The primary objective of Study GZQG is to compare the effect of retatrutide and placebo on total clamp disposition index (cDI) after 28 weeks of treatment.
Have been diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 6 months prior to screening.
Treated with diet and exercise and metformin daily, with or without other allowed oral antihyperglycaemia medications (OAMs), 3 months prior to screening. Allowed OAMs are dipeptidyl peptidase-4 inhibitors (DPP-IV) inhibitors, sodium/glucose cotransporter 2 (SGLT2) inhibitors, glinides, and sulfonylureas.
6.5% and ≤ 9.5 % if on metformin with or without SGLT2 inhibitors, or
6% and ≤8.5% if on metformin in combination with allowed OAMs that require washout.
Have Type 1 Diabetes Mellitus (T1DM)
Have had more than 1 episode of severe hypoglycaemia, as defined by the American Diabetes Association criteria, within 6 months before screening or a history of hypoglycaemia unawareness or poor recognition of hypoglycaemic symptoms; any participant that cannot communicate an understanding of hypoglycaemic symptoms and the appropriate treatment of hypoglycaemia prior to the first dose of study drug should also be excluded.
Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalisation within the 6 months prior to screening.
Are currently receiving, planning to receive, or in need of treatment, that is, intravitreal injections of Vascular Endothelial Growth Factor inhibitor or corticosteroids, focal/grid macular laser surgery, panretinal photocoagulation, or vitrectomy for diabetic retinopathy at screening.
Parallel
Retatrutide
DrugAdministered SC
Semaglutide
DrugAdministered SC
Placebo
DrugAdministered SC
Change from Baseline in Total Clamp Disposition Index (cDI) for Comparison of Retatrutide With Placebo
Change from baseline in total cDI for comparison of retatrutide with placebo
Change from Baseline in cDI for Comparison Between Retatrutide and Semaglutide
Change from baseline in total cDI for comparison between retatrutide and semaglutide
Change from Baseline in Hyperinsulinemic Euglycemic Clamp M-value
Change from baseline in hyperinsulinemic euglycemic clamp M-value
Change from Baseline in First Phase Incremental Insulin Secretion Rate (ISR)
Change from baseline in first phase ISR.
Change from Baseline in Second Phase Total ISR
Change from baseline in second phase total ISR
Click on the lead sponsor to view all of their trials.
