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

NCT ID: NCT05514548

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 265 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-19
• Study Completion Date: 2024-09-03

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.

Conditions

Diabetic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

INV 202 10 mg

INV-202 10 mg Arm

Group Type: EXPERIMENTAL

INV-202

Intervention Type: DRUG

INV-202 is a new generation of CB1R antagonist developed by Inversago for potential use as a therapeutic method for the treatment of metabolic disorders, including nonalcoholic steatohepatitis, diabetes and its complications (such as DKD), and hypertriglyceridemia.

INV-202 25 mg

INV-202 25 mg Arm

Group Type: EXPERIMENTAL

INV-202

Intervention Type: DRUG

INV-202 is a new generation of CB1R antagonist developed by Inversago for potential use as a therapeutic method for the treatment of metabolic disorders, including nonalcoholic steatohepatitis, diabetes and its complications (such as DKD), and hypertriglyceridemia.

Placebo

Placebo Arm

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo Matching size and number of tablets

Interventions

INV-202

INV-202 is a new generation of CB1R antagonist developed by Inversago for potential use as a therapeutic method for the treatment of metabolic disorders, including nonalcoholic steatohepatitis, diabetes and its complications (such as DKD), and hypertriglyceridemia.

Intervention Type: DRUG

Placebo

Placebo Matching size and number of tablets

Intervention Type: DRUG

Other Intervention Names

None applicable; None applicable

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Worldwide Clinical Trials

OTHER

Sponsor Role: collaborator

Inversago Pharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Glenn Crater, MD

Role: STUDY_DIRECTOR

Inversago Pharma

Locations

National Institute of Clinical Research, Inc.

Garden Grove, California, United States

National Institute of Clinical Research, Inc - Pomona

Pomona, California, United States

Central Coast Nephrology

Salinas, California, United States

North American Research Institute

San Dimas, California, United States

National Institute of Clinical Research, Inc - Upland

Upland, California, United States

Research Physicians Network Alliance

Boca Raton, Florida, United States

ALL Medical Research, LLC

Cooper City, Florida, United States

South Florida Research Institute

Lauderdale Lakes, Florida, United States

Endocrine Research Solutions, Inc.

Roswell, Georgia, United States

Research by Design, LLC

Chicago, Illinois, United States

Endocrine and metabolic Consultants

Rockville, Maryland, United States

Clinical Research Consultants, LLC

Kansas City, Missouri, United States

Palm Research Center, Inc

Las Vegas, Nevada, United States

Physicians East, PA

Greenville, North Carolina, United States

Northeast Clinical Research Center

Bethlehem, Pennsylvania, United States

South Carolina Clinical Research LLC

Orangeburg, South Carolina, United States

Knoxville Kidney Center, Pllc

Knoxville, Tennessee, United States

North Texas Endocrine Center

Dallas, Texas, United States

Biopharma Informatic, LLC

Houston, Texas, United States

Linq Research, LLC

Pearland, Texas, United States

Linq Research, LLC

Pearland, Texas, United States

Clinical Advancement Center, PLLC

San Antonio, Texas, United States

University of Vermont Medical Center

Burlington, Vermont, United States

Centre de recherche Clinique de Laval

Laval, Quebec, Canada

GCP Research

Montreal, Quebec, Canada

"Clinic- LJ", LTD

Kutaisi, , Georgia

LTD Clinic Rustavi

Rustavi, , Georgia

L. Managadze National Center of Urology, LTD

Tbilisi, , Georgia

Acad. G. Chapidze Emergency Cardiology Center LTD, Department of Internal Medicine and Medical Research

Tbilisi, , Georgia

Acad. G. Chapidze Emergency Cardiology Center LTD, Department of Multi-center Clinical Trials

Tbilisi, , Georgia

Archangel St Michael Multiprofile Clinical Hospital Ltd

Tbilisi, , Georgia

Ltd "Institute of Clinical Cardiology"

Tbilisi, , Georgia

Tbilisi Heart and Vascular Clinic LTD

Tbilisi, , Georgia

Georgian Dutch Hospital LLC

Tbilisi, , Georgia

LTD Tbilisi Heart Center

Tbilisi, , Georgia

Aleksandre Aladashvili Clinic LLC

Tbilisi, , Georgia

Israel-Georgia Research Clinic Helsicore, LTD

Tbilisi, , Georgia

LTD "Adapt"

Tbilisi, , Georgia

National Institute of Endocrinology, LTD,

Tbilisi, , Georgia

Diaverum Dialysis Centre of Baja and Nephrology Out-Patient Clinic of Baja St.Rokus Hospital

Baja, , Hungary

DPC Hospital - Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases, 1st Department of Internal Medicine

Budapest, , Hungary

University of Debrecen

Debrecen, , Hungary

Flor Ferenc Hospital of Pest County

Kistarcsa, , Hungary

Medifarma-98 Kft

Nyíregyháza, , Hungary

Haemek medical center

Afula, , Israel

Barzilai Medical Center

Ashkelon, , Israel

Rambam Health Care Campus \ Rambam Medical Center

Haifa, , Israel

Wolfson medical center

Holon, , Israel

Hadassah Medical Center

Jerusalem, , Israel

Meir Medical Center

Kfar Saba, , Israel

Rabin Medical Center, Beilinson Campus

Petah Tikva, , Israel

Ziv Medical Center - Endocrinology Clinic

Safed, , Israel

Ziv Medical Center

Safed, , Israel

Instituto de Diabetes Obesidad Y Nutricion , S.C.

Cuernavaca, , Mexico

Centro de Investigación Médica y Reumatología S.C.

Guadalajara, , Mexico

Cento de Investigacion Medica de Occidente, S.C.

Guadalajara, , Mexico

Cento de Investigacion Medica de Occidente, S.C.

Guadalajara, , Mexico

Medical Office

Guadalajara, , 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

St Lucas Clinical Research Center SA de CV

Mérida, , Mexico

Instituto Veracruzano en Investigacion Clínica S.C.

Veracruz, , Mexico

Clinical Hospital Center Zemun

Belgrade, , Serbia

General Hospital "Vršac"

Belgrade, , Serbia

University Clincial Center of Serbia

Belgrade, , Serbia

University of Kragujevac - Klinicki Centar "Kragujevac"

Kragujevac, , Serbia

General Hospital Krusevac

Kruševac, , Serbia

University Clinical Center Nis, Clinic of Nephrology

Niš, , Serbia

University Clinical Center of Vojvodina

Novi Sad, , Serbia

Healt Center Uzice,General Hospital

Užice, , Serbia

Health Center Zajecar

Zaječar, , Serbia

Countries

United States; Canada; Georgia; Hungary; Israel; Mexico; Serbia

Other Identifiers

INV-CL-106

Identifier Type: -

Identifier Source: org_study_id