Diabetic Kidney DiseasePhase 2RT1DNCT05822609
Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes
A Phase 2 study testing Semaglutide in people with Diabetic Kidney Disease and Type 1 Diabetes, run by University of Washington at 4 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Kidney Disease, Type 1 Diabetes
- What is being tested?
- Semaglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 5 Apr 2024to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Madeline Harbour, BA, 720-689-4751, madeline.harbour@childrenscolorado.org
Carissa Birznieks, BS, 720-689-4751, carissa.birznieks@cuanschutz.edu
- Recruiting
University of Washington
Seattle, Washington, 98104
Jesica D Baran, 425-624-7899, jbaran@uw.edu
Dori Khakpour, RDN CDE, 206-945-4954, dorik@uw.edu
- Recruiting
Providence Sacred Heart Medical Center
Spokane, Washington, 99204
Nicole Maser, MSN RN, 509-474-5313, nicole.maser@providence.org
Susan Hood, PhD CCRC, 509-474-4224, susan.hood@providence.org
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G2N2
Vesta Lai, 416-340-4800 ext. 8508, vesta.lai@uhn.ca
Cheng Xu, 416-340-4800 ext. 8508, cheng.xu@uhn.ca
About this study
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 the detailed description
A parallel-group, double-blind, placebo-controlled, randomized study will rigorously test effects of semaglutide on the kidney. Real-time continuous glucose monitoring will be used to control glycemia during study run-in (prior to randomization) and during active therapy, which investigators anticipate will lead to similar glycemic control according to treatment assignment and ability to assess effects independent of glycemia. The trial duration is 26 weeks, a period of time sufficient to gradually titrate study medications to maximum target dose (over 12 weeks) and then observe the full short-term effect of semaglutide on the kidney.
Study Aims and Hypotheses:
Aim 1: Determine the effects of semaglutide vs. placebo on kidney oxygenation in type 1 diabetes. Hypothesis 1: Semaglutide will improve kidney oxygen availability in adults with type 1 diabetes.
Aim 2: Determine the effects of semaglutide vs. placebo on urine albumin-creatinine ratio and estimated glomerular filtration rate in type 1 diabetes. Hypothesis 2: Semaglutide will lower albuminuria and slow estimated glomerular filtration rate decline in adults with type 1 diabetes.
Aim 3: Determine the glycemic effects and safety of semaglutide vs. placebo in type 1 diabetes. Hypothesis 3: Semaglutide will reduce total daily insulin dose and improve glycemic variability without increasing risk of severe hypoglycemia or diabetic ketoacidosis in adults with type 1 diabetes.
- Conditions
- Diabetic Kidney Disease, Type 1 Diabetes
- Being tested
- Semaglutide, Placebo
- Keywords
- Glucagon-like peptide-1 receptor agonist
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
1.0 mg
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Semaglutide group from 0.25mg to 1.0mg Receives: Drug: Semaglutide |
| Placebo | Placebo comparator | Placebo group Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urine albumin excretion
Measured as mean of multiple urine albumin-creatinine ratio measurements in spot urine
Measured: Baseline to 26 weeks
Secondary outcomes (5)
Change in kidney cortical relaxation rates (R2*)
Measurement of oxygenation by magnetic resonace imaging
Measured: Baseline to 26 weeks
Change in estimated glomerular filtration rate
Estimated glomerular filtration rate will be calculated from age, sex, and the serum concentrations of creatinine and cystatin C
Measured: Baseline to 26 weeks
Change in glucose time in range
Proportion of time with glucose 70-180 mg/dL measured by continuous glucose monitoring
Measured: Baseline to 26 weeks
Change in glucose coefficient of variation
Measured by continuous glucose monitoring
Measured: Baseline to 26 weeks
Change in total daily insulin dose
Mean total dose of insulin administered per day
Measured: Baseline to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start5 Apr 2024
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, University of Colorado, Denver, Providence Healthcare, University of Toronto
- Responsible party
- Principal investigator, Ian deBoer, University of Washington
- Investigators
- Ian de Boer, MD, MS, Principal investigator, University of WashingtonJessica Kendrick, MD, Principal investigator, University of Colorado Anschutz Medical Campus and Children's Hospital ColoradoDavid Cherney, PhD, MD, Principal investigator, University of TorontoIrl Hirsch, MD, Principal investigator, University of WashingtonKatherine Tuttle, MD, Principal investigator, Providence Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822609
- Sponsor's protocol ID
- STUDY00016349
- Acronym
- RT1D
- Status last verified
- May 2026
- First submitted
- 24 Mar 2023
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study team will field direct requests from other researchers to share deidentified data after completion of the trial.
Publications
Kugathasan L, Aronson Y, Sridhar VS, Ni H, Ouimet JP, Limonte CP, Sarma S, Cherney DZI. Advancing kidney protection in type 1 diabetes: insights from emerging therapies in type 2 diabetes and chronic kidney disease. Expert Rev Clin Immunol. 2025 Aug;21(8):1113-1134. doi: 10.1080/1744666X.2025.2537446. Epub 2025 Jul 24.
PubMed 40693871
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05822609
- Acronym / sponsor ID
- RT1D / STUDY00016349
- Conditions
- Diabetic Kidney Disease, Type 1 Diabetes
- Keywords
- Glucagon-like peptide-1 receptor agonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, University of Colorado, Denver, Providence Healthcare, University of Toronto
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A parallel-group, double-blind, placebo-controlled, randomized study will rigorously test effects of semaglutide on the kidney. Real-time continuous glucose monitoring will be used to control glycemia during study run-in (prior to randomization) and during active therapy, which investigators anticipate will lead to similar glycemic control according to treatment assignment and ability to assess effects independent of glycemia. The trial duration is 26 weeks, a period of time sufficient to gradually titrate study medications to maximum target dose (over 12 weeks) and then observe the full short-term effect of semaglutide on the kidney.
Study Aims and Hypotheses:
Aim 1: Determine the effects of semaglutide vs. placebo on kidney oxygenation in type 1 diabetes. Hypothesis 1: Semaglutide will improve kidney oxygen availability in adults with type 1 diabetes.
Aim 2: Determine the effects of semaglutide vs. placebo on urine albumin-creatinine ratio and estimated glomerular filtration rate in type 1 diabetes. Hypothesis 2: Semaglutide will lower albuminuria and slow estimated glomerular filtration rate decline in adults with type 1 diabetes.
Aim 3: Determine the glycemic effects and safety of semaglutide vs. placebo in type 1 diabetes. Hypothesis 3: Semaglutide will reduce total daily insulin dose and improve glycemic variability without increasing risk of severe hypoglycemia or diabetic ketoacidosis in adults with type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: SemaglutideSemaglutide group from 0.25mg to 1.0mg |
| Placebo | Placebo comparator | Other: PlaceboPlacebo group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide1.0 mg | Drug | Semaglutide |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Change in urine albumin excretion
Time frame: Baseline to 26 weeks
Measured as mean of multiple urine albumin-creatinine ratio measurements in spot urine
5 secondary outcomes
Change in kidney cortical relaxation rates (R2*)
Time frame: Baseline to 26 weeks
Change in estimated glomerular filtration rate
Time frame: Baseline to 26 weeks
Change in glucose time in range
Time frame: Baseline to 26 weeks
Change in glucose coefficient of variation
Time frame: Baseline to 26 weeks
Change in total daily insulin dose
Time frame: Baseline to 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Derived from this study: PubMed 40693871Kugathasan L, Aronson Y, Sridhar VS, Ni H, Ouimet JP, Limonte CP, Sarma S, Cherney DZI. Advancing kidney protection in type 1 diabetes: insights from emerging therapies in type 2 diabetes and chronic kidney disease. Expert Rev Clin Immunol. 2025 Aug;21(8):1113-1134. doi: 10.1080/1744666X.2025.2537446. Epub 2025 Jul 24.
- Individual participant dataSharing planned: Yes. The study team will field direct requests from other researchers to share deidentified data after completion of the trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Semaglutide in people with Diabetic Kidney Disease and Type 1 Diabetes, run by University of Washington at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ernest Ayers, MSPH (206-685-1423, ayerse@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urine albumin excretion (time frame: Baseline to 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05822609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.