A Phase 2a Study of LLX-424 in Patients With a History of Kidney Stones
NCT ID: NCT06932146
Last Updated: 2025-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
51 participants
INTERVENTIONAL
2025-03-23
2025-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LLX-424
Tablets for oral administration
LLX-424
Tablets for oral administration
Placebo
Tablets for oral administration
LLX-424
Tablets for oral administration
Interventions
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LLX-424
Tablets for oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Lilac Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Related Links
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Sponsor website
Other Identifiers
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LLX-002
Identifier Type: -
Identifier Source: org_study_id
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