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.
Eli Lilly and Company
Lead sponsor