2-HPβCD for Diabetic Kidney Disease

Overseen By Pablo Guzman, M.D

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: ZyVersa Therapeutics, Inc.

Must be taking: ACEi, ARB, SGLT2, GLP-1

Must not be taking: Steroids, Cyclodextrin, Antibodies, NSAIDs

Disqualifiers: Solitary kidney, Uncontrolled diabetes, Uncontrolled hypertension, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called 2-HPβCD to determine its effectiveness for people with type 2 diabetes and diabetic kidney disease (DKD). The main goal is to see if this treatment can improve kidney function and reduce protein in urine, a common issue for those with DKD. It specifically involves individuals diagnosed with type 2 diabetes and DKD, who experience proteinuria (excessive protein in urine) and have maintained stable doses of their diabetes and blood pressure medications for at least three months. Participants will receive the treatment through an IV infusion over a 12-week period. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

You will need to keep your diabetes and blood pressure medications stable for at least 3 months before joining the study. Some medications, like NSAIDs, are not allowed during the study, except for low-dose aspirin if it's been stable for 3 months.

Is there any evidence suggesting that 2-HPβCD is likely to be safe for humans?

Research has shown that 2-hydroxypropyl-β-cyclodextrin (2-HPβCD) has been studied for safety in treating kidney problems. In studies with diabetic mice, 2-HPβCD significantly lowered cholesterol in the kidneys without causing harm, suggesting potential safety for humans.

Since the trial is in Phase 2, researchers have already tested the treatment in a small group of people for safety. So far, no major safety issues have emerged. This phase aims to further assess its safety and effectiveness in more patients. While early study results are promising, more research is needed to confirm its safety for people with diabetic kidney disease. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for diabetic kidney disease, which often include blood pressure medications like ACE inhibitors or ARBs, 2-HPβCD is unique because it is administered through an IV infusion and introduces a novel mechanism of action. While most current treatments focus on managing symptoms and slowing disease progression, 2-HPβCD works by potentially removing cholesterol from the kidneys, which could address the root cause of the condition. Researchers are excited about 2-HPβCD because it offers a new way to tackle the disease, potentially improving kidney function more directly and effectively than existing options.

What evidence suggests that 2-HPβCD might be an effective treatment for diabetic kidney disease?

Research has shown that a substance called 2-hydroxypropyl-β-cyclodextrin (2-HPβCD), which participants in this trial will receive, might help treat diabetic kidney disease. Previous studies found that 2-HPβCD can reduce excess protein in urine and slow kidney damage in experimental models of kidney disease. It improves kidney function, which is crucial for people with diabetic kidney disease. These findings suggest that 2-HPβCD could effectively manage symptoms and possibly slow the progression of kidney damage in those with this condition. ^{1 6 7 8 9}

Who Is on the Research Team?

Pablo Pergola, M.D PHD

Principal Investigator

Clinical Advancement Center, PLLC

Are You a Good Fit for This Trial?

Adults with type 2 diabetes and diabetic kidney disease (DKD) who have protein in their urine can join this study. They must be able to consent, have a BMI of ≤40 kg/m^2, stable doses of certain blood pressure meds for 3 months, and agree to use contraception if needed. Those with eGFR between 30-90 mL/min/1.73 m^2 are eligible.

Inclusion Criteria

My BMI is 40 or less.

My kidney test shows protein levels between 400 and 3500 mg/g.

My average urine protein to creatinine ratio is between 400 and 3500 mg/g.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive 2-hydroxypropyl-β-cyclodextrin (2-HPβCD) intravenously to evaluate clinical efficacy and safety

12 weeks

Visits on Day 1, Day 29, Day 57, and Day 85

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 2-HPβCD

Trial Overview The trial is testing the safety and effectiveness of a single dose of an intravenous drug called 2-hydroxypropyl-β-cyclodextrin (2-HPβCD) on patients with DKD. It's an open-label study conducted across two or three centers.

How Is the Trial Designed?

Group I: 2HPβCD Experimental Treatment 1 Intervention

Study drug will be administered by IV infusion during the treatment period.

Who Is Running the Clinical Trial?

ZyVersa Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

8+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06489340

NCT06489340 | P2a Open Label Study to Evaluate 2- ... This is an open label, two to three center study to evaluate the clinical efficacy and safety of 1 dose level of 2-hydroxypropyl-β-cyclodextrin (2-HPβCD) given ...

2. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06489340/

Trial | NCT06489340 This is a Phase 2a, open label, two to three center study to evaluate the clinical efficacy and safety of 1 dose level of 2-hydroxypropyl-β-cyclodextrin (2- ...

3. withpower.com withpower.com/trial/phase-2-kidney-diseases-6-2024-32a4a

2-HPβCD for Diabetic Kidney Disease This is an open label, two to three center study to evaluate the clinical efficacy and safety of 1 dose level of 2-hydroxypropyl-β-cyclodextrin given ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6278936/

Hydroxypropyl-β-cyclodextrin protects from kidney disease ... HPβCD prevents proteinuria and renal function decline and prolongs survival in experimental AS nephropathy. We then investigated the potential ...

5. investors.zyversa.com investors.zyversa.com/node/8161/pdf

ZyVersa Therapeutics Engages CRO, George Clinical, for ... VAR 200 has potential to treat multiple kidney diseases, including diabetic kidney disease, and rare kidney diseases, FSGS (focal segmental.

6. carbohyde.com carbohyde.com/p2a-open-label-study-to-evaluate-2-hp%CE%B2cd-in-subjects-with-diabetic-kidney-disease/

P2a Open Label Study to Evaluate 2-HPβCD in Subjects ... According to the proposed mechanism of action, HPBCD entraps and passively removes intracellular cholesterol from the kidney. It is also ...

7. cyclodextrinnews.com cyclodextrinnews.com/2020/11/12/cholesterol-chelator-hp%CE%B2cd-for-renal-diseases/

Cholesterol chelator, HPβCD for renal diseases 2-HPβCD significantly reduced total cholesterol in the kidney cortex compared with untreated diabetic mice. This was associated with a ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06489340/p2a-open-label-study-to-evaluate-2-hpbcd-in-subjects-with-diabetic-kidney-disease?phase=2&page=2&id=226&slug=kidney-disease

P2a Open Label Study to Evaluate 2-HPβCD in Subjects ... This is a Phase 2a, open label, two to three center study to evaluate the clinical efficacy and safety of 1 dose level of 2-hydroxypropyl-β- ...

9. firstwordpharma.com firstwordpharma.com/story/5758764

European Patent Granted for ZyVersa Therapeutics' Lead ... Cholesterol Efflux Mediator™ VAR 200 (2-hydroxypropyl-beta-cyclodextrin, 2HPβCD) is a phase 2a-ready drug in development to ameliorate renal ...