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

Inclusion Criteria:

1. Male and female participants ≥18 years of age.

2. Able and willing to give informed consent and to comply with scheduled visits andtrial procedures.

3. A diagnosis of DKD due to either T1DM or T2DM (diagnosed for ≥1 year)

4. On a stable anti-diabetic medication regimen for ≥4 months prior to randomizationwith a hemoglobin A1C (HbA1c) <9.5%.

5. Participants with T1DM may not be on any glucose lowering medications beyondinsulin.

6. Participants with T2DM may be on more than 1 anti diabetic medication regimen (eg, SGLT2 inhibitor, insulin, or other anti-diabetic medication regimen).

7. HbA1c should have been performed within the last 4 months prior torandomization.

8. Participants must be on a stable dose of ACEi or ARB for ≥4 months prior torandomization and expected to remain stable for the 4-month treatment period.

9. Participants taking finerenone (not required), on a stable dose for ≥4 months priorto randomization.

10. Presence of albuminuria with a UACR >100 mg/g and <3000 mg/g at screening.

Exclusion Criteria:

1. Significant medical condition, that in the opinion of the Investigator will placethe participant at risk during the study or that will confound the study endpoints.

2. Participants not fully vaccinated for Coronavirus Disease 2019 (COVID 19).

3. Participants will be considered fully vaccinated if they have received allrecommended doses of a COVID-19 vaccine that has been authorized or approved bythe United States Food and Drug Administration (FDA) or is listed for emergencyuse by the World Health Organization within 14 days prior to the first dose ofthe study drug.

4. Participants who have fully recovered from COVID 19 and have a negativeCOVID-19 test ≥14 days before screening are eligible.

5. Other causes of kidney disease that are not DKD (eg, lupus nephritis). Of note,hypertension is not an exclusion criteria.

6. Participants with an eGFR <30 ml/min/1.73m².

7. Participants who have had acute kidney injury (AKI) within the past 3 months, orhave ever received dialysis.

8. Participants with a history of epilepsy or intracranial surgery.

9. Uncontrolled hypertension with measurements of systolic pressures >160 or diastolicmeasurements >100 at the Screening Visit.

10. Active substance abuse including inhaled or injection drugs in the year prior toscreening.

11. Use of cannabis or cannabinoid containing compounds within 90 days prior toscreening.

12. Pregnancy, planned pregnancy, potential for pregnancy or unwillingness to useeffective birth control during the trial, as well as breast feeding.

13. Evidence of moderate to severe hepatic impairment as defined by Child's-Pugh B or C.

14. Subjects with a history of significant psychiatric disorder, including but notlimited to:

15. Major depression within the last 2 years.

16. Any history of a suicide attempt or suicidal ideation.

17. Subjects with a history of other severe psychiatric disorders (eg,schizophrenia, bipolar disorder).

18. Score of the 9-question Patient Health Questionnaire (PHQ-9) ≥15 at baseline.

19. Current or active malignancy within the past 5 years, except for cancer in situ, ornon-melanoma skin cancer such as basal cell or squamous cell carcinoma that has beencompletely resected.

20. QTc >500 msec at baseline.

21. Any chronic medications started or changed within the past 3 months or at risk ofneeding to be changed during the study.

22. Participants with a history of hyperthyroidism or other thyroid diseases.

23. Participants taking a strong inducer or inhibitor of cytochrome P450 3A4, 2D6 or 2C19 by screening. These medications are prohibited during the entire studyduration.

24. Having taken any investigational compound within 30 days, or 5 half-lives of thedrug, whichever is longer, before the Screening Visit.