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NCT Number: NCT06932146

A Phase 2a Study of LLX-424 in Patients With a History of Kidney Stones

This is a Phase 2a study of glycolate oxidase inhibitor LLX-424 in patients with a history of kidney stones. Eligible subjects with a history of kidney stones will be randomized to receive study drug (LLX-424 or placebo) for 8 weeks.

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Key information

Conditions

Kidney Stones Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Research Site #2, Saint Paul, Minnesota, United States

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About this study

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 with a history of kidney stones.

Following completion of screening procedures, on Study Day 1, eligible subjects will be randomized in a 2:1 ratio to receive either LLX-424 or matching placebo, respectively.

An outpatient safety Follow-up Visit will be scheduled on Day 63 or 7 days after the last dose (end of study visit).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Estimated glomerular filtration rate ≥ 60 mL/min/1.73m2

Exclusion criteria

  • History or medical record evidence of kidney stones that are not calcium oxalate
  • Unstable kidney function
  • Spot urine protein to creatinine ratio ≥ 1 mg/mg at screening
  • History of kidney transplantation
  • Hemoglobin A1c > 9.5% at screening
  • History of enteric hyperoxaluria, intestinal malabsorption, bariatric surgery, intestinal surgery, inflammatory bowel disease
  • History or evidence of cirrhosis

Treatment and study plan

LLX-424

Drug

Tablets for oral administration

Other names: glycolate oxidase inhibitor

Primary outcomes

  1. Treatment-emergent adverse events (TEAEs)

    Time frame: From the first dose and for up to 9 weeks

    Percentage of subjects with TEAEs

  2. Percentage of subjects with study drug-related severe laboratory-based AEs

    Time frame: From the first dose and for up to 9 weeks

    Laboratory-based adverse events

  3. QT interval on ECG

    Time frame: From the first dose and for up to 9 weeks

    Percentage of subjects with an increase from baseline in the QTcF by > 60 milliseconds

Secondary outcomes

  1. Mean change from baseline in 24-hour urine oxalate excretion rate

    Time frame: From pre-dose to Study Day 56

    Comparison between LLX-424 group and the placebo group

  2. Peak plasma concentration (Cmax) of LLX-424

    Time frame: From pre-dose to Study Day 56

    Cmax of plasma LLX-424

  3. Area under the curve (AUC) of plasma LLX-424 concentration versus time after dosage

    Time frame: From pre-dose to Study Day 56

    AUC of plasma LLX-424

  4. Peak plasma concentration (Cmax) of glycolate

    Time frame: From pre-dose to Study Day 56

    Cmax of plasma glycolate

  5. Area under the curve (AUC) of plasma glycolate concentration versus time after dosage

    Time frame: From pre-dose to Study Day 56

    AUC of plasma glycolate

Sponsors and collaborators

Lead sponsor

Lilac Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 2a Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamic (PD) Effects of LLX-424 in Patients With a History of Kidney Stones

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 17, 2025
Registry last updated
Oct 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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