COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-03-23
Study Completion:2025-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06932146

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * History of kidney stones documented in medical records
  2. * 24-hour urine oxalate excretion
  3. * Body mass index 18.5 to 38 kg/m2 inclusive
  4. * Estimated glomerular filtration rate ≥ 60 mL/min/1.73m2
  1. * History or medical record evidence of kidney stones that are not calcium oxalate
  2. * Unstable kidney function
  3. * Spot urine protein to creatinine ratio ≥ 1 mg/mg at screening
  4. * History of kidney transplantation
  5. * Hemoglobin A1c \> 9.5% at screening
  6. * History of enteric hyperoxaluria, intestinal malabsorption, bariatric surgery, intestinal surgery, inflammatory bowel disease
  7. * History or evidence of cirrhosis

Contacts and Locations

Study Locations (Sites)

Clinical Research Site #2
Saint Paul, Minnesota, 55114
United States
Clinical Research Site #3
Springfield, Missouri, 65802
United States
Clinical Research Site #1
San Antonio, Texas, 78217
United States

Collaborators and Investigators

Sponsor: Lilac Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-23
Study Completion Date2025-09-30

Study Record Updates

Study Start Date2025-03-23
Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

  • oxalate
  • glycolate oxidase

Additional Relevant MeSH Terms

  • Kidney Stones