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

Lilac Therapeutics, Inc.

Status and phase: Enrolling; Phase 2

Conditions: Kidney Stones

Treatments: Drug: LLX-424

Study type: Interventional

Funder types: Industry

Identifiers

NCT06932146

LLX-002

Details and patient eligibility

About

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.

Full 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).

Enrollment: 51 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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51 participants in 2 patient groups, including a placebo group

LLX-424

Experimental group

Description:

Tablets for oral administration

Treatment:

Drug: LLX-424

Placebo

Placebo Comparator group

Description:

Tablets for oral administration

Treatment:

Drug: LLX-424