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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05514548
Recruitment Status : Recruiting
First Posted : August 24, 2022
Last Update Posted : February 12, 2024
Sponsor:
Collaborator:
Worldwide Clinical Trials
Information provided by (Responsible Party):
Inversago Pharma Inc.

Tracking Information
First Submitted Date  ICMJE August 18, 2022
First Posted Date  ICMJE August 24, 2022
Last Update Posted Date February 12, 2024
Actual Study Start Date  ICMJE October 19, 2022
Estimated Primary Completion Date July 3, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2022)
Change in UACR from baseline to W16 [ Time Frame: 16 weeks ]
Measure of UACR at W16 in comparison to baseline to evaluate the effect of INV-202 in participants with diabetic kidney disease (DKD)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2022)
  • Change in urine protein to creatinine ratio (UPCR) from baseline to W16 [ Time Frame: 16 weeks ]
    Measure of UPCR at W16 in comparison to baseline to evaluate the effect of INV-202 in participants with diabetic kidney disease (DKD)
  • Change in eGFR using serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula from baseline to W16 [ Time Frame: 16 weeks ]
    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)
  • Change in eGFR using cystatin C and the CKD-EPI formula from baseline to W16 [ Time Frame: 16 weeks ]
    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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2 Study of INV-202 in Patients With Diabetic Kidney Disease
Official Title  ICMJE 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
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
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Kidney Disease
Intervention  ICMJE
  • 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 Name: None applicable
  • Drug: Placebo
    Placebo Matching size and number of tablets
    Other Name: None applicable
Study Arms  ICMJE
  • Experimental: INV 202 10 mg
    INV-202 10 mg Arm
    Intervention: Drug: INV-202
  • Experimental: INV-202 25 mg
    INV-202 25 mg Arm
    Intervention: Drug: INV-202
  • Placebo Comparator: Placebo
    Placebo Arm
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 22, 2022)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 24, 2024
Estimated Primary Completion Date July 3, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Glenn Crater, MD 1-919-371-8411 clinicalstrials-inquiries@inversago.com
Contact: Karine Lalonde, MSc 438-300-2550 clinicalstrials-inquiries@inversago.com
Listed Location Countries  ICMJE Canada,   Georgia,   Hungary,   Israel,   Mexico,   Serbia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05514548
Other Study ID Numbers  ICMJE INV-CL-106
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Inversago Pharma Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Inversago Pharma Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Worldwide Clinical Trials
Investigators  ICMJE
Study Director: Glenn Crater, MD Inversago Pharma
PRS Account Inversago Pharma Inc.
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP