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

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Pharmacokinetics of Two Doses of INV-202 in Patients With Diabetic Kidney Disease

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Kidney Disease
• Intervention / Treatment: Drug: INV-202; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 265
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Laval, Quebec, Canada, H7T 2P5
      • Centre de Recherche Clinique de Laval
    • Montreal, Quebec, Canada
      • GCP Research
• Georgia
  • Kutaisi, Georgia
    • "Clinic- LJ", LTD
  • Rust'avi, Georgia
    • LTD Clinic Rustavi
  • Tbilisi, Georgia, 0159
    • Archangel St Michael Multiprofile Clinical Hospital Ltd
  • Tbilisi, Georgia, 0159
    • Ltd "Institute of Clinical Cardiology"
  • Tbilisi, Georgia, 0159
    • Tbilisi Heart and Vascular Clinic Ltd
  • Tbilisi, Georgia, 0186
    • LTD Tbilisi Heart Center
  • Tbilisi, Georgia, 0167
    • Georgian Dutch Hospital LLC
  • Tbilisi, Georgia, 0114
    • L. Managadze National Center of Urology, LTD
  • Tbilisi, Georgia, 0159
    • Acad. G. Chapidze Emergency Cardiology Center LTD, Department of Internal Medicine and Medical Research
  • Tbilisi, Georgia, 0159
    • Acad. G. Chapidze Emergency Cardiology Center LTD, Department of Multi-center Clinical Trials
  • 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,
• Hungary
  • Baja, Hungary
    • Diaverum Dialysis Centre of Baja and Nephrology Out-Patient Clinic of Baja St.Rokus Hospital
  • Budapest, Hungary
    • DPC Hospital - Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases, 1st Department of Internal Medicine
  • Debrecen, Hungary
    • University of Debrecen
  • Kistarcsa, Hungary
    • Flor Ferenc Hospital of Pest County
  • Nyíregyháza, Hungary
    • Medifarma-98 Kft
• Israel
  • Afula, Israel
    • HaEmek Medical Center
  • Ashkelon, Israel
    • Barzilai Medical Center
  • Haifa, Israel
    • Rambam Health Care Campus \ Rambam Medical Center
  • H̱olon, Israel
    • Wolfson Medical Center
  • Jerusalem, Israel
    • Hadassah Medical Center
  • Kfar Saba, Israel
    • Meir Medical Center
  • Petah tikva, Israel
    • Rabin Medical Center, Beilinson campus
  • Safed, Israel
    • Ziv Medical Center
  • Safed, Israel
    • Ziv Medical Center - Endocrinology Clinic
• Mexico
  • Cuernavaca, Mexico
    • Instituto de Diabetes Obesidad Y Nutricion , S.C.
  • Guadalajara, Mexico, 44130
    • Centro de Investigación Médica y Reumatología S.C.
  • Guadalajara, Mexico, 45116
    • 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 Clínica y Atención Médica HEPA
  • Mexico City, Mexico, 11850
    • Clinica Integral del Paciente Diabético y Obeso
  • Mérida, Mexico
    • Investigación Médica
  • Mérida, Mexico
    • St Lucas Clinical Research Center SA de CV
  • Veracruz, Mexico, 91851
    • Instituto Veracruzano en Investigación Clínica S.C.
• Serbia
  • Belgrade, Serbia
    • Clinical Hospital Center Zemun
  • Belgrade, Serbia
    • General Hospital "Vršac"
  • Belgrade, Serbia
    • University Clincial Center of Serbia
  • Kragujevac, Serbia
    • University of Kragujevac - Klinicki Centar "Kragujevac"
  • Kruševac, Serbia
    • General Hospital Krusevac
  • Niš, Serbia
    • University Clinical Center Nis, Clinic of Nephrology
  • Novi Sad, Serbia
    • University Clinical Center of Vojvodina
  • Užice, Serbia
    • Healt Center Uzice,General Hospital
  • Zaječar, Serbia
    • Health Center Zajecar
• United States
  • California
    • Garden Grove, California, United States, 92844
      • National Institute of Clinical Research, Inc.
    • Pomona, California, United States, 91768
      • National Institute of Clinical Research, Inc - Pomona
    • Salinas, California, United States, 93901
      • Central Coast Nephrology
    • San Dimas, California, United States, 91773
      • North American Research Institute
    • Upland, California, United States, 91786
      • National Institute of Clinical Research, Inc - Upland
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Research Physicians Network Alliance
    • Cooper City, Florida, United States, 33024
      • ALL Medical Research, LLC
    • Lauderdale Lakes, Florida, United States, 33313
      • South Florida Research Institute
  • Georgia
    • Roswell, Georgia, United States, 30076
      • Endocrine Research Solutions, Inc.
  • Illinois
    • Chicago, Illinois, United States, 60643
      • Research by Design, LLC
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Endocrine and Metabolic Consultants
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Clinical Research Consultants, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Palm Research Center, Inc
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Physicians East, PA
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Northeast Clinical Research Center
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • South Carolina Clinical Research LLC
  • Tennessee
    • Knoxville, Tennessee, United States, 37923
      • Knoxville Kidney Center, PLLC
  • Texas
    • Dallas, Texas, United States, 75231
      • North Texas Endocrine Center
    • Houston, Texas, United States, 77084
      • Biopharma Informatic, LLC
    • Pearland, Texas, United States, 77584
      • LinQ Research, LLC
    • Pearland, Texas, United States, 77854
      • LinQ Research, LLC
    • San Antonio, Texas, United States, 78212
      • Clinical Advancement Center, PLLC
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo Arm	Drug: Placebo; Placebo Matching size and number of tablets; Other Names: None applicable
Experimental: INV 202 10 mg; INV-202 10 mg Arm	Drug: 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.; Other Names: None applicable
Experimental: INV-202 25 mg; INV-202 25 mg Arm	Drug: 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.; Other Names: None applicable

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Inversago Pharma Inc.
• Collaborators: Worldwide Clinical Trials
• Investigators: Study Director: Glenn Crater, MD, Inversago Pharma

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2022
• Primary Completion (Actual): August 20, 2024
• Study Completion (Actual): September 3, 2024

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Diabetic Kidney Disease; Type 2 diabetes mellitus (T2DM); Type 1 diabetes mellitus (T1DM)
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Diabetes Mellitus; Diabetes Complications; Kidney Diseases; Diabetic Nephropathies
• Other Study ID Numbers: INV-CL-106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No