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

Last updated: April 28, 2025
Sponsor: Lilac Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Kidney Stones

Treatment

LLX-424

Clinical Study ID

NCT06932146
LLX-002
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 51
Treatment Group(s): 1
Primary Treatment: LLX-424
Phase: 2
Study Start date:
March 23, 2025
Estimated Completion Date:
December 31, 2025

Study Description

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).

Connect with a study center

  • Clinical Research Site #2

    Saint Paul, Minnesota 55114
    United States

    Active - Recruiting

  • Clinical Research Site #3

    Springfield, Missouri 65802
    United States

    Active - Recruiting

  • Clinical Research Site #1

    San Antonio, Texas 78217
    United States

    Active - Recruiting

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