Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes

NCT05822609 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY00016349
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 4

Brief Summary

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.

Conditions

Diabetic Kidney Disease; Type 1 Diabetes

Keywords

Glucagon-like peptide-1 receptor agonist

Outcome Measures

Primary Outcomes (1)

• Change in kidney cortical relaxation rates (R2*)

  Measurement of oxygenation by magnetic resonance imaging

  Baseline to 26 weeks

Secondary Outcomes (5)

• Change in urine albumin excretion

  Baseline to 26 weeks

• Change in estimated glomerular filtration rate

  Baseline to 26 weeks

• Change in glucose time in range

  Baseline to 26 weeks

• Change in glucose coefficient of variation

  Baseline to 26 weeks

• Change in total daily insulin dose

  Baseline to 26 weeks

Study Arms (2)

Semaglutide

EXPERIMENTAL

Semaglutide group from 0.25mg to 1.0mg

Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

Placebo group

Other: Placebo

Interventions

Semaglutide DRUG

1.0 mg

Semaglutide

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≥ 30 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Juvenile Diabetes Research Foundation: collaborator
• University of Colorado, Denver: collaborator
• Providence Healthcare: collaborator
• University of Toronto: collaborator

Study Sites (4)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

University of Washington

Seattle, Washington, 98104, United States

RECRUITING

Providence Sacred Heart Medical Center

Spokane, Washington, 99204, United States

RECRUITING

Toronto General Hospital, University Health Network

Toronto, Ontario, M5G2N2, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 40693871 DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus, Type 1

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ian de Boer, MD, MS

  University of Washington

  PRINCIPAL INVESTIGATOR

• Jessica Kendrick, MD

  University of Colorado Anschutz Medical Campus and Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

• David Cherney, PhD, MD

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Irl Hirsch, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Katherine Tuttle, MD

  Providence Healthcare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ernest Ayers, MSPH

CONTACT

206-685-1423; ayerse@uw.edu

Leila Zelnick, PhD

CONTACT

206-543-2981; lzelnicke@uw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 21, 2023
• Study Start: April 5, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (3); CA (1)