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

Lilac Therapeutics, Inc.51 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Kidney Stones

Interventions

LLX-424DRUG

Tablets for oral administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (3)

Clinical Research Site #2

Saint Paul, Minnesota, United States

Clinical Research Site #3

Springfield, Missouri, United States

Clinical Research Site #1

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Treatment-emergent adverse events (TEAEs)

Percentage of subjects with TEAEs

Time frame: 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

Time frame: 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

Time frame: From the first dose and for up to 9 weeks

Secondary Outcomes

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

Comparison between LLX-424 group and the placebo group

Time frame: From pre-dose to Study Day 56

Peak plasma concentration (Cmax) of LLX-424

Cmax of plasma LLX-424

Time frame: From pre-dose to Study Day 56

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

AUC of plasma LLX-424

Time frame: From pre-dose to Study Day 56

Peak plasma concentration (Cmax) of glycolate

Cmax of plasma glycolate

Time frame: From pre-dose to Study Day 56

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

AUC of plasma glycolate

Data from ClinicalTrials.gov

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