NCT06932146

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Lilac Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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. 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).

Conditions

• Kidney Stones

Interventions

Type	Name	Description
DRUG	LLX-424	Tablets for oral administration

Timeline

• Start date: 2025-03-23
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2025-04-17
• Last updated: 2025-10-29

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study