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

NCT05514548 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: INV-CL-106
• Study Type: interventional
• Target: 265
• Locations: 7 countries
• Sites: 72

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.

Conditions

Diabetic Kidney Disease

Keywords

Diabetic Kidney Disease; Type 1 diabetes mellitus (T1DM); Type 2 diabetes mellitus (T2DM)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in urine protein to creatinine ratio (UPCR) from baseline to W16

  16 weeks

• Change in eGFR using serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula from baseline to W16

  16 weeks

• Change in eGFR using cystatin C and the CKD-EPI formula from baseline to W16

  16 weeks

Study Arms (3)

INV 202 10 mg

EXPERIMENTAL

INV-202 10 mg Arm

Drug: INV-202

INV-202 25 mg

EXPERIMENTAL

INV-202 25 mg Arm

Drug: INV-202

Placebo

PLACEBO COMPARATOR

Placebo Arm

Drug: Placebo

Interventions

INV-202 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.

Also known as: None applicable

INV 202 10 mg; INV-202 25 mg

Placebo DRUG

Placebo Matching size and number of tablets

Also known as: None applicable

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants ≥18 years of age.
• Able and willing to give informed consent and to comply with scheduled visits and trial procedures.
• A diagnosis of DKD due to either T1DM or T2DM (diagnosed for ≥1 year)
• On a stable anti-diabetic medication regimen for ≥4 months prior to randomization with a hemoglobin A1C (HbA1c) \<9.5%.
• Participants with T1DM may not be on any glucose lowering medications beyond insulin.
• Participants with T2DM may be on more than 1 anti diabetic medication regimen (eg, SGLT2 inhibitor, insulin, or other anti-diabetic medication regimen).
• HbA1c should have been performed within the last 4 months prior to randomization.
• 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.
• Participants taking finerenone (not required), on a stable dose for ≥4 months prior to randomization.
• Presence of albuminuria with a UACR \>100 mg/g and \<3000 mg/g at screening.

You may not qualify if:

• 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.
• Participants not fully vaccinated for Coronavirus Disease 2019 (COVID 19).
• 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.
• Participants who have fully recovered from COVID 19 and have a negative COVID-19 test ≥14 days before screening are eligible.
• Participants with an eGFR \<30 ml/min/1.73m².
• Participants who have had acute kidney injury (AKI) within the past 3 months, or have ever received dialysis.
• Participants with a history of epilepsy or intracranial surgery.
• Uncontrolled hypertension with measurements of systolic pressures \>160 or diastolic measurements \>100 at the Screening Visit.
• Active substance abuse including inhaled or injection drugs in the year prior to screening.
• Use of cannabis or cannabinoid containing compounds within 90 days prior to screening.
• Pregnancy, planned pregnancy, potential for pregnancy or unwillingness to use effective birth control during the trial, as well as breast feeding.
• Evidence of moderate to severe hepatic impairment as defined by Child's-Pugh B or C.
• Subjects with a history of significant psychiatric disorder, including but not limited to:
• Major depression within the last 2 years.
• Any history of a suicide attempt or suicidal ideation.

Sponsors & Collaborators

• Inversago Pharma Inc.: lead
• Worldwide Clinical Trials: collaborator

Study Sites (72)

National Institute of Clinical Research, Inc.

Garden Grove, California, 92844, United States

Location

National Institute of Clinical Research, Inc - Pomona

Pomona, California, 91768, United States

Location

Central Coast Nephrology

Salinas, California, 93901, United States

Location

North American Research Institute

San Dimas, California, 91773, United States

Location

National Institute of Clinical Research, Inc - Upland

Upland, California, 91786, United States

Location

Research Physicians Network Alliance

Boca Raton, Florida, 33431, United States

Location

ALL Medical Research, LLC

Cooper City, Florida, 33024, United States

Location

South Florida Research Institute

Lauderdale Lakes, Florida, 33313, United States

Location

Endocrine Research Solutions, Inc.

Roswell, Georgia, 30076, United States

Location

Research by Design, LLC

Chicago, Illinois, 60643, United States

Location

Endocrine and metabolic Consultants

Rockville, Maryland, 20852, United States

Location

Clinical Research Consultants, LLC

Kansas City, Missouri, 64111, United States

Location

Palm Research Center, Inc

Las Vegas, Nevada, 89148, United States

Location

Physicians East, PA

Greenville, North Carolina, 27834, United States

Location

Northeast Clinical Research Center

Bethlehem, Pennsylvania, 18017, United States

Location

South Carolina Clinical Research LLC

Orangeburg, South Carolina, 29118, United States

Location

Knoxville Kidney Center, Pllc

Knoxville, Tennessee, 37923, United States

Location

North Texas Endocrine Center

Dallas, Texas, 75231, United States

Location

Biopharma Informatic, LLC

Houston, Texas, 77084, United States

Location

Linq Research, LLC

Pearland, Texas, 77584, United States

Location

Linq Research, LLC

Pearland, Texas, 77854, United States

Location

Clinical Advancement Center, PLLC

San Antonio, Texas, 78212, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Centre de recherche Clinique de Laval

Laval, Quebec, H7T 2P5, Canada

Location

GCP Research

Montreal, Quebec, Canada

Location

"Clinic- LJ", LTD

Kutaisi, Georgia

Location

LTD Clinic Rustavi

Rustavi, Georgia

Location

L. Managadze National Center of Urology, LTD

Tbilisi, 0114, Georgia

Location

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

Tbilisi, 0159, Georgia

Location

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

Tbilisi, 0159, Georgia

Location

Archangel St Michael Multiprofile Clinical Hospital Ltd

Tbilisi, 0159, Georgia

Location

Ltd "Institute of Clinical Cardiology"

Tbilisi, 0159, Georgia

Location

Tbilisi Heart and Vascular Clinic LTD

Tbilisi, 0159, Georgia

Location

Georgian Dutch Hospital LLC

Tbilisi, 0167, Georgia

Location

LTD Tbilisi Heart Center

Tbilisi, 0186, Georgia

Location

Aleksandre Aladashvili Clinic LLC

Tbilisi, Georgia

Location

Israel-Georgia Research Clinic Helsicore, LTD

Tbilisi, Georgia

Location

LTD "Adapt"

Tbilisi, Georgia

Location

National Institute of Endocrinology, LTD,

Tbilisi, Georgia

Location

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

Baja, Hungary

Location

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

Budapest, Hungary

Location

University of Debrecen

Debrecen, Hungary

Location

Flor Ferenc Hospital of Pest County

Kistarcsa, Hungary

Location

Medifarma-98 Kft

Nyíregyháza, Hungary

Location

Haemek medical center

Afula, Israel

Location

Barzilai Medical Center

Ashkelon, Israel

Location

Rambam Health Care Campus \ Rambam Medical Center

Haifa, Israel

Location

Wolfson medical center

Holon, Israel

Location

Hadassah Medical Center

Jerusalem, Israel

Location

Meir Medical Center

Kfar Saba, Israel

Location

Rabin Medical Center, Beilinson Campus

Petah Tikva, Israel

Location

Ziv Medical Center - Endocrinology Clinic

Safed, Israel

Location

Ziv Medical Center

Safed, Israel

Location

Instituto de Diabetes Obesidad Y Nutricion , S.C.

Cuernavaca, Mexico

Location

Centro de Investigación Médica y Reumatología S.C.

Guadalajara, 44130, Mexico

Location

Cento de Investigacion Medica de Occidente, S.C.

Guadalajara, 45116, Mexico

Location

Cento de Investigacion Medica de Occidente, S.C.

Guadalajara, Mexico

Location

Medical Office

Guadalajara, Mexico

Location

Unidad de Investigación Clinica y atencion Medica HEPA

Guadalajara, Mexico

Location

Clinica Integral del Paciente Diabético y Obeso

Mexico City, 11850, Mexico

Location

Investigación Médica

Mérida, Mexico

Location

St Lucas Clinical Research Center SA de CV

Mérida, Mexico

Location

Instituto Veracruzano en Investigacion Clínica S.C.

Veracruz, 91851, Mexico

Location

Clinical Hospital Center Zemun

Belgrade, Serbia

Location

General Hospital "Vršac"

Belgrade, Serbia

Location

University Clincial Center of Serbia

Belgrade, Serbia

Location

University of Kragujevac - Klinicki Centar "Kragujevac"

Kragujevac, Serbia

Location

General Hospital Krusevac

Kruševac, Serbia

Location

University Clinical Center Nis, Clinic of Nephrology

Niš, Serbia

Location

University Clinical Center of Vojvodina

Novi Sad, Serbia

Location

Healt Center Uzice,General Hospital

Užice, Serbia

Location

Health Center Zajecar

Zaječar, Serbia

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Glenn Crater, MD

  Inversago Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 24, 2022
• Study Start: October 19, 2022
• Primary Completion: August 20, 2024
• Study Completion: September 3, 2024
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

HU (5); ME (10); SE (9); CA (2); US (23); GE (14); IL (9)