Recruiting
Phase 2

CIR-0602K

Sponsor:

University of Virginia

Code:

NCT07186660

Conditions

Type 1 Diabetes (T1D)

Glycemic Control for Diabetes Mellitus

Insulin

Ketones

Cardiovascular Health

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

CIR-0602K

Placebo

Study Details

Brief 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.

Conditions

Type 1 Diabetes (T1D)

Glycemic Control for Diabetes Mellitus

Insulin

Ketones

Cardiovascular Health

Study ID

NCT07186660

Start date

Feb 22, 2026

Status verified date

Feb, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. History of type 1 diabetes for at least one year
4. Age 18-45 years
5. 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: CIR-0602K

CIR-0602K 250 mg daily

placebo comparator: Placebo

Matching Placebo Tablet

Interventions

CIR-0602K

mitochondrial pyruvate carrier inhibitor

Placebo

Placebo tablet

Primary outcome measure

  • Glucose Time-in-Range [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

More Information

Sponsor

University of Virginia

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Keywords

  • Type 1 Diabetes
  • closed loop technology
  • time-in-range
  • adjunct therapy
  • cardiovascular health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-02-25.