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

NCT06932146 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: LLX-002
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Kidney Stones

Keywords

oxalate; glycolate oxidase

Outcome Measures

Primary Outcomes (3)

• Treatment-emergent adverse events (TEAEs)

  Percentage of subjects with TEAEs

  From the first dose and for up to 9 weeks

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

  Laboratory-based adverse events

  From the first dose and for up to 9 weeks

• QT interval on ECG

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

  From the first dose and for up to 9 weeks

Secondary Outcomes (5)

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

  From pre-dose to Study Day 56

• Peak plasma concentration (Cmax) of LLX-424

  From pre-dose to Study Day 56

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

  From pre-dose to Study Day 56

• Peak plasma concentration (Cmax) of glycolate

  From pre-dose to Study Day 56

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

  From pre-dose to Study Day 56

Study Arms (2)

LLX-424

EXPERIMENTAL

Tablets for oral administration

Drug: LLX-424

Placebo

PLACEBO COMPARATOR

Tablets for oral administration

Drug: LLX-424

Interventions

LLX-424 DRUG

Tablets for oral administration

Also known as: glycolate oxidase inhibitor

LLX-424; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of kidney stones documented in medical records
• hour urine oxalate excretion
• Body mass index 18.5 to 38 kg/m2 inclusive
• Estimated glomerular filtration rate ≥ 60 mL/min/1.73m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Lilac Therapeutics, Inc.: lead

Study Sites (3)

Clinical Research Site #2

Saint Paul, Minnesota, 55114, United States

Location

Clinical Research Site #3

Springfield, Missouri, 65802, United States

Location

Clinical Research Site #1

San Antonio, Texas, 78217, United States

Location

Related Links

• Sponsor website

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 17, 2025
• Study Start: March 23, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)