Recruiting
Phase 3

Semaglutide

Sponsor:

University of Colorado, Denver

Code:

NCT05819138

Conditions

Diabetes Mellitus, Type 1

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Not accepted

Interventions

Semaglutide Pen Injector

Placebo

Study Details

Brief summary:

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

Diabetes Mellitus, Type 1

Study ID

NCT05819138

Start date

Jun 21, 2023

Status verified date

Mar, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Semaglutide

Participants will receive 0.25 mg once weekly semaglutide injection for 4 weeks.

Participants will receive 0.50 mg once weekly semaglutide injection for 4 weeks.

Participants will receive 1.0 mg once weekly semaglutide injection for 6 months.

placebo comparator: Placebo

Participants will receive 0.25 mg once weekly placebo injection for 4 weeks. Participants will receive 0.50 mg once weekly placebo injection for 4 weeks. Participants will receive 1.0 mg once weekly placebo injection for 6 months.

Interventions

Semaglutide Pen Injector

Semaglutide injection

Placebo

Semaglutide placebo injection

Primary outcome measure

  • Change in Ascending Aortic Pulse Wave Velocity (AA PWV) [ Time Frame: Baseline, month 8 ]
  • Change in Carotid and Femoral Artery Pulse Wave Velocity (CF-PWV) [ Time Frame: Baseline, month 8 ]
  • Change in Carotid and Radial Artery Pulse Wave Velocity (CR-PWV) [ Time Frame: Baseline, month 8 ]

Central Contacts and Locations

Central contacts

Kyla Best

720-777-9500Kyla.Best@cuanschutz.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Kyla Best

720-777-9500Kyla.Best@cuanschutz.edu

Principal Investigator:

Kristen Nadeau, MD, MS

University of Washington Medicine Diabetes Institute (UWMDI)

Recruiting

Seattle, Washington, United States, 98109

Contacts

Amanda Bard

504-521-7822abard@uw.edu

Principal Investigator:

Petter Bjornstad, M.D.

More Information

Sponsor

University of Colorado, Denver

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-03-04.