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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05514548
Other study ID # INV-CL-106
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date October 19, 2022
Est. completion date September 24, 2024

Study information

Verified date May 2024
Source Inversago Pharma Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 265
Est. completion date September 24, 2024
Est. primary completion date July 3, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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.
Placebo
Placebo Matching size and number of tablets

Locations

Country Name City State
Canada Centre de recherche Clinique de Laval Laval Quebec
Canada GCP Research Montreal Quebec
Georgia "Clinic- LJ", LTD Kutaisi
Georgia LTD Clinic Rustavi Rust'avi
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 Aleksandre Aladashvili Clinic LLC Tbilisi
Georgia Archangel St Michael Multiprofile Clinical Hospital Ltd Tbilisi
Georgia Georgian Dutch Hospital LLC Tbilisi
Georgia Israel-Georgia Research Clinic Helsicore, LTD Tbilisi
Georgia L. Managadze National Center of Urology, LTD Tbilisi
Georgia LTD "Adapt" Tbilisi
Georgia Ltd "Institute of Clinical Cardiology" Tbilisi
Georgia LTD Tbilisi Heart Center Tbilisi
Georgia National Institute of Endocrinology, LTD, Tbilisi
Georgia Tbilisi Heart and Vascular Clinic LTD Tbilisi
Hungary 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
Israel Haemek medical center Afula
Israel Barzilai Medical Center Ashkelon
Israel Wolfson medical center H_olon
Israel Rambam Health Care Campus \ Rambam Medical Center Haifa
Israel Hadassah Medical Center Jerusalem
Israel Meir Medical Center Kfar Saba
Israel Rabin Medical Center, Beilinson Campus Petah tikva
Israel Ziv Medical Center Safed
Israel Ziv Medical Center - Endocrinology Clinic Safed
Mexico Instituto de Diabetes Obesidad Y Nutricion , S.C. Cuernavaca
Mexico Cento de Investigacion Medica de Occidente, S.C. Guadalajara
Mexico Cento de Investigacion Medica de Occidente, S.C. Guadalajara
Mexico Centro de Investigación Médica y Reumatología S.C. Guadalajara
Mexico Medical Office Guadalajara
Mexico Unidad de Investigación Clinica y atencion Medica HEPA Guadalajara
Mexico Investigación Médica Mérida
Mexico St Lucas Clinical Research Center SA de CV Mérida
Mexico Clinica Integral del Paciente Diabético y Obeso Mexico City
Mexico Instituto Veracruzano en Investigacion Clínica S.C. Veracruz
Serbia 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 Zajecar
United States Northeast Clinical Research Center Bethlehem Pennsylvania
United States Research Physicians Network Alliance Boca Raton Florida
United States University of Vermont Medical Center Burlington Vermont
United States Research by Design, LLC Chicago Illinois
United States ALL Medical Research, LLC Cooper City Florida
United States North Texas Endocrine Center Dallas Texas
United States National Institute of Clinical Research, Inc. Garden Grove California
United States Physicians East, PA Greenville North Carolina
United States Biopharma Informatic, LLC Houston Texas
United States Clinical Research Consultants, LLC Kansas City Missouri
United States Knoxville Kidney Center, Pllc Knoxville Tennessee
United States Palm Research Center, Inc Las Vegas Nevada
United States South Florida Research Institute Lauderdale Lakes Florida
United States South Carolina Clinical Research LLC Orangeburg South Carolina
United States Linq Research, LLC Pearland Texas
United States Linq Research, LLC Pearland Texas
United States National Institute of Clinical Research, Inc - Pomona Pomona California
United States Endocrine and metabolic Consultants Rockville Maryland
United States Endocrine Research Solutions, Inc. Roswell Georgia
United States Central Coast Nephrology Salinas California
United States Clinical Advancement Center, PLLC San Antonio Texas
United States North American Research Institute San Dimas California
United States National Institute of Clinical Research, Inc - Upland Upland California

Sponsors (2)

Lead Sponsor Collaborator
Inversago Pharma Inc. Worldwide Clinical Trials

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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