the centrallaboratory
Have a prior or planned surgical treatment for obesity
Have New York Heart Association Functional Classification IV congestive heartfailure
Have had an acute myocardial infarction, stroke, or were hospitalized for congestiveheart 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 aclinically 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 multipleendocrine 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.
Semaglutide
3
February 21, 2024
January 31, 2027
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