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Diabetic Kidney DiseasePhase 2NCT06489340

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

A Phase 2 study testing 2HPβCD in people with Diabetic Kidney Disease, run by ZyVersa Therapeutics, Inc. at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetic Kidney Disease
What is being tested?
2HPβCD
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
11 Jun 2025to 11 Aug 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Capable of giving and has provided a signed Informed Consent Form (ICF).
  • Male or female age 18 to 75 years inclusive, at the time of signing the informed consent.
  • Women of childbearing potential (WOCBP) and male subjects who are partners of WOCBP must agree to use an acceptable form of contraception during the study and for 30 days following the last dose of study drug.
  • Clinical diagnosis of type 2 diabetes as per guidelines.
  • Clinical diagnosis of diabetic kidney disease in the opinion of the principal investigator, or renal biopsy proven diabetic kidney disease without evidence of additional pathologic findings of alternative diagnosis.
  • At screening, based on two 24-hour urine collections, geometric mean of two urinary albumin creatine ratios (UACR) ≥ 400 mg/g and ≤ 3500 mg/g.
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  • At screening, eGFR equal or greater than 30 and less than 90 mL/min/1.73 m^2.
  • Body mass index (BMI) ≤ 40.0 kg/m^2.
  • If on diabetes and anti-hypertensive medications:
  • Angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) inhibitors dose must be stable for 3 months before screening.
  • Sodium-glucose co-transporter 2 (SGLT2) or GLP-1 receptor agonist or long-acting insulin dose must be stable for at least 3 months prior to screening.
  • All other diabetes and anti-hypertensive medications must be at a stable dose for at least 3 months prior to screening.
  • Hemoglobin A1c (HbA1c) ≤10.0% at screening.
  • Willing to comply with IV administration of the study drug for 12 weeks and all protocol procedures during the study.

Who cannot join

  • Has a solitary kidney.
  • Has a positive drug screen.
  • Known kidney disease other than diabetic kidney disease.
  • End stage renal disease (ESRD) (i.e., peritoneal dialysis, hemodialysis, or history of kidney transplantation).
  • Acute kidney injury or dialysis within the last 3 months before the screening visit.
  • Uncontrolled diabetes as defined by HbA1c >10 at screening.
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  • Uncontrolled hypertension with systolic blood pressure (SBP) >140 mmHg or diastolic blood pressure (DBP) >90 mmHg during screening.
  • Unstable cardiovascular disease or history of myocardial infarction or arterial thromboembolic events within 3 months prior to screening or severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease, or a QTc interval >480 msec.
  • Patients on IV medication containing cyclodextrin.
  • Patients on steroids, except for those on low-dose topical steroids (per PI discretion) or intranasal or inhaled steroids.
  • Surgery within the past 3 months prior to the first study drug administration determined by the Investigator to be clinically relevant.
  • Known malignancy that is progressing or has required active treatment within the past 3 years. Any exceptions must be approved by the Medical Monitor.
  • Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
  • Known history of Human Immunodeficiency Virus (HIV) infection (HIV 1/2 antibodies).
  • Known active Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
  • Diabetic ketosis, ketoacidosis and severe infections within a month or active infection requiring systemic therapy.
  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participants' participation for the full duration of the study, or is not in the best interest of the participants to participate in the opinion of the treating Investigator.
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
  • Women participants who are pregnant or breastfeeding or expecting to conceive children within the projected duration of the study or within 30 days of participation.
  • Aspartate aminotransferase (AST) or alanine transaminase (ALT) >3 upper limit of normal (ULN). One repeat test may be allowed within 7 days at the discretion of the Investigator.
  • Absolute neutrophil count ≤ 1.5 x 109/L at screening.
  • Platelets ≤ 100 x 109/L at screening.
  • Abnormal Hemoglobin (Hgb) (for men, abnormal levels are defined as <11.0 grams per deciliter (gm/dL) or >17.5 gm/dL. For women, < 10.0 gm/dL or >15.3 gm/dL.)
  • Currently participating or have participated in a study of an investigational product or used an investigational device within 3 months (or > 3 half-lives for mAbs with prolonged half-life of greater than 30 days) prior to the first dose of study intervention.
  • Patients on antibody therapeutics.
  • History or presence of alcohol or drug abuse within the 1 year prior to the first study drug administration.
  • A known history of otologic disease (e.g., Meniere's, sudden hearing loss, fluctuating hearing loss, vestibular schwannoma).
  • Pure tone air conduction thresholds in either ear at 3 consecutive frequencies > 60 dB at: 0.25, 0.5, 1, 2, 3, 4, 6, and 8 kHz.
  • Pure tone bone conduction thresholds > 60 dB in either ear that are 10 dB better than air conduction thresholds (i.e., air-bone gap > 10 dB) at all of the following frequencies: 0.5, 1, 2, and 4 kHz.
  • Use of non-steroidal anti-inflammatory drugs (NSAIDS) during the study period other than chronic low dose of aspirin stable for at least 3 months.
  • History of participation in a stem cell or gene therapy trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Clinical Advancement Center, PLLC

    San Antonio, Texas, 78212

Other trials in United States

About this study

Official title: 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)

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.

Read the 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.

Being tested
2HPβCD
Medical subject headings
Diabetic Nephropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2HPβCDDrug

    Also called 2-hydroxypropyl-β-cyclodextrin

    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.

Study groups in NCT06489340
Study groupRoleWhat they receive
2HPβCDExperimentalStudy drug will be administered by IV infusion during the treatment period.
Receives: Drug: 2HPβCD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change in 24-hour urinary albumin to creatinine ratio (UACR)

    Percentage change in urinary albumin to creatinine ratio (UACR) from baseline (day 1) to Week 12.

    Measured: From Day 1 (baseline) to Week 12 (end of treatment)

  2. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

    Number of adverse events (AEs), serious adverse events (SAEs), discontinuations over the 12-week treatment period

    Measured: 12 Weeks

Secondary outcomes (4)

  1. Absolute change in 24-hour urinary albumin to creatinine ratio (UACR)

    Absolute change in 24-hour urinary protein to creatinine ratio (UPCR) from baseline (Day 1) to Week 12 (end of treatment)

    Measured: From Day 1 (baseline) to Week 12 (end of treatment)

  2. Absolute change in 24-hour urinary protein to creatinine ratio (UPCR)

    Absolute change in log transformed 24 hour urinary protein to creatinine ratio (UPCR) from Day 1 (baseline) to Week 12 (end of treatment)

    Measured: From Day 1 (baseline) to Week 12 (end of treatment)

  3. Population trough pharmacokinetics of 2-hydroxypropyl-β-cyclodextrin (2-HPβCD)

    Trough plasma concentration of 2-hydroxypropyl-β-cyclodextrin (2-HPβCD) on Day 1, Day 29, Day 57, and Day 85, compared with pre-dosing concentrations on Day 1 and Day 4

    Measured: Day 1, Day 29, Day 57, Day 85

  4. Effects of 2-HPβCD on hearing based on changes in pure tone air conduction threshold from Day 1 to Week 16, and percent changes in tinnitus, and sense of fullness or stuffiness in the ears based on a Hearing Monitoring Questionnaire

    Changes in pure tone air conduction threshold based on audiometry testing from Day 1 to Week 16. Percent changes in the presence of tinnitus (ringing in the ears), and a sense of fullness or stuffiness in the ears based on responses to a Hearing Monitoring Questionnaire from Day 1 to Week 16

    Measured: From Day 1 to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2024
  2. Study start11 Jun 2025
  3. Primary completion11 Aug 2026 (estimated)
  4. Study completion11 Aug 2026 (estimated)

Why it stopped: Withdrawn due to patient enrollment challenges

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06489340
Sponsor's protocol ID
VAR200-0301
Status last verified
Sep 2025
First submitted
18 Jun 2024
Last updated
25 Nov 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 2HPβCD in people with Diabetic Kidney Disease, run by ZyVersa Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change in 24-hour urinary albumin to creatinine ratio (UACR) (time frame: From Day 1 (baseline) to Week 12 (end of treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06489340.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

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