NCT06489340

P2a Open Label Study to Evaluate 2-HPβCD in Subjects With Diabetic Kidney Disease

A Phase 2a Open Label Study to Evaluate Cholesterol Efflux Mediator™ VAR200: 2- Hydroxypropyl-β-cyclodextrin (2-HPβCD) in Subjects With Type 2 Diabetic Kidney Disease (DKD)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ZyVersa Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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 intravenously in adult patients with type 2 diabetes with diabetic kidney disease (DKD) and proteinuria.

Detailed description

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-HPβCD) given intravenously in adult patients with type 2 diabetes with diabetic kidney disease (DKD) and proteinuria. The study will be conducted at 2 - 3 sites in the United States of America (USA) and will screen a sufficient number of subjects to complete 8 participants meeting the inclusion/exclusion criteria outlined. The study consists of up to a 4-week screening period, a 12-week treatment period and a 4-week follow-up period.

Conditions

• Diabetic Kidney Disease

Interventions

Type	Name	Description
DRUG	2HPβCD	2HPβCD is a 7 D-glucopyranosyl derivation of cyclodextrin (CD) that entraps and passively removes intracellular cholesterol from the kidney. It is also believed to promote active cholesterol removal through up-regulation of cholesterol efflux transporters ABCA1 and ABCG1.

Timeline

• Start date: 2025-06-11
• Primary completion: 2026-08-11
• Completion: 2026-08-11
• First posted: 2024-07-05
• Last updated: 2025-11-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study