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RT1D

RecruitingPhase 2

Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes

Lead sponsor

University of Washington

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Chronic kidney disease, Type 1 diabetes

Key I/E criteria

•eGFR ≥20•UACR ≥30

Primary endpoint

•Kidney cortical relaxation rates (R2*)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05822609

Org study IDSTUDY00016349

Timeline

Milestones

Study first posted2023-04-21actual

Study start2024-04-05actual

Last update posted2026-06-02actual

Primary completion2027-06estimated (month precision)

Study completion2027-12estimated (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Chronic kidney diseaseType 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot 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

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Renal / kidney

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Change in glucose time in range

Time frame:Baseline to 26 weeks

CGM time-in-range