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

NCT07573059 | Recruiting FDA Device

• 1 other identifier: IMM-PEG-005
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

ARG1 Deficiency

Outcome Measures

Primary Outcomes (1)

• Incidence of AEs related to the Loargys Arginine Test System

  Through study completion, up to 21 months

Study Arms (1)

Loargys Arginine Test System

OTHER

Device: Loargys Arginine Test System

Interventions

Loargys Arginine Test System DEVICE

Loargys Arginine Test System

Loargys Arginine Test System

Eligibility Criteria

• Age: 0 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant receiving treatment with commercialized Loargys for ARG1-D
• Participant is willing to sign the Informed Consent Form

You may not qualify if:

• None

Sponsors & Collaborators

• Immedica Pharma US Inc: lead

Study Sites (1)

Rare Disease Research

Atlanta, Georgia, 303029, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Hyperargininemia

Condition Hierarchy (Ancestors)

Urea Cycle Disorders, Inborn; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mattias Rudebeck, PhD

  Immedica Pharma US Inc

  STUDY DIRECTOR

Central Study Contacts

Head of Global Integrated Evidence Generation

CONTACT

+46(0)853339500; clinical@immedica.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 7, 2026
• Study Start: April 17, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)