NCT06338553 GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab
| NCT ID | NCT06338553 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-06-12 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2024-06-12 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Aims 1-3: Stage 2 T1DM with TZIELD® and GLP-1Ra Inclusion Criteria: * Age: 12-50 years * BMI: 18-31 kg/m2 (adults) or 5-95th %ile (pediatric) * Stage 2 T1DM (i.e., ≥ 2 islet auto-antibodies and: * fasting glucose ≥ 100 mg/dL and \< 126 mg/dL OR * 2-hr OGTT /MMTT ≥ 140 mg/dL and \< 200 mg/dL OR * During an OGTT having a glucose of \> 199 mg/dL at 30, 60, or 90 minutes) Exclusion Criteria: * Comorbidities: * SBP \> 140 mmHg and DBP \> 100 mmHg * eGFR by MDRD equation of \< 60 mL/min/1.73m2 * AST or ALT \> 2.5 times ULN * Family history of medullary thyroid carcinoma * Diagnosis of pancreatitis or gastroparesis within the past 3 years * Medications: Any diabetes medication, any antioxidant vitamin supplement (\<2 weeks before a study), any systemic glucocorticoid, antipsychotic, atenolol, metoprolol, propranolol, niacin, any thiazide diuretic, any OCP with \> 35 mcg ethinyl estradiol, growth hormone, any immunosuppressant, antihypertensive, any antihyperlipidemic * Other: pregnancy, peri- or post-menopausal women, active smoker Aim 4: Early Stage 3 T1DM with GLP-1Ra Monotherapy Inclusion Criteria * Age: 12-50 years * BMI: 18-31 kg/m2 (adults) or 5-95th %ile (pediatric) * Early stage 3 T1DM with either * HbA1c 6.5% to 8.0% at diagnosis OR * HbA1c 5.7% to 6.4% with oral glucose test meeting ADA criteria for stage 3 T1DM within the past three months prior to or during screening visit * Time of stage 3 diagnosis: within eight weeks of first study visit Exclusion Criteria * DKA history: history of diabetic ketoacidosis requiring hospital admission * Comorbidities: * Family history of medullary thyroid carcinoma * Diagnosis of pancreatitis or gastroparesis within the past 3 years * Medications: Any diabetes medication, any antioxidant vitamin supplement (\<2 weeks before a study), any systemic glucocorticoid, antipsychotic, atenolol, metoprolol, propranolol, niacin, any thiazide diuretic, any OCP with \> 35 mcg ethinyl estradiol, growth hormone, any immunosuppressant, antihypertensive, any antihyperlipidemic * Other: pregnancy, peri- or post-menopausal women, active smoker
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06338553 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 50 Years, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06338553 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06338553 currently recruiting?
Yes, NCT06338553 is actively recruiting participants. Contact the research team at metabolism@vumc.org for enrollment information.
Where is the NCT06338553 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT06338553 clinical trial?
NCT06338553 is sponsored by Vanderbilt University Medical Center. The trial plans to enroll 24 participants.
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