Semaglutide Tested for Kidney Disease in Type 1 Diabetes

Trial details

Who runs it

University of Washington

Trial code

NCT05822609

Record updated

2 June 2026

Original description

The primary objective of this study is to determine the effects of semaglutide on change in albuminuria from baseline to 26 weeks in type 1 diabetes. The secondary objective is to determine the effects of semaglutide on change in kidney parameters (including kidney oxygenation and function) measured by MRI from baseline to 26 weeks in type 1 diabetes. Other objectives are to determine the glycemic effects and safety of semaglutide in type 1 diabetes.Read full original descriptionShow less

Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes

The primary objective of this study is to determine the effects of semaglutide on change in albuminuria from baseline to 26 weeks in type 1 diabetes. The secondary objective is to determine the effects of semaglutide on change in kidney parameters (including kidney oxygenation and function) measured by MRI from baseline to 26 weeks in type 1 diabetes. Other objectives are to determine the glycemic effects and safety of semaglutide in type 1 diabetes.

Inclusion: Adults (≥18 years) with type 1 diabetes; Diabetes duration of ≥5 years; Persistent urine albumin-to-creatinine ratio (UACR) ≥ 30 mg/g, on the most recent two measurements within the prior 3 years; Estimated glomerular filtration rate ≥ 20 mL/min/1.73m2; Stable doses of drugs altering blood pressure (e.g., Angiotensin-converting enzyme inhibitor) required for at least 4 weeks prior to randomization, and requested for the duration of the trial; Stable doses of lipid-lowering medications required for at least 4 weeks prior to randomization, and requested for the duration of the trial; Adequate contraceptive method for females of child-bearing potential.

Exclusion: The receipt of any investigational drug within 3 months prior to this trial; Previously randomized in this trial; Other causes of diabetes mellitus, including type 2 diabetes and maturity-onset diabetes of the young (MODY); Chronic kidney disease unrelated to diabetes; Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) or thyroid nodule palpated by endocrinologist at screening; Personal history of pancreatitis; Uncontrolled thyroid disease or hypertension (Systolic blood pressure [SBP] ≥ 160 mm Hg or diastolic blood pressure [DBP] ≥ 100 mm Hg despite treatment); Pramlintide and the use of glycemia treatments not approved for type 1 diabetes by the FDA, e.g., metformin, SGT-2 inhibitor, GLP-1 receptor agonist, closed loop insulin delivery using unapproved algorithms; Significant systemic conditions or treatment such as cancer or immunomodulators; Known or suspected allergy/sensitivity to semaglutide or its excipients; HbA1c >9%, recent diabetic ketoacidosis, hyperosmolar hyperglycemic state or severe illness requiring hospitalization in past 30 days; Frequent hypoglycemia during the last two weeks of the study run-in phase (time below range [<70 mg/dL] ≥4%); Known liver disease other than non-alcoholic fatty liver disease (NAFLD) or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >100 IU/L, history of severe gastrointestinal disease (e.g., gastroparesis) or gallstones; Current/planned pregnancy or nursing; Proliferative retinopathy with treatment in the past 6 months; Uncontrolled or potentially unstable diabetic retinopathy or maculopathy, verified by fundus examination with pupil dilation unless performed using a digital fundus photography camera specified for non-dilated examination; More than 2 severe hypoglycemic episodes (requiring glucagon and/or assistance from another person) in the past 6 months; Body mass index <20 kg/m2; Pregnant, breast feeding, or the intention of becoming pregnant.

ClinicalTrials.gov NCT05822609