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

Description

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.

Conditions

Kidney Stones

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Study Overview

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Study Details

Study 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.

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

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

Condition
Kidney Stones
Intervention / Treatment

-

Contacts and Locations

Saint Paul

Clinical Research Site #2, Saint Paul, Minnesota, United States, 55114

Springfield

Clinical Research Site #3, Springfield, Missouri, United States, 65802

San Antonio

Clinical Research Site #1, San Antonio, Texas, United States, 78217

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Lilac Therapeutics, Inc.,

Study Record Dates

2025-12-31