LLX-424 for Kidney Stones

No longer recruiting at 2 trial locations

Overseen By Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Lilac Therapeutics, Inc.

Disqualifiers: Unstable kidney function, Kidney transplant, Cirrhosis, others

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

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LLX-424, a potential drug for individuals with a history of kidney stones. The focus is on reducing kidney stone formation by comparing LLX-424 to a placebo over 8 weeks. Individuals with calcium oxalate kidney stones and stable kidney function may be suitable candidates. The goal is to determine if LLX-424 can prevent future kidney stones. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that LLX-424 is likely to be safe for humans?

Research has shown that LLX-424 could help treat kidney stones. In studies, most participants tolerated LLX-424 well, experiencing no serious side effects. Further testing is underway to ensure its safety for a larger population. If LLX-424 performs as expected, it might prevent kidney stones by altering urine chemistry. Although LLX-424 remains under investigation, its safety profile so far supports continued research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for kidney stones, which often include pain relievers, alpha blockers, and sometimes surgical procedures, LLX-424 offers a new approach. Researchers are excited about LLX-424 because it introduces an innovative mechanism of action that may help dissolve kidney stones more effectively. This oral tablet targets stone formation processes directly, potentially offering a non-invasive and convenient alternative to current options. If successful, LLX-424 could significantly reduce the need for more invasive interventions, making it a promising advancement for individuals suffering from kidney stones.

What evidence suggests that LLX-424 might be an effective treatment for kidney stones?

Studies have shown that LLX-424 helps by stopping the liver from producing oxalate, a substance that can lead to kidney stones. Early results suggest that LLX-424 can lower oxalate levels in the body, potentially reducing the risk of developing new kidney stones. This trial will test LLX-424 as a promising option for individuals who frequently experience kidney stones. Initial research also indicates that using LLX-424 with potassium citrate increases beneficial substances like urinary citrate and total urine volume, which can further prevent stones. While more research is needed, these findings offer hope for those seeking to avoid future kidney stones. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for people who have had kidney stones before. Participants will be randomly assigned to receive either the study drug LLX-424 or a placebo for 8 weeks.

Inclusion Criteria

History of kidney stones documented in medical records

24-hour urine oxalate excretion

Body mass index 18.5 to 38 kg/m2 inclusive

Exclusion Criteria

I have had a kidney transplant.

History or medical record evidence of kidney stones that are not calcium oxalate

Spot urine protein to creatinine ratio ≥ 1 mg/mg at screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LLX-424 or placebo for 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (outpatient)

What Are the Treatments Tested in This Trial?

Interventions

• LLX-424

Trial Overview The trial is testing LLX-424, which is a glycolate oxidase inhibitor, to see if it can help prevent the formation of kidney stones in patients with a history of this condition.

How Is the Trial Designed?

Group I: LLX-424 Experimental Treatment 1 Intervention

Tablets for oral administration

Group II: Placebo Placebo Group 1 Intervention

Tablets for oral administration

Who Is Running the Clinical Trial?

Lilac Therapeutics, Inc.

Lead Sponsor

Published Research Related to This Trial

Lemonade therapy (LT) alone significantly increased urinary citrate and total urine volume in patients with calcium oxalate stone formation, with a maximum increase of 203 mg/day in urinary citrate and 763 mL/day in urine volume.

When combined with potassium citrate, LT was even more effective, resulting in a greater increase in urinary citrate (346 mg/day) and total urine volume (860 mL/day), highlighting the potential for enhanced treatment strategies for preventing stone formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lemonade therapy increases urinary citrate and urine volumes in patients with recurrent calcium oxalate stone formation. Penniston, KL., Steele, TH., Nakada, SY.[2013]

In a study involving five calcium oxalate stone formers, the ingestion of minimum doses of potassium citrate significantly increased citraturia and crystallization inhibitory capacity in urine samples.

The most effective timing for taking potassium citrate was after dinner, suggesting that this method could help reduce the risk of kidney stone formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronopharmacological studies on potassium citrate treatment of oxalocalcic urolithiasis. Grases, F., Conte, A., March, JG., et al.[2019]

Citations

1. austinurologyinstitute.com austinurologyinstitute.com/blog/kidney-stone-patients-consider-a-clinical-study/

Kidney Stone Patients: Consider a Clinical Study Here's the science behind the treatment: LLX-424 is designed to block the production of oxalate in the liver, reducing the amount of oxalate in ...

2. trialx.com trialx.com/clinical-trials/listings/296752/a-phase-2a-study-of-llx-424-in-patients-with-a-history-of-kidney-stones/

A Phase 2a Study of LLX-424 in Patients With a History ... Overview. This is a Phase 2a study of glycolate oxidase inhibitor LLX-424 in patients with a history of kidney stones.

3. withpower.com withpower.com/trial/phase-2-kidney-calculi-2-2025-c3106

LLX-424 for Kidney Stones · Info for Participants When combined with potassium citrate, LT was even more effective, resulting in a greater increase in urinary citrate (346 mg/day) and total urine volume (860 mL ...

4. malacards.org malacards.org/card/nephrolithiasis_x_linked_recessive_with_renal_failure

Nephrolithiasis, X-Linked Recessive, with Renal Failure ... LLX-424 in Patients With a History of Kidney Stones, Recruiting, NCT06932146 ... Trial Comparing Surgical Outcomes Following PCNL and Mini PCNL in the Treatment ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06932146

A Phase 2a Study of LLX-424 in Patients With a History ... This is a Phase 2a, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, PK, and PD effects of LLX-424 in patients ...

6. journals.lww.com journals.lww.com/10.1681/ASN.20259wn27qr9

and Multiple-Dose Administration of LLX-424, a Glycolate ... The safety, tolerability, PK, and PD of LLX-424 supports further clinical evaluation in patients with recurrent kidney stones.