Actively Recruiting

Phase 1
Age: 0 - 1Year
All Genders
NCT05734196

The ENERGY Study: Evaluation of Safety and Tolerability of INZ-701 in Infants With ENPP1 Deficiency or ABCC6 Deficiency

Led by Inozyme Pharma · Updated on 2026-03-24

16

Participants Needed

7

Research Sites

228 weeks

Total Duration

On this page

Sponsors

I

Inozyme Pharma

Lead Sponsor

B

BioMarin Pharmaceutical

Collaborating Sponsor

AI-Summary

What this Trial Is About

The primary purpose of Study INZ701-104 (the ENERGY study) is to assess the safety and tolerability of INZ-701 in infants with ENPP1 Deficiency or with ABCC6 Deficiency.

CONDITIONS

Official Title

The ENERGY Study: Evaluation of Safety and Tolerability of INZ-701 in Infants With ENPP1 Deficiency or ABCC6 Deficiency

Who Can Participate

Age: 0 - 1Year
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infant aged 64 1 year at the time of enrollment
  • Confirmed post-natal molecular genetic diagnosis of ENPP1 Deficiency or ABCC6 Deficiency
  • Clinical signs of generalized arterial calcification of infancy (GACI) or GACI-2 including ectopic calcification, heart failure, respiratory distress, edema, cyanosis, hypertension, or cardiomegaly
  • Infant weighs 64 0.5 kg at first dose of INZ-701
  • Written informed consent from parent or legal guardian
Not Eligible

You will not qualify if you...

  • Any clinically significant disease or lab abnormality that prevents participation or affects study results, per Investigator
  • Receiving end of life or hospice care
  • Known cancer
  • Participation in another non-Inozyme interventional study
  • Treatment with any non-Inozyme product or investigational device during study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Rady Children's Hospital

San Diego, California, United States, 92123

Actively Recruiting

2

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Withdrawn

3

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Actively Recruiting

4

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

5

The University of Utah

Salt Lake City, Utah, United States, 84108

Withdrawn

6

Hospital Sant Joan de Déu

Barcelona, Spain

Terminated

7

Royal Manchester Children's Hospital

Manchester, United Kingdom, M13 9WL

Terminated

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Research Team

T

Trial Specialist

CONTACT

M

Medical Director, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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