Status:
COMPLETED
A Phase 2a Study of LLX-424 in Patients With a History of Kidney Stones
Lead Sponsor:
Lilac Therapeutics, Inc.
Conditions:
Kidney Stones
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ...
Detailed 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. Followin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06932146
Start Date
March 23 2025
End Date
September 30 2025
Last Update
October 29 2025
Active Locations (3)
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1
Clinical Research Site #2
Saint Paul, Minnesota, United States, 55114
2
Clinical Research Site #3
Springfield, Missouri, United States, 65802
3
Clinical Research Site #1
San Antonio, Texas, United States, 78217