INV 202 for Diabetic Kidney Disease

Recruiting in Palo Alto (17 mi)

+72 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Inversago Pharma Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests a new drug called INV-202 in adults with Diabetic Kidney Disease caused by Type 1 or Type 2 diabetes. The goal is to see if the drug is effective, safe, and well-tolerated, and how it behaves in the body.

Eligibility Criteria

This trial is for adults with Diabetic Kidney Disease linked to Type 1 or Type 2 diabetes, who have managed their diabetes stably for at least 4 months and have an HbA1c below 9.5%. It's not for those with recent drug abuse, thyroid issues, significant psychiatric disorders, other kidney diseases (except hypertension), or those using cannabis products recently.

Inclusion Criteria

I have been diagnosed with Diabetic Kidney Disease.

Is your hemoglobin A1C (HbA1c) less than 9.5%?

I have been on a stable diabetes medication regimen for at least 4 months.

Exclusion Criteria

You have a history of severe mental health disorders such as depression, bipolar disorder or schizophrenia, or have had thoughts of suicide or attempted suicide in the past two years. If your score is 15 or higher on the PHQ-9 questionnaire, you will also be excluded.

I have had epilepsy or brain surgery in the past.

You have taken any experimental medication within the past month or within 5 half-lives of the drug, whichever is longer.

+6 more

Participant Groups

The study tests INV-202 against a placebo in treating Diabetic Kidney Disease. Participants will be randomly assigned to receive either the investigational drug INV-202 or a placebo to evaluate its effectiveness and safety.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: INV-202 25 mgExperimental Treatment1 Intervention

INV-202 25 mg Arm

Group II: INV 202 10 mgExperimental Treatment1 Intervention

INV-202 10 mg Arm

Group III: PlaceboPlacebo Group1 Intervention

Placebo Arm