NCT07186660

Evaluation of a Novel Insulin Sensitizer in People With Type 1 Diabetes

Evaluation of a Novel Insulin Sensitizer on Glycemic Control, Insulin Usage, and Cardiovascular Biomarkers in People With Type 1 Diabetes Who Use Closed-loop Automated Insulin Delivery

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if the study drug CIR-0602K will improve glucose time-in-range and/or lower total daily insulin dose in people with type 1 diabetes who are using closed-loop automated insulin delivery. Researchers will compare CIR-0602K to a placebo (a look-alike substance that contains no drug) to see if it achieves the investigational endpoints. If the study results show that the drug works to increase time-in-range and lower insulin doses, this will lead to further studies which may then make the drug available to the public.

Detailed description

Participants in the study will: * Come to the Clinical Research Unit (CRU) at UVA Medical Center for 3 visits: Screening, Baseline (Admission 1) and End-of-Study (Admission 2). * Complete various tests of cardiovascular health at each visit. * Take either an experimental drug (CIR-0602K) or placebo for 12 weeks. * Wear a study CGM with their personal insulin pump for 12 weeks. * Be given a ketone meter and strips and be asked to take a fingerstick ketone reading every morning for 12 weeks. * The study team will contact the participants regularly during the study to check their health and how they are tolerating the study drug/placebo. * Return the study CGM, ketone meter, and remaining supplies, etc. at the end of the study. * Notify the study team of any illness, injury, hypoglycemic or hyperglycemic events during the study

Conditions

• Type 1 Diabetes (T1D)
• Glycemic Control for Diabetes Mellitus
• Insulin
• Ketones
• Cardiovascular Health

Interventions

Type	Name	Description
DRUG	CIR-0602K	mitochondrial pyruvate carrier inhibitor
DRUG	Placebo	Placebo tablet

Timeline

• Start date: 2026-02-22
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2025-09-22
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study