NCT05822609 · University of Washington
Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes
(RT1D)
What this study is about
The primary objective of this study is to determine the effects of semaglutide on kidney oxygenation and function in type 1 diabetes. The secondary objective is to determine the glycemic effects and safety of semaglutide in type 1 diabetes.
View original scientific description
The primary objective of this study is to determine the effects of semaglutide on kidney oxygenation and function in type 1 diabetes. The secondary objective is to determine the glycemic effects and safety of semaglutide in type 1 diabetes.
Interventions
DRUG
Semaglutide
1.0 mg
OTHER
Placebo
Placebo
Primary outcome measures
Change in urine albumin excretion
Time frame: Baseline to 26 weeks
Measured as mean of multiple urine albumin-creatinine ratio measurements in spot urine
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Aurora, Colorado
- Seattle, Washington
- Spokane, Washington
Collaborators
Juvenile Diabetes Research Foundation, University of Colorado, Denver, Providence Healthcare, University of Toronto
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations