Kidney StonesPhase 2NCT06932146
A Phase 2a Study of LLX-424 in Patients With a History of Kidney Stones
A Phase 2 study testing LLX-424 in people with Kidney Stones, run by Lilac Therapeutics, Inc. at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Stones
- What is being tested?
- LLX-424
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Mar 2025to 30 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Clinical Research Site #2
Saint Paul, Minnesota, 55114
Clinical Research Site #1
San Antonio, Texas, 78217
Clinical Research Site #3
Springfield, Missouri, 65802
About this study
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
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.
Read the detailed 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).
- Conditions
- Kidney Stones
- Being tested
- LLX-424
- Keywords
- oxalate, glycolate oxidase
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLX-424Drug
Also called glycolate oxidase inhibitor
Tablets for oral administration
| Study group | Role | What they receive |
|---|---|---|
| LLX-424 | Experimental | Tablets for oral administration Receives: Drug: LLX-424 |
| Placebo | Placebo comparator | Tablets for oral administration Receives: Drug: LLX-424 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events (TEAEs)
Percentage of subjects with TEAEs
Measured: 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
Measured: 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
Measured: From the first dose and for up to 9 weeks
Secondary outcomes (5)
Mean change from baseline in 24-hour urine oxalate excretion rate
Comparison between LLX-424 group and the placebo group
Measured: From pre-dose to Study Day 56
Peak plasma concentration (Cmax) of LLX-424
Cmax of plasma LLX-424
Measured: 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
Measured: From pre-dose to Study Day 56
Peak plasma concentration (Cmax) of glycolate
Cmax of plasma glycolate
Measured: From pre-dose to Study Day 56
Area under the curve (AUC) of plasma glycolate concentration versus time after dosage
AUC of plasma glycolate
Measured: From pre-dose to Study Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start23 Mar 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lilac Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932146
- Sponsor's protocol ID
- LLX-002
- Status last verified
- Oct 2025
- First submitted
- 2 Apr 2025
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06932146
- Acronym / sponsor ID
- LLX-002
- Conditions
- Kidney Stones
- Keywords
- oxalate, glycolate oxidase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Lilac Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLX-424 | Experimental | Drug: LLX-424Tablets for oral administration |
| Placebo | Placebo comparator | Drug: LLX-424Tablets for oral administration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LLX-424Also: glycolate oxidase inhibitorTablets for oral administration | Drug | LLX-424, Placebo |
Primary outcome
Treatment-emergent adverse events (TEAEs)
Time frame: From the first dose and for up to 9 weeks
Percentage of subjects with TEAEs
Percentage of subjects with study drug-related severe laboratory-based AEs
Time frame: From the first dose and for up to 9 weeks
Laboratory-based adverse events
QT interval on ECG
Time frame: From the first dose and for up to 9 weeks
Percentage of subjects with an increase from baseline in the QTcF by > 60 milliseconds
5 secondary outcomes
Mean change from baseline in 24-hour urine oxalate excretion rate
Time frame: From pre-dose to Study Day 56
Peak plasma concentration (Cmax) of 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
Time frame: From pre-dose to Study Day 56
Peak plasma concentration (Cmax) of glycolate
Time frame: From pre-dose to Study Day 56
Area under the curve (AUC) of plasma glycolate concentration versus time after dosage
Time frame: From pre-dose to Study Day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LLX-424 in people with Kidney Stones, run by Lilac Therapeutics, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events (TEAEs) (time frame: From the first dose and for up to 9 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.