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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07186660
- Acronym / sponsor ID
- WBH003 / 302645
- Conditions
- Type 1 Diabetes (T1D), Glycemic Control for Diabetes Mellitus, Insulin, Ketones, Cardiovascular Health
- Keywords
- Type 1 Diabetes, closed loop technology, time-in-range, adjunct therapy, cardiovascular health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 22 Feb 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIR-0602K | Active comparator | Drug: CIR-0602KCIR-0602K 250 mg daily |
| Placebo | Placebo comparator | Drug: PlaceboMatching Placebo Tablet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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%
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CIR-0602Kmitochondrial pyruvate carrier inhibitor | Drug | CIR-0602K |
| PlaceboPlacebo tablet | Drug | Placebo |
Primary outcome
Glucose Time-in-Range
Time frame: 12 weeks
Glucose time 70-180 mg/dL
5 secondary outcomes
Total Daily Insulin Dose
Time frame: 12 weeks
Glucose Time-above-Range
Time frame: 12 weeks
Glucose Time-Below-Range
Time frame: 12 weeks
Hemoglobin A1c
Time frame: 12 weeks
Insulin Sensitivity
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William B. Horton, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lee Hartline, MEd (14349245247, LMH9D@VIRGINIA.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose Time-in-Range (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.