ARG1 DeficiencyCLEARNCT07573059
Evaluation of the Safety of Loargys Arginine Test System in Loargys-treated Patients
A study testing Loargys Arginine Test System in people with ARG1 Deficiency, run by Immedica Pharma US Inc at 1 site in United States.
Trial summary
Arginase 1 deficiency (ARG1-D) is a rare condition in which the body cannot properly break down a substance called arginine. This leads to high levels of arginine and related substances in the blood, which can cause serious health problems and reduce quality of life. Read more about this study
- Who is it for?
- Ages 0 to 100 years
- Conditions the study is for
- ARG1 Deficiency
- What is being tested?
- Loargys Arginine Test System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2026to 15 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participant receiving treatment with commercialized Loargys for ARG1-D
- Participant is willing to sign the Informed Consent Form
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rare Disease Research
Atlanta, Georgia, 303029
CLEAR Study Coordinator, 678-883-6897, clear@rarediseaseresearch.com
About this study
Official title: A Multicenter, Prospective Study Assessing the Safety of Loargys Arginine Test System for Determining Arginine in Loargys-treated Patients
Arginase 1 deficiency (ARG1-D) is a rare condition in which the body cannot properly break down a substance called arginine. This leads to high levels of arginine and related substances in the blood, which can cause serious health problems and reduce quality of life.
Loargys is a new treatment designed to lower arginine levels in people with ARG1-D. It works by providing a modified version of a natural enzyme that breaks down arginine in the blood. The dose of Loargys is adjusted for each patient based on their arginine levels.
Read more
Because Loargys continues to break down arginine even after a blood sample has been taken, to ensure accurate results, a special substance (called nor-NOHA) is added to the blood collection tubes to stop this process after the sample is taken. The arginine levels are then measured using a standard laboratory test.
The Loargys Arginine Test System used in this study includes both the special blood collection tubes and the laboratory test used to measure arginine.
The purpose of this study is to evaluate the safety of this test system when used to measure arginine levels in patients receiving Loargys.
- Conditions
- ARG1 Deficiency
- Being tested
- Loargys Arginine Test System
- Medical subject headings
- Hyperargininemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loargys Arginine Test SystemDevice
Loargys Arginine Test System
| Study group | Role | What they receive |
|---|---|---|
| Loargys Arginine Test System | Other | Not described Receives: Device: Loargys Arginine Test System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs related to the Loargys Arginine Test System
Measured: Through study completion, up to 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start17 Apr 2026
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARG1 DeficiencyStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immedica Pharma US Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mattias Rudebeck, PhD, Study director, Immedica Pharma US Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573059
- Sponsor's protocol ID
- IMM-PEG-005
- Acronym
- CLEAR
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Study Assessing the Safety of Loargys Arginine Test System for Determining Arginine in Loargys-treated Patients
- ClinicalTrials.gov ID
- NCT07573059
- Acronym / sponsor ID
- CLEAR / IMM-PEG-005
- Conditions
- ARG1 Deficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Immedica Pharma US IncIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 7 May 2026 (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.
Arginase 1 deficiency (ARG1-D) is a rare condition in which the body cannot properly break down a substance called arginine. This leads to high levels of arginine and related substances in the blood, which can cause serious health problems and reduce quality of life.
Loargys is a new treatment designed to lower arginine levels in people with ARG1-D. It works by providing a modified version of a natural enzyme that breaks down arginine in the blood. The dose of Loargys is adjusted for each patient based on their arginine levels.
Because Loargys continues to break down arginine even after a blood sample has been taken, to ensure accurate results, a special substance (called nor-NOHA) is added to the blood collection tubes to stop this process after the sample is taken. The arginine levels are then measured using a standard laboratory test.
The Loargys Arginine Test System used in this study includes both the special blood collection tubes and the laboratory test used to measure arginine.
The purpose of this study is to evaluate the safety of this test system when used to measure arginine levels in patients receiving Loargys.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Loargys Arginine Test System | Other | Device: Loargys Arginine Test System |
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Participant receiving treatment with commercialized Loargys for ARG1-D
- Participant is willing to sign the Informed Consent Form
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Loargys Arginine Test SystemLoargys Arginine Test System | Device | Loargys Arginine Test System |
Primary outcome
Incidence of AEs related to the Loargys Arginine Test System
Time frame: Through study completion, up to 21 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Related InfoLink provided by the sponsor.
- 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.
Mattias Rudebeck, PhD study director
Immedica Pharma US Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loargys Arginine Test System in people with ARG1 Deficiency, run by Immedica Pharma US Inc at 1 site 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Head of Global Integrated Evidence Generation (+46(0)853339500, clinical@immedica.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AEs related to the Loargys Arginine Test System (time frame: Through study completion, up to 21 months). 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 7 May 2026.