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Evaluation of the Safety of Loargys Arginine Test System in Loargys-treated Patients

NCT07573059 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-07

No results posted yet for this study

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.

Conditions

  • ARG1 Deficiency

Interventions

DEVICE

Loargys Arginine Test System

Loargys Arginine Test System

Sponsors & Collaborators

  • Immedica Pharma US Inc

    lead INDUSTRY

Principal Investigators

  • Mattias Rudebeck, PhD · Immedica Pharma US Inc

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-17
Primary Completion
2027-07-15
Completion
2027-07-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07573059 on ClinicalTrials.gov