Phase 2 Study of INV-202 in Patients With Diabetic Kidney Disease

Exclusion Criteria

• •1. Significant medical condition, that in the opinion of the Investigator will place the participant at risk during the study or that will confound the study endpoints.
• •2. Participants not fully vaccinated for Coronavirus Disease 2019 (COVID 19).
• •1. Participants will be considered fully vaccinated if they have received all recommended doses of a COVID-19 vaccine that has been authorized or approved by the United States Food and Drug Administration (FDA) or is listed for emergency use by the World Health Organization within 14 days prior to the first dose of the study drug.
• •2. Participants who have fully recovered from COVID 19 and have a negative COVID-19 test ≥14 days before screening are eligible.
• •4. Participants with an eGFR \<30 ml/min/1.73m².
• •5. Participants who have had acute kidney injury (AKI) within the past 3 months, or have ever received dialysis.
• •6. Participants with a history of epilepsy or intracranial surgery.
• •7. Uncontrolled hypertension with measurements of systolic pressures \>160 or diastolic measurements \>100 at the Screening Visit.
• •8. Active substance abuse including inhaled or injection drugs in the year prior to screening.
• •9. Use of cannabis or cannabinoid containing compounds within 90 days prior to screening.
• •10. Pregnancy, planned pregnancy, potential for pregnancy or unwillingness to use effective birth control during the trial, as well as breast feeding.
• •11. Evidence of moderate to severe hepatic impairment as defined by Child's-Pugh B or C.
• •12. Subjects with a history of significant psychiatric disorder, including but not limited to:
• •1. Major depression within the last 2 years.
• •2. Any history of a suicide attempt or suicidal ideation.
• •3. Subjects with a history of other severe psychiatric disorders (eg, schizophrenia, bipolar disorder).
• •13. Score of the 9-question Patient Health Questionnaire (PHQ-9) ≥15 at baseline.
• •14. Current or active malignancy within the past 5 years, except for cancer in situ, or non-melanoma skin cancer such as basal cell or squamous cell carcinoma that has been completely resected.
• •15. QTc \>500 msec at baseline.
• •16. Any chronic medications started or changed within the past 3 months or at risk of needing to be changed during the study.
• •17. Participants with a history of hyperthyroidism or other thyroid diseases.
• •18. Participants taking a strong inducer or inhibitor of cytochrome P450 3A4, 2D6 or 2C19 by screening. These medications are prohibited during the entire study duration.
• •19. Having taken any investigational compound within 30 days, or 5 half-lives of the drug, whichever is longer, before the Screening Visit.