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

Phase 2

Completed

• Conditions: Diabetic Kidney Disease
• Interventions: Drug: INV-202; Drug: Placebo

• Registration Number: NCT05514548
• Lead Sponsor: Inversago Pharma Inc.

Brief Summary

The study is designed to assess the efficacy, safety, tolerability, and transformation within the human body of INV-202 investigational drug in the treatment of adult participants with a diagnosis of Diabetic Kidney Disease due to either Type 1 diabetes mellitus or Type 2 diabetes mellitus.

Detailed Description

This is a Phase 2, randomized, double-blind, placebo controlled, dose ranging, multicenter study designed to assess the efficacy, safety, tolerability, and pharmacokinetics of INV-202 for the treatment of adult participants with a diagnosis of DKD due to either Type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM) (diagnosed ≥1 year) who are on a stable anti diabetic medication regimen for ≥4 months prior with a HbA1c \<9.5%. Approximately 240 participants (80/arm) will be randomized to 1 of 3 treatment arms in a 1:1:1 ratio: INV 202 10 mg, INV-202 25 mg, or placebo. The assigned study treatment will be taken once daily (QD), for 16 weeks.

Due to the high expected screen failure rates, participants may be pre-screened at sites with an approved pre-screening ICF.

Each participant will be allowed 1 retest during the screening period if they fail screening and 1 re-screening on a case by case basis with approval from the Worldwide medical monitors.

Study participation will last approximately 22 weeks and includes a Screening Period (up to 4 weeks), a Study Treatment Period with 16 weeks of daily study treatment, and a Safety Follow-Up Visit consisting of a phone call 2 weeks after the End of Treatment Visit (Week \[W\]18) to allow reporting of any adverse events following withdrawal of the study drug.

Any participant who withdraws before completing treatment will be requested to return for an Early Termination Visit, at which time the procedures normally scheduled for the W16 visit will be conducted.

Study Timeline

• Study First Submitted: 2022-08-18
• Study First Submitted QC: 2022-08-22
• Study First Posted: 2022-08-24
• Study Start: 2022-10-19
• Primary Completion: 2024-08-20
• Study Completion: 2024-09-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 265

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 and trial 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 randomization with a hemoglobin A1C (HbA1c) <9.5%.

   1. Participants with T1DM may not be on any glucose lowering medications beyond insulin.
   2. Participants with T2DM may be on more than 1 anti diabetic medication regimen (eg, SGLT2 inhibitor, insulin, or other anti-diabetic medication regimen).
   3. HbA1c should have been performed within the last 4 months prior to randomization.

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

6. Participants taking finerenone (not required), on a stable dose for ≥4 months prior to randomization.

7. 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 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.

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INV-202 25 mg	INV-202	INV-202 25 mg Arm
Placebo	Placebo	Placebo Arm
INV 202 10 mg	INV-202	INV-202 10 mg Arm

Primary Outcome Measures

Name	Time	Method
Change in UACR from baseline to W16	16 weeks	Measure of UACR at W16 in comparison to baseline to evaluate the effect of INV-202 in participants with diabetic kidney disease (DKD)

Secondary Outcome Measures

Name	Time	Method
Change in urine protein to creatinine ratio (UPCR) from baseline to W16	16 weeks	Measure of UPCR at W16 in comparison to baseline to evaluate the effect of INV-202 in participants with diabetic kidney disease (DKD)
Change in eGFR using cystatin C and the CKD-EPI formula from baseline to W16	16 weeks	Measure of eGFR using cystatin C and CKD-EPI formula at W16 in comparison to baseline to evaluate the effect of INV-202 in participants with diabetic kidney disease (DKD)
Change in eGFR using serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula from baseline to W16	16 weeks	Measure of eGFR using creatinine and CKD-EPI formula at W16 in comparison to baseline to evaluate the effect of INV-202 in participants with diabetic kidney disease (DKD)

Trial Locations

Locations (70)

Palm Research Center, Inc; 🇺🇸 Las Vegas, Nevada, United States

Rambam Health Care Campus \ Rambam Medical Center; 🇮🇱 Haifa, Israel

Barzilai Medical Center; 🇮🇱 Ashkelon, Israel

Ziv Medical Center - Endocrinology Clinic; 🇮🇱 Safed, Israel

Health Center Zajecar; 🇷🇸 Zaječar, Serbia

St Lucas Clinical Research Center SA de CV; 🇲🇽 Mérida, Mexico

Archangel St Michael Multiprofile Clinical Hospital Ltd; 🇬🇪 Tbilisi, Georgia

Rabin Medical Center, Beilinson Campus; 🇮🇱 Petah tikva, Israel

South Carolina Clinical Research LLC; 🇺🇸 Orangeburg, South Carolina, United States

University Clinical Center of Vojvodina; 🇷🇸 Novi Sad, Serbia

Healt Center Uzice,General Hospital; 🇷🇸 Užice, Serbia

National Institute of Clinical Research, Inc.; 🇺🇸 Garden Grove, California, United States

National Institute of Clinical Research, Inc - Upland; 🇺🇸 Upland, California, United States

Research Physicians Network Alliance; 🇺🇸 Boca Raton, Florida, United States

National Institute of Clinical Research, Inc - Pomona; 🇺🇸 Pomona, California, United States

Central Coast Nephrology; 🇺🇸 Salinas, California, United States

Endocrine Research Solutions, Inc.; 🇺🇸 Roswell, Georgia, United States

ALL Medical Research, LLC; 🇺🇸 Cooper City, Florida, United States

North American Research Institute; 🇺🇸 San Dimas, California, United States

South Florida Research Institute; 🇺🇸 Lauderdale Lakes, Florida, United States

Endocrine and metabolic Consultants; 🇺🇸 Rockville, Maryland, United States

Research by Design, LLC; 🇺🇸 Chicago, Illinois, United States

Clinical Research Consultants, LLC; 🇺🇸 Kansas City, Missouri, United States

Physicians East, PA; 🇺🇸 Greenville, North Carolina, United States

Northeast Clinical Research Center; 🇺🇸 Bethlehem, Pennsylvania, United States

Knoxville Kidney Center, Pllc; 🇺🇸 Knoxville, Tennessee, United States

Linq Research, LLC; 🇺🇸 Pearland, Texas, United States

North Texas Endocrine Center; 🇺🇸 Dallas, Texas, United States

GCP Research; 🇨🇦 Montreal, Quebec, Canada

Biopharma Informatic, LLC; 🇺🇸 Houston, Texas, United States

Clinical Advancement Center, PLLC; 🇺🇸 San Antonio, Texas, United States

Centre de recherche Clinique de Laval; 🇨🇦 Laval, Quebec, Canada

University of Vermont Medical Center; 🇺🇸 Burlington, Vermont, United States

L. Managadze National Center of Urology, LTD; 🇬🇪 Tbilisi, Georgia

"Clinic- LJ", LTD; 🇬🇪 Kutaisi, Georgia

LTD Clinic Rustavi; 🇬🇪 Rust'avi, Georgia

Acad. G. Chapidze Emergency Cardiology Center LTD, Department of Multi-center Clinical Trials; 🇬🇪 Tbilisi, Georgia

Acad. G. Chapidze Emergency Cardiology Center LTD, Department of Internal Medicine and Medical Research; 🇬🇪 Tbilisi, Georgia

Ltd "Institute of Clinical Cardiology"; 🇬🇪 Tbilisi, Georgia

LTD Tbilisi Heart Center; 🇬🇪 Tbilisi, Georgia

Aleksandre Aladashvili Clinic LLC; 🇬🇪 Tbilisi, Georgia

Israel-Georgia Research Clinic Helsicore, LTD; 🇬🇪 Tbilisi, Georgia

University of Debrecen; 🇭🇺 Debrecen, Hungary

Medifarma-98 Kft; 🇭🇺 Nyíregyháza, Hungary

National Institute of Endocrinology, LTD,; 🇬🇪 Tbilisi, Georgia

LTD "Adapt"; 🇬🇪 Tbilisi, Georgia

Diaverum Dialysis Centre of Baja and Nephrology Out-Patient Clinic of Baja St.Rokus Hospital; 🇭🇺 Baja, Hungary

Instituto de Diabetes Obesidad Y Nutricion , S.C.; 🇲🇽 Cuernavaca, Mexico

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel

Meir Medical Center; 🇮🇱 Kfar Saba, Israel

Ziv Medical Center; 🇮🇱 Safed, Israel

Centro de Investigación Médica y Reumatología S.C.; 🇲🇽 Guadalajara, Mexico

Cento de Investigacion Medica de Occidente, S.C.; 🇲🇽 Guadalajara, Mexico

Medical Office; 🇲🇽 Guadalajara, Mexico

Instituto Veracruzano en Investigacion Clínica S.C.; 🇲🇽 Veracruz, Mexico

Unidad de Investigación Clinica y atencion Medica HEPA; 🇲🇽 Guadalajara, Mexico

Clinica Integral del Paciente Diabético y Obeso; 🇲🇽 Mexico City, Mexico

Investigación Médica; 🇲🇽 Mérida, Mexico

Clinical Hospital Center Zemun; 🇷🇸 Belgrade, Serbia

University Clinical Center Nis, Clinic of Nephrology; 🇷🇸 Niš, Serbia

University Clincial Center of Serbia; 🇷🇸 Belgrade, Serbia

General Hospital "Vršac"; 🇷🇸 Belgrade, Serbia

University of Kragujevac - Klinicki Centar "Kragujevac"; 🇷🇸 Kragujevac, Serbia

General Hospital Krusevac; 🇷🇸 Kruševac, Serbia

Tbilisi Heart and Vascular Clinic LTD; 🇬🇪 Tbilisi, Georgia

Georgian Dutch Hospital LLC; 🇬🇪 Tbilisi, Georgia

DPC Hospital - Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases, 1st Department of Internal Medicine; 🇭🇺 Budapest, Hungary

Haemek medical center; 🇮🇱 Afula, Israel

Flor Ferenc Hospital of Pest County; 🇭🇺 Kistarcsa, Hungary

Wolfson medical center; 🇮🇱 H̱olon, Israel