CIR-0602K for Type 1 Diabetes

(WBH003 Trial)

Overseen By Lee Hartline, MEd

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Virginia

Must be taking: Insulin

Must not be taking: Antihyperglycemics, Anti-inflammatories

Disqualifiers: Pregnancy, Smoking, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment, CIR-0602K, for individuals with type 1 diabetes. The goal is to determine if this drug can maintain blood sugar levels in a healthier range for longer and reduce daily insulin requirements. Researchers will compare CIR-0602K to a placebo to assess its effectiveness. This trial may suit those who have had type 1 diabetes for at least a year, use automated insulin delivery systems, and meet specific health criteria. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant diabetes research.

Will I have to stop taking my current medications?

The trial requires that you have been on a stable regimen of non-diabetic medications for the last 6 months. You cannot use any antihyperglycemic medication beyond insulin or have unstable doses of certain medications like blood pressure drugs. Daily use of anti-inflammatory medications is also not allowed.

Is there any evidence suggesting that CIR-0602K is likely to be safe for humans?

In earlier studies, more than 300 people used CIR-0602K for up to one year. The treatment was well-tolerated, and no major safety issues were reported. This suggests that CIR-0602K might be safe for humans. However, it is important to remember that all medicines can have side effects. Further research will help confirm its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for type 1 diabetes?

Most treatments for Type 1 Diabetes rely on insulin therapy to manage blood sugar levels. However, CIR-0602K is unique because it targets the underlying autoimmune process that causes the body's immune system to attack insulin-producing cells. Researchers are excited about CIR-0602K because it uses a novel mechanism to potentially halt or slow down this immune attack, offering hope for a more long-term solution rather than just managing symptoms. This could represent a significant shift in how Type 1 Diabetes is treated, moving beyond symptom management towards addressing the root cause of the disease.

What evidence suggests that CIR-0602K might be an effective treatment for type 1 diabetes?

Research has shown that CIR-0602K may help people with diabetes manage their blood sugar levels more effectively. In earlier studies, individuals with type 2 diabetes experienced a noticeable drop in their HbA1c levels, a measure of blood sugar over time, and in their insulin levels. The treatment also improved how muscles use energy, enhancing the body's insulin efficiency. This trial will evaluate CIR-0602K for people with type 1 diabetes, with some participants receiving CIR-0602K and others a placebo. These encouraging results suggest that CIR-0602K might also benefit people with type 1 diabetes by helping them maintain their blood sugar within the target range longer and reducing their daily insulin needs. ^{1 2 3 6 7}

Who Is on the Research Team?

William B. Horton, MD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for individuals with Type 1 Diabetes who may also have insulin resistance. Participants should be using a closed-loop automated insulin delivery system. The study excludes those with recent ketoacidosis, other serious health conditions, or taking medications that affect blood sugar.

Inclusion Criteria

Provision of signed and dated informed consent form

Currently utilizing closed-loop AID therapy that is compatible with Dexcom G7 CGM

All screening labs within normal limits or not clinically significant

Exclusion Criteria

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

My eye condition is more severe than mild nonproliferative retinopathy.

I have not had diabetic ketoacidosis in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline

Participants undergo baseline assessments and begin treatment

1 day

1 visit (in-person)

Treatment

Participants take either CIR-0602K or placebo, wear a CGM, and monitor ketone levels

12 weeks

Regular contact (virtual)

End-of-Study

Participants return study equipment and complete final assessments

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CIR-0602K

Trial Overview

The trial is testing CIR-0602K, a new drug aimed at improving glucose control and reducing the need for insulin in people with Type 1 Diabetes. It will be compared to a placebo to determine its effectiveness.

How Is the Trial Designed?

Group I: CIR-0602K Active Control 1 Intervention

CIR-0602K 250 mg daily

Group II: Placebo Placebo Group 1 Intervention

Matching Placebo Tablet

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07186660

NCT07186660 | Evaluation of a Novel Insulin Sensitizer in ...

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 ...

2.

breakthrought1d.org

breakthrought1d.org/for-the-media/press-releases/cirius-therapeutics-breakthrough-t1d-and-uva-health-collaborate-on-phase-2-study-of-mpc-inhibitor-cir-0602k-in-type-1-diabetes/

Cirius Therapeutics, Breakthrough T1D and UVA Health ...

If it can improve their glycemic control while also reducing insulin requirements and addressing associated metabolic dysfunction at the ...

3.

prnewswire.com

prnewswire.com/news-releases/cirius-therapeutics-breakthrough-t1d-and-uva-health-collaborate-on-phase-2-study-of-mpc-inhibitor-cir-0602k-in-type-1-diabetes-302558399.html

Cirius Therapeutics, Breakthrough T1D and UVA Health ...

"CIR-0602K has already shown significant clinical promise in patients with type 2 diabetes and other insulin-resistant conditions, and unique ...

4.

ktla.com

ktla.com/business/press-releases/cision/20251104DE15463/cir-0602k-demonstrates-synergistic-metabolic-benefit-with-tirzepatide-new-data-presented-at-obesityweek-2025

CIR-0602K Demonstrates Synergistic Metabolic Benefit ...

A pilot clinical study also showed CIR-0602K markedly reduces HbA1c, insulin levels and fat in muscle, and increases muscle metabolic function ...

5.

withpower.com

withpower.com/trial/phase-2-diabetes-mellitus-type-1-9-2025-8ae4b

CIR-0602K for Type 1 Diabetes (WBH003 Trial)

Trial Overview The trial is testing CIR-0602K, a new drug aimed at improving glucose control and reducing the need for insulin in people with Type 1 Diabetes.

6.

prnewswire.com

prnewswire.com/news-releases/cir-0602k-demonstrates-synergistic-metabolic-benefit-with-tirzepatide-new-data-presented-at-obesityweek-2025-302604443.html

CIR-0602K Demonstrates Synergistic Metabolic Benefit ...

A pilot clinical study also showed CIR-0602K markedly reduces HbA1c, insulin levels and fat in muscle, and increases muscle metabolic function ...

7.

ciriustx.com

ciriustx.com/news

News

CIR-0602K Demonstrates Synergistic Metabolic Benefit with Tirzepatide: New Data Presented at ObesityWeek 2025 ... CIR-0602K in Type 1 Diabetes. 6/20/2025. Cirius ...