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Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes

This study is testing Semaglutide, a medication, to see if it can help adults with type 1 diabetes who also have diabetic kidney disease. Researchers want to find out if Semaglutide can reduce the amount of a protein called albumin in your urine (pee), which is a sign of kidney damage. They will also look at how Semaglutide affects your kidney function and safety. You might be able to join if you are an adult (18 or older) with type 1 diabetes for at least 5 years, have a certain level of protein in your urine, and your kidneys are working at a specific level. The study aims to see if Semaglutide can improve kidney health over 26 weeks.

Study design
This is a randomized, double-blind study where 60 participants will receive either Semaglutide or a placebo (an inactive substance). This means neither you nor your doctor will know which treatment you are getting.
What's involved
You would participate in the study for 26 weeks, during which study medications will be gradually increased over 12 weeks. Continuous glucose monitoring will be used throughout the study.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 26 weeks, which is the duration of the active treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05822609

Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Washington
~60 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:SemaglutidePlacebo

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in urine albumin excretion
Measured over Baseline to 26 weeks

Conditions

Diabetic Kidney Disease
Type 1 Diabetes

Explore related trials

Diabetic NephropathyType 1 Diabetes Mellitus

Where it's being run

4 sites across 3 states
Washington2
Colorado1
Ontario1

Study leadership

  • Ian de Boer, MD, MS · PRINCIPAL_INVESTIGATOR · University of Washington
  • Jessica Kendrick, MD · PRINCIPAL_INVESTIGATOR · University of Colorado Anschutz Medical Campus and Children's Hospital Colorado
  • David Cherney, PhD, MD · PRINCIPAL_INVESTIGATOR · University of Toronto
  • Irl Hirsch, MD · PRINCIPAL_INVESTIGATOR · University of Washington
  • Katherine Tuttle, MD · PRINCIPAL_INVESTIGATOR · Providence Healthcare

Who to contact

Ernest Ayers, MSPH
[email protected]
206-685-1423
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

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

What this trial measures

  • Change in urine albumin excretionBaseline to 26 weeks

    Measured as mean of multiple urine albumin-creatinine ratio measurements in spot urine