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

NCT06489340 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-11-25

No results posted yet for this study

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.

Conditions

  • Diabetic Kidney Disease

Interventions

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.

Sponsors & Collaborators

  • ZyVersa Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Pablo Pergola, M.D PHD · Clinical Advancement Center, PLLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-11
Primary Completion
2026-08-11
Completion
2026-08-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06489340 on ClinicalTrials.gov