GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab

NCT06338553 · Recruiting

Last updated 2026-05-28

This clinical trial is testing whether a GLP-1 receptor agonist can help manage blood sugar levels after meals in adults with early-stage type 1 diabetes who are also receiving teplizumab.

Status Recruiting Currently enrolling participants.

Phase Early Phase 1 First exploratory testing in people.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind basic-science study

Participants 24 people Planned (estimated).

Who can join Ages 12–50 · all sexes

Timeline Started 2024-06 · est. completion 2027-03

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT06338553 ↗

Description as written by the study sponsor.

The goal of this study is to determine how a drug class called glucagon-like peptide-1 receptor agonists (GLP-1Ra) affects people during an early stage of Type 1 Diabetes undergoing clinical teplizumab treatment. This study involves giving participants a liquid meal under different conditions and observing how their bodies respond, focusing on blood sugar levels, insulin effectiveness, and blood vessel function. The meal tests are followed by two post-treatment tests, one with the GLP-1Ra drug and the other with a placebo. Each test involves blood draws before and during the meal test, GLP-1Ra or placebo administration, and an ultrasound to measure blood vessel function. The goal is to see if GLP-1Ra can help manage blood sugar levels and improve cardiovascular health in this population.

Treatments tested

Semaglutide (Rybelsus®) Drug

7 mg single dose of Rybelsus® by mouth once before each MMTT
Placebo Drug

placebo capsule or tablet once before each MMTT.

Main thing measured	Investigate the impact of GLP-1Ra on postprandial glycemia in a pilot study
Sponsor	Vanderbilt University Medical Center
Conditions studied	Type 1 Diabetes
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06338553 ↗