NCT05822609 Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes
| NCT ID | NCT05822609 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Washington |
| Condition | Diabetic Kidney Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-04-05 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2024-04-05 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * HbA1c \>9%, recent diabetic ketoacidosis, hyperosmolar hyperglycemic state or severe illness requiring hospitalization in past 30 days * 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 * Current/planned pregnancy or nursing * Uncontrolled thyroid disease or hypertension (Systolic blood pressure \[SBP\] ≥ 160 mm Hg or diastolic blood pressure \[DBP\] ≥ 100 mm Hg despite treatment) * 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 * Frequent hypoglycemia during the last two weeks of the study run-in phase (time below range \[\<70 mg/dL\] ≥4%) * 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 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 * Body mass index \<20 kg/m2 * Known or suspected allergy/sensitivity to semaglutide or its excipients * Pregnant, breast feeding, or the intention of becoming pregnant * The receipt of any investigational drug within 3 months prior to this trial * Previously randomized in this trial
Contact & Investigator
Ian de Boer, MD, MS
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT05822609 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetic Kidney Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05822609 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05822609 currently recruiting?
Yes, NCT05822609 is actively recruiting participants. Contact the research team at ayerse@uw.edu for enrollment information.
Where is the NCT05822609 trial being conducted?
This trial is being conducted at Aurora, United States, Seattle, United States, Spokane, United States, Toronto, Canada.
Who is sponsoring the NCT05822609 clinical trial?
NCT05822609 is sponsored by University of Washington. The principal investigator is Ian de Boer, MD, MS at University of Washington. The trial plans to enroll 60 participants.
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