Type 1 Diabetes (T1D)Phase 2WBH003NCT07186660
Evaluation of a Novel Insulin Sensitizer in People With Type 1 Diabetes
A Phase 2 study testing CIR-0602K in people with Type 1 Diabetes (T1D) and Glycemic Control for Diabetes Mellitus, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Type 1 Diabetes (T1D), Glycemic Control for Diabetes Mellitus, Insulin
- What is being tested?
- CIR-0602K
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2026to Sep 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- History of type 1 diabetes for at least one year
- Age 18-45 years
- HbA1c <10%
- BMI 18-35 kg/m2. Within this criterion, participants must have either BMI ≥25 or total daily insulin dose of ≥0.5 units/kg/day.
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- Currently utilizing closed-loop AID therapy that is compatible with Dexcom G7 CGM.
- On stable regimen of non-diabetic medications for the last 6 months.
- All screening labs within normal limits or not clinically significant.
- Ability to take oral medication and be willing to adhere to the study drug/placebo for 12 weeks.
- For females and males of reproductive potential: agreement to use adequate contraception during study participation and for an additional 2 weeks after the end of CIR-0602K administration.
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study intervention.
- Agreement to adhere to Lifestyle Considerations throughout study duration.
Who cannot join
- Current Pregnancy or currently breastfeeding.
- History of smoking tobacco products within the last two years.
- History of alcohol abuse or illicit drug abuse within 6 months of screening.
- Known history of human immunodeficiency virus (HIV).
- History of other significant disease (e.g., cardiac, cerebrovascular, gastrointestinal, liver, renal, or endocrine) that could, in the investigator's view, alter study outcomes
- Any surgical or medical condition which may significantly alter the absorption of the study drug including but not limited to the following: history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling, or gastric banding, currently active inflammatory bowel syndrome.
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- Current use of any antihyperglycemic medication beyond insulin (i.e., GLP-1 receptor agonists, SGLT2 inhibitors, etc.).
- Unstable doses (i.e., dose change within the last 4 months) of vasoactive medications (e.g., calcium-channel blockers, statins, angiotensin-converting enzyme inhibitors, diuretics, nitrates, alpha-blockers, beta-blockers, etc.).
- Daily use of anti-inflammatory medications (e.g., ibuprofen, aspirin, prednisone, dexamethasone, etc.).
- Diagnosis of peripheral neuropathy (assessed by screening monofilament exam).
- Macroalbuminuria (i.e., urine albumin: creatinine >300 mg per g).
- Retinopathy beyond mild, nonproliferative retinopathy.
- History of Level 3 hypoglycemia within the last 12 months.
- History of diabetic ketoacidosis (DKA) within the last 12 months.
- Screening electrocardiogram (ECG) findings indicative of arrhythmia, sinus node disease, or ischemic heart disease.
- Screening oxygen saturation <90%
- History of hypersensitivity or prior adverse reaction to the study drug, closely-related compounds, or any of the stated ingredients.
- Use of concomitant medications with a known significant metabolism by CYP2C8 or CYP2C (including paclitaxel, phenytoin, warfarin, celecoxib, tolbutamide, or repaglinide) for the duration of the study.
- Participation in an investigational study (other than a non-treatment registry study) or received an investigational drug withing 30 days or 5 half-lives (whichever is longer) prior to randomization.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Horton B Horton, MD, (434) 924-1828, WBH2N@VIRGINIA.EDU
About this study
Official title: 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
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.
Read the 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
- Being tested
- CIR-0602K, Placebo
- Keywords
- Type 1 Diabetes, closed loop technology, time-in-range, adjunct therapy, cardiovascular health
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIR-0602KDrug
mitochondrial pyruvate carrier inhibitor
PlaceboDrug
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| CIR-0602K | Active comparator | CIR-0602K 250 mg daily Receives: Drug: CIR-0602K |
| Placebo | Placebo comparator | Matching Placebo Tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Time-in-Range
Glucose time 70-180 mg/dL
Measured: 12 weeks
Secondary outcomes (5)
Total Daily Insulin Dose
Units of insulin per day
Measured: 12 weeks
Glucose Time-above-Range
Glucose time >180 mg/dL
Measured: 12 weeks
Glucose Time-Below-Range
Glucose time <70 mg/dL
Measured: 12 weeks
Hemoglobin A1c
measure of glycemic control
Measured: 12 weeks
Insulin Sensitivity
M-value from euglycemic insulin clamp
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start22 Feb 2026
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Horton, MD, University of Virginia
- Investigators
- William B. Horton, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186660
- Sponsor's protocol ID
- 302645
- Other IDs
- 3-SRA-2025-1773-M-B
- Acronym
- WBH003
- Status last verified
- Feb 2026
- First submitted
- 12 Sep 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigative team will finalize the decision (as to whether or not to share IPD) at a later date. Of note, IPD in this study qualifies as protected health information and would thus require safety considerations.