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

Diabetic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05514548
• Other study ID #: INV-CL-106
• Status: Active, not recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases

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