NCT07573059 Evaluation of the Safety of Loargys Arginine Test System in Loargys-treated Patients
| NCT ID | NCT07573059 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Immedica Pharma US Inc |
| Condition | ARG1 Deficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-04-17 |
| Primary Completion | 2027-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-04-17 with a primary completion date of 2027-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * Participant receiving treatment with commercialized Loargys for ARG1-D * Participant is willing to sign the Informed Consent Form Exclusion Criteria: * None
Contact & Investigator
Mattias Rudebeck, PhD
STUDY DIRECTOR
Immedica Pharma US Inc
Frequently Asked Questions
Who can join the NCT07573059 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 100 Years, studying ARG1 Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07573059 currently recruiting?
Yes, NCT07573059 is actively recruiting participants. Contact the research team at clinical@immedica.com for enrollment information.
Where is the NCT07573059 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT07573059 clinical trial?
NCT07573059 is sponsored by Immedica Pharma US Inc. The principal investigator is Mattias Rudebeck, PhD at Immedica Pharma US Inc. The trial plans to enroll 100 participants.