Actively Recruiting

Phase 3
Age: 18Years - 49Years
All Genders
NCT05819138

Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

Led by University of Colorado, Denver · Updated on 2026-03-04

60

Participants Needed

2

Research Sites

232 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This trial plans to learn more about the effects of a medication, semaglutide, on cardiovascular function, kidney function, and insulin sensitivity in adults with type 1 diabetes. This medication has been effective in reducing cardiovascular disease and diabetic kidney disease and improving glucose control and BMI in adults with type 2 diabetes. This study aims to look at how well the medication works in people with type 1 diabetes. Semaglutide is not approved by the FDA to be used in this way. These procedures are considered to be experimental.

CONDITIONS

Official Title

Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

Who Can Participate

Age: 18Years - 49Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-49 years
  • Diagnosis of type 1 diabetes by positive antibody or clinical diagnosis with insulin requirement since diagnosis
  • Use of insulin pump or automated insulin delivery system
  • Estimated glomerular filtration rate (eGFR) of at least 45 ml/min/1.73m2
  • Stable doses of medications affecting cardiovascular and renal function (e.g., ACE inhibitors, ARBs, statins, diuretics)
  • Body mass index (BMI) between 20 and 45 kg/m2
  • Adequate contraception for females
Not Eligible

You will not qualify if you...

  • HbA1c over 9%, recent diabetic ketoacidosis (DKA), or recent hospitalization
  • Major congenital heart disease, anemia, severe non-proliferative or proliferative retinopathy
  • Personal or family history of medullary thyroid carcinoma, multiple endocrine neoplasia type 2 (MEN2), or pancreatitis
  • Current or planned pregnancy or nursing
  • Uncontrolled thyroid disease or hypertension (blood pressure ≥160/100 mm Hg despite treatment)
  • Use of non-insulin diabetes medications, insulin sensitizers, or systemic steroids in the past 3 months
  • Use of atypical antipsychotics
  • Significant systemic illness such as cancer
  • Allergy to shellfish or iodine (exclusion only for iohexol clearance procedure)
  • Contraindications to MRI or pulmonary artery hypertension procedures
  • Allergy to GLP-1 receptor agonists

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

2

University of Washington Medicine Diabetes Institute (UWMDI)

Seattle, Washington, United States, 98109

Actively Recruiting

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Research Team

K

Kyla Best

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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