INV 202 for Diabetic Kidney Disease

No longer recruiting at 75 trial locations

Overseen By Sara Bartolanzo

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Inversago Pharma Inc.

Must be taking: ACEi, ARB

Must not be taking: Cannabis, Cytochrome P450 drugs

Disqualifiers: Uncontrolled hypertension, Hepatic impairment, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new drug called INV-202 to determine its effectiveness in treating diabetic kidney disease, a condition where diabetes damages the kidneys. The study aims to assess the effectiveness and safety of INV-202 at various doses compared to a placebo (a non-active substance). Individuals with diabetic kidney disease from either Type 1 or Type 2 diabetes for over a year, who are on stable diabetes medication and experience albuminuria (protein leakage into urine), might be suitable for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that you stay on a stable dose of your current anti-diabetic medications and ACEi or ARB for at least 4 months before and during the study. However, you cannot take certain medications that affect liver enzymes (cytochrome P450) during the study.

Is there any evidence suggesting that INV-202 is likely to be safe for humans?

Research has shown that INV-202 was well-tolerated in earlier studies. In one study, participants took INV-202 for 28 days without serious side effects. No severe medical issues occurred, and no participants stopped treatment due to problems. Additionally, there were no major changes in liver health.

These early results suggest that INV-202 is safe. However, this information is based on a short period. Ongoing studies will provide more information about the long-term safety of INV-202 for treating diabetic kidney disease. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Diabetic Kidney Disease?

Unlike most treatments for diabetic kidney disease, which often focus on controlling blood sugar or blood pressure, INV-202 offers a novel approach by potentially addressing kidney health directly. Researchers are excited about INV-202 because it has a unique mechanism of action that targets kidney-specific pathways, which could lead to more effective protection and preservation of kidney function. With two experimental doses, 10 mg and 25 mg, INV-202 might provide flexible and tailored options for patients, potentially reducing progression of kidney damage more effectively than existing therapies.

What evidence suggests that INV-202 might be an effective treatment for Diabetic Kidney Disease?

Research suggests that INV-202 might help treat diabetic kidney disease. Animal studies have shown that INV-202 can reduce kidney damage caused by diabetes by protecting important kidney cells and reducing scarring. In this trial, participants will receive either INV-202 at different dosages or a placebo. However, in human trials, a similar drug, also called INV-202, did not achieve its main goals. This uncertainty means its effectiveness in people remains unclear. While animal results offer hope, further research is necessary to determine its true benefit for humans. ^{1 2 3 4 6}

Who Is on the Research Team?

Glenn Crater, MD

Principal Investigator

Inversago Pharma

Are You a Good Fit for This Trial?

This trial is for adults with Diabetic Kidney Disease linked to Type 1 or Type 2 diabetes, who have managed their diabetes stably for at least 4 months and have an HbA1c below 9.5%. It's not for those with recent drug abuse, thyroid issues, significant psychiatric disorders, other kidney diseases (except hypertension), or those using cannabis products recently.

Inclusion Criteria

I have been diagnosed with Diabetic Kidney Disease.

Is your hemoglobin A1C (HbA1c) less than 9.5%?

I have been on a stable diabetes medication regimen for at least 4 months.

Exclusion Criteria

You have a history of severe mental health disorders such as depression, bipolar disorder or schizophrenia, or have had thoughts of suicide or attempted suicide in the past two years. If your score is 15 or higher on the PHQ-9 questionnaire, you will also be excluded.

I have had epilepsy or brain surgery in the past.

You have taken any experimental medication within the past month or within 5 half-lives of the drug, whichever is longer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment

Participants receive the study medication (INV-202 10 mg, INV-202 25 mg, or placebo) once daily for 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a Safety Follow-Up Visit via phone call 2 weeks after the End of Treatment Visit

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• INV-202
• Placebo

Trial Overview The study tests INV-202 against a placebo in treating Diabetic Kidney Disease. Participants will be randomly assigned to receive either the investigational drug INV-202 or a placebo to evaluate its effectiveness and safety.

How Is the Trial Designed?

Group I: INV-202 25 mg Experimental Treatment 1 Intervention

INV-202 25 mg Arm

Group II: INV 202 10 mg Experimental Treatment 1 Intervention

INV-202 10 mg Arm

Group III: Placebo Placebo Group 1 Intervention

Placebo Arm

Who Is Running the Clinical Trial?

Inversago Pharma Inc.

Lead Sponsor

Trials

4

Recruited

590+

Worldwide Clinical Trials

Collaborator

Trials

70

Recruited

15,800+

Published Research Related to This Trial

Sotagliflozin, a new medication for diabetes, was found to be safe for renal function, showing no significant adverse effects on kidney health in a review of 14 studies involving 17,574 participants, including those with existing renal impairment.

The drug did not significantly change urinary albumin excretion or the risk of composite renal events, indicating that while it is safe, more research is needed to fully understand its effectiveness in preventing diabetic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the dual sodium-glucose co-transporter-1 and -2 inhibitor sotagliflozin on renal outcomes in type 1 diabetes and type 2 diabetes: A systematic review and meta-analysis of randomized controlled trials. Bantounou, MA., Sardellis, P., Thuemmler, R., et al.[2023]

Dapagliflozin, used to treat type 2 diabetes, showed only small and temporary reductions in kidney function (eGFR) at week 1, which returned to baseline by week 24 and remained stable up to 102 weeks, indicating its renal safety.

The frequency of renal adverse events with dapagliflozin was similar to that of placebo, with very few serious events reported, suggesting that dapagliflozin does not increase the risk of acute renal toxicity in patients with normal or mildly impaired kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of dapagliflozin on renal function in patients with type 2 diabetes. Kohan, DE., Fioretto, P., Johnsson, K., et al.[2021]

Citations

1. inversago.com inversago.com/en/2022/inversago-pharma-presents-data-on-inv-202-in-diabetic-nephropathy-at-the-era-2022-congress/

Inversago Pharma presents data on INV-202 in Diabetic ... These data show that INV-202, the company's lead peripheral CB1 blocker, reduced renal injury in a murine model of Streptozotocin (STZ)-induced Diabetes.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10479578/

Therapeutic potential of a novel peripherally restricted CB1R ... INV-202 reduced glomerular injury, preserved podocyte structure and function, reduced injury to PTECs, and ultimately reduced renal fibrosis in a streptozotocin ...

3. hcplive.com hcplive.com/view/monlunabant-misses-primary-endpoint-in-phase-2-diabetic-kidney-disease-trial

Monlunabant Misses Primary Endpoint in Phase 2 Diabetic ... Novo Nordisk has completed a phase 2 trial of monlunabant, formerly INV-202, in patients with diabetic kidney disease, according to a 2024 financial report ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05514548

Phase 2 Study of INV-202 in Patients With Diabetic Kidney ... The study is designed to assess the efficacy, safety, tolerability, and transformation within the human body of INV-202 investigational drug

5. withpower.com withpower.com/trial/phase-2-diabetic-nephropathies-9-2022-f2799

INV-202 for Diabetic Kidney Disease · Info for Participants Sotagliflozin, a new medication for diabetes, was found to be safe for renal function, showing no significant adverse effects on kidney health in a review of 14 ...

6. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.15353

Effects of CB1R inverse agonist, INV‐202, in patients with ... 3.2 Safety. INV-202 was well tolerated over 28 days of treatment, with no serious or severe TEAEs, discontinuations or changes in liver or ...