Evaluation of the Safety of Loargys Arginine Test System in Loargys-treated Patients
Immedica Pharma US Inc · NCT07573059
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 0 mo–100 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 100
- US sites recruiting
- 1
- Study start
- April 17, 2026
- Record last updated
- May 7, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Loargys Arginine Test System
Conditions: ARG1 Deficiency
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Participant receiving treatment with commercialized Loargys for ARG1-D
- Participant is willing to sign the Informed Consent Form
Exclusion Criteria
- None
Recruiting US locations
Rare Disease Research
Atlanta, GA 303029
Site contact: CLEAR Study Coordinator · 678-883-6897 · clear@rarediseaseresearch.com
Study contacts (from the official record)
- Head of Global Integrated Evidence Generation · +46(0)853339500 · clinical@immedica.com