Recruiting
Phase 2

Semaglutide

Sponsor:

University of Washington

Code:

NCT05822609

Conditions

Diabetic Kidney Disease

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Semaglutide

Placebo

Study Details

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.

Conditions

Diabetic Kidney Disease

Type 1 Diabetes

Study ID

NCT05822609

Start date

Apr 5, 2024

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Semaglutide

Semaglutide group from 0.25mg to 1.0mg

placebo comparator: Placebo

Placebo group

Interventions

Semaglutide

1.0 mg

Placebo

Placebo

Primary outcome measure

  • Change in urine albumin excretion [ Time Frame: Baseline to 26 weeks ]

Central Contacts and Locations

Central contacts

Ernest Ayers, MSPH

206-685-1423ayerse@uw.edu

Leila Zelnick, PhD

206-543-2981lzelnicke@uw.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Madeline Harbour, BA

720-689-4751madeline.harbour@childrenscolorado.org

Carissa Birznieks, BS

720-689-4751carissa.birznieks@cuanschutz.edu

Principal Investigator:

Jessica Kendrick, MD

University of Washington

Recruiting

Seattle, Washington, United States, 98104

Contacts

Jesica D Baran

425-624-7899jbaran@uw.edu

Dori Khakpour, RDN CDE

206-945-4954dorik@uw.edu

Principal Investigator:

Irl Hirsch, MD

Providence Sacred Heart Medical Center

Recruiting

Spokane, Washington, United States, 99204

Contacts

Nicole Maser, MSN RN

509-474-5313nicole.maser@providence.org

Susan Hood, PhD CCRC

509-474-4224susan.hood@providence.org

Principal Investigator:

Katherine Tuttle, MD

Toronto General Hospital, University Health Network

Recruiting

Toronto, Ontario, Canada, M5G2N2

Contacts

Vesta Lai

416-340-4800vesta.lai@uhn.ca

Cheng Xu

416-340-4800cheng.xu@uhn.ca

Principal Investigator:

David Cherney, MD CM PhD

More Information

Sponsor

University of Washington

Last update posted

Jun 2, 2026

Last verified

May, 2026

Keywords

  • Glucagon-like peptide-1 receptor agonist

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Washington on 2026-06-02.