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Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

This study is looking at how a medication called semaglutide affects heart health, kidney function, and how your body uses insulin in adults with type 1 diabetes. Semaglutide has already shown benefits for people with type 2 diabetes, but it's not yet approved for type 1 diabetes. You might be able to join if you are 18-49 years old, have type 1 diabetes, use an insulin pump or automated insulin delivery system, and have healthy kidney function (eGFR ≥ 45 ml/min/1.73m2). Researchers will measure changes in your artery stiffness (pulse wave velocity) to see if semaglutide helps. This study is currently recruiting 60 participants.

Study design
This is an interventional study, meaning participants will receive either semaglutide or a placebo. The study aims to enroll 60 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your artery stiffness will be measured at the beginning of the study and again at month 8.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05819138

Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

Recruiting
PHASE3Ages 18–49InterventionalTreatment
University of Colorado, Denver
~60 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:Semaglutide Pen InjectorPlacebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Ascending Aortic Pulse Wave Velocity (AA PWV)
Measured over Baseline, month 8
+2 more outcomes measured

Conditions

Diabetes Mellitus, Type 1

Explore related trials

Type 1 Diabetes Mellitus

Where it's being run

2 sites across 2 states
Colorado1
Washington1

Study leadership

  • Petter M Bjornstad, MD · PRINCIPAL_INVESTIGATOR · University of Washington
  • Kristen Nadeau, MD, MS · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

Kyla Best
[email protected]
720-777-9500
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Age 18-49 years
1\) T1D diagnosis defined as positive T1D-associated antibody(ies) or 2) a clinical diagnosis of T1D plus insulin requirement since diagnosis
Insulin pump or automated insulin delivery systems
Estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73m2
Stable doses of drugs altering cardiovascular and renal function (e.g., Angiotensin-Converting Enzyme Inhibitor (ACEi), Angiotensin Receptor Blocker (ARB), statins, diuretics)
BMI 20-45 kg/m2
Adequate contraceptive method for females

Exclusion

HbA1c \>9%, recent diabetic ketoacidosis (DKA) or hospitalization
Major congenital heart disease, anemia, severe non-proliferative retinopathy, proliferative retinopathy
History/family history of medullary thyroid carcinoma, multiple endocrine neoplasia type 2 (MEN2), pancreatitis
Current/planned pregnancy or nursing
Uncontrolled thyroid disease or hypertension (HTN) (≥ 160/100 mm Hg despite optimal therapy)
Use of other non-insulin diabetes medications, insulin sensitizing medications, or systemic steroids in past 3 months
Use of atypical antipsychotics
Significant systemic illness such as cancer
Shellfish/iodine allergy (only exclusionary to iohexol clearance procedure)
MRI or PAH contraindications (only exclusionary to MRI and PAH procedures), GLP-1RA allergy

What this trial measures

  • Change in Ascending Aortic Pulse Wave Velocity (AA PWV)Baseline, month 8

    AA PWV is a measure of central arterial stiffness. A lower value indicates a better outcome.

  • Change in Carotid and Femoral Artery Pulse Wave Velocity (CF-PWV)Baseline, month 8

    CF-PWV is a measure of peripheral arterial stiffness. A lower value indicates a better outcome.

  • Change in Carotid and Radial Artery Pulse Wave Velocity (CR-PWV)Baseline, month 8

    CR-PWV is a measure of peripheral arterial stiffness. A lower value indicates a better outcome.