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Diabetic Kidney DiseasePhase 2NCT05514548

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

A Phase 2 study testing INV-202 in people with Diabetic Kidney Disease, run by Inversago Pharma Inc. at 72 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Kidney Disease
What is being tested?
INV-202
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
265 participants
Where
72 sitesin 7 countries
Study dates
19 Oct 2022to 3 Sep 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
  • Other causes of kidney disease that are not DKD (eg, lupus nephritis). Of note, hypertension is not an exclusion criteria.
  • Participants with an eGFR <30 ml/min/1.73m².
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  • 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.
  • Subjects with a history of other severe psychiatric disorders (eg, schizophrenia, bipolar disorder).
  • Score of the 9-question Patient Health Questionnaire (PHQ-9) ≥15 at baseline.
  • 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.
  • QTc >500 msec at baseline.
  • Any chronic medications started or changed within the past 3 months or at risk of needing to be changed during the study.
  • Participants with a history of hyperthyroidism or other thyroid diseases.
  • 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.
  • Having taken any investigational compound within 30 days, or 5 half-lives of the drug, whichever is longer, before the Screening Visit.

Trial locations and contacts

72 sites in 7 countries.

72 sites in 7 countries

United States23 sites

  • Northeast Clinical Research Center

    Bethlehem, Pennsylvania, 18017

  • Research Physicians Network Alliance

    Boca Raton, Florida, 33431

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Research by Design, LLC

    Chicago, Illinois, 60643

  • ALL Medical Research, LLC

    Cooper City, Florida, 33024

  • North Texas Endocrine Center

    Dallas, Texas, 75231

  • National Institute of Clinical Research, Inc.

    Garden Grove, California, 92844

  • Physicians East, PA

    Greenville, North Carolina, 27834

  • Biopharma Informatic, LLC

    Houston, Texas, 77084

  • Clinical Research Consultants, LLC

    Kansas City, Missouri, 64111

  • Knoxville Kidney Center, Pllc

    Knoxville, Tennessee, 37923

  • Palm Research Center, Inc

    Las Vegas, Nevada, 89148

  • South Florida Research Institute

    Lauderdale Lakes, Florida, 33313

  • South Carolina Clinical Research LLC

    Orangeburg, South Carolina, 29118

  • Linq Research, LLC

    Pearland, Texas, 77584

  • Linq Research, LLC

    Pearland, Texas, 77854

  • National Institute of Clinical Research, Inc - Pomona

    Pomona, California, 91768

  • Endocrine and metabolic Consultants

    Rockville, Maryland, 20852

  • Endocrine Research Solutions, Inc.

    Roswell, Georgia, 30076

  • Central Coast Nephrology

    Salinas, California, 93901

  • Clinical Advancement Center, PLLC

    San Antonio, Texas, 78212

  • North American Research Institute

    San Dimas, California, 91773

  • National Institute of Clinical Research, Inc - Upland

    Upland, California, 91786

Other trials in United States

Georgia14 sites

  • "Clinic- LJ", LTD

    Kutaisi

  • LTD Clinic Rustavi

    Rustavi

  • L. Managadze National Center of Urology, LTD

    Tbilisi, 0114

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

    Tbilisi, 0159

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

    Tbilisi, 0159

  • Archangel St Michael Multiprofile Clinical Hospital Ltd

    Tbilisi, 0159

  • Ltd "Institute of Clinical Cardiology"

    Tbilisi, 0159

  • Tbilisi Heart and Vascular Clinic LTD

    Tbilisi, 0159

  • Georgian Dutch Hospital LLC

    Tbilisi, 0167

  • LTD Tbilisi Heart Center

    Tbilisi, 0186

  • Aleksandre Aladashvili Clinic LLC

    Tbilisi

  • Israel-Georgia Research Clinic Helsicore, LTD

    Tbilisi

  • LTD "Adapt"

    Tbilisi

  • National Institute of Endocrinology, LTD,

    Tbilisi

Other trials in Georgia

Mexico10 sites

  • Instituto de Diabetes Obesidad Y Nutricion , S.C.

    Cuernavaca

  • Centro de Investigación Médica y Reumatología S.C.

    Guadalajara, 44130

  • Cento de Investigacion Medica de Occidente, S.C.

    Guadalajara, 45116

  • Cento de Investigacion Medica de Occidente, S.C.

    Guadalajara

  • Medical Office

    Guadalajara

  • Unidad de Investigación Clinica y atencion Medica HEPA

    Guadalajara

  • Investigación Médica

    Mérida

  • St Lucas Clinical Research Center SA de CV

    Mérida

  • Clinica Integral del Paciente Diabético y Obeso

    Mexico City, 11850

  • Instituto Veracruzano en Investigacion Clínica S.C.

    Veracruz, 91851

Other trials in Mexico

Israel9 sites

  • Haemek medical center

    Afula

  • Barzilai Medical Center

    Ashkelon

  • Rambam Health Care Campus \ Rambam Medical Center

    Haifa

  • Wolfson medical center

    Holon

  • Hadassah Medical Center

    Jerusalem

  • Meir Medical Center

    Kfar Saba

  • Rabin Medical Center, Beilinson Campus

    Petah Tikva

  • Ziv Medical Center - Endocrinology Clinic

    Safed

  • Ziv Medical Center

    Safed

Other trials in Israel

Serbia9 sites

  • Clinical Hospital Center Zemun

    Belgrade

  • General Hospital "Vršac"

    Belgrade

  • University Clincial Center of Serbia

    Belgrade

  • University of Kragujevac - Klinicki Centar "Kragujevac"

    Kragujevac

  • General Hospital Krusevac

    Kruševac

  • University Clinical Center Nis, Clinic of Nephrology

    Niš

  • University Clinical Center of Vojvodina

    Novi Sad

  • Healt Center Uzice,General Hospital

    Užice

  • Health Center Zajecar

    Zaječar

Other trials in Serbia

Hungary5 sites

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

    Baja

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

    Budapest

  • University of Debrecen

    Debrecen

  • Flor Ferenc Hospital of Pest County

    Kistarcsa

  • Medifarma-98 Kft

    Nyíregyháza

Other trials in Hungary

Canada2 sites

  • Centre de recherche Clinique de Laval

    Laval, Quebec, H7T 2P5

  • GCP Research

    Montreal, Quebec

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
INV-202, Placebo
Keywords
Diabetic Kidney Disease, Type 1 diabetes mellitus (T1DM), Type 2 diabetes mellitus (T2DM)
Medical subject headings
Diabetic Nephropathies, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INV-202Drug

    Also called None applicable

    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.

  • PlaceboDrug

    Also called None applicable

    Placebo Matching size and number of tablets

Study groups in NCT05514548
Study groupRoleWhat they receive
INV 202 10 mgExperimentalINV-202 10 mg Arm
Receives: Drug: INV-202
INV-202 25 mgExperimentalINV-202 25 mg Arm
Receives: Drug: INV-202
PlaceboPlacebo comparatorPlacebo Arm
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 16 weeks

Secondary outcomes (3)

  1. 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)

    Measured: 16 weeks

  2. 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)

    Measured: 16 weeks

  3. 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)

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2022
  2. Study start19 Oct 2022
  3. Primary completion20 Aug 2024
  4. Study completion3 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
265 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05514548
Sponsor's protocol ID
INV-CL-106
Status last verified
Aug 2025
First submitted
18 Aug 2022
Last updated
11 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cherney DZI, Bonefeld K, Crater G, Dwyer JP, Frenkel O, Furberg JF, Knop FK, Kunos G, Lalonde K, Wheeler DC, Wanner C; trial investigators. A double-blind, randomized, placebo-controlled, phase 2 trial examined the efficacy and safety of monlunabant in adults with diabetic kidney disease. Kidney Int. 2026 Jun;109(6):1296-1307. doi: 10.1016/j.kint.2026.02.023. Epub 2026 Mar 20.

    PubMed 41866124

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing INV-202 in people with Diabetic Kidney Disease, run by Inversago Pharma Inc. at 72 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Georgia, Mexico, Israel, Serbia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in UACR from baseline to W16 (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05514548, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.

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