Diabetic Kidney Disease
Conditions
Keywords
Diabetic Kidney Disease, Type 1 diabetes mellitus (T1DM), Type 2 diabetes mellitus (T2DM)
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.
Interventions
DRUGINV-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.
DRUGPlacebo
Placebo Matching size and number of tablets
Sponsors
Worldwide Clinical Trials
Inversago Pharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in UACR from baseline to W16 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in urine protein to creatinine ratio (UPCR) from baseline to W16 | 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 | 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 | 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) |
Countries
Canada, Georgia, Hungary, Israel, Mexico, Serbia, United States
Outcome results
None listed