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

Launched by LILAC THERAPEUTICS, INC. · Apr 9, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new medication called LLX-424 to see if it can help prevent kidney stones in people who have had them before. The study will last for 8 weeks, and participants will be randomly assigned to receive either the study drug or a placebo (a harmless pill that looks like the drug but has no active ingredients). The goal is to find out if LLX-424 can lower the risk of future kidney stones.

To be eligible for this trial, participants should have a documented history of kidney stones and meet certain health criteria, such as having a specific range for body weight and kidney function. People between the ages of 18 and 75 can participate, as long as they don’t have certain conditions like unstable kidney function or a history of specific gastrointestinal issues. If you join the study, you’ll be monitored closely and will have the chance to help researchers learn more about kidney stones and how to prevent them in the future.

Gender

ALL

Eligibility criteria

• 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