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The ENERGY 3 Study: Evaluation of Efficacy and Safety of INZ-701 in Children With ENPP1 Deficiency

NCT06046820 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-05-01

No results posted yet for this study

Summary

The primary purpose of Study INZ701-106 (The ENERGY 3 Study) is to assess the efficacy and safety of INZ-701 in children with ENPP1 Deficiency.

Conditions

  • Ectonucleotide Pyrophosphatase/Phosphodiesterase1 Deficiency
  • Autosomal Recessive Hypophosphatemic Rickets
  • Generalized Arterial Calcification of Infancy

Interventions

DRUG

INZ-701

Recombinant fusion protein that contains the extracellular domains of human ENPP1 coupled with an Fc fragment from an immunoglobulin gamma-1 (IgG1) antibody.

DRUG

Control Arm (Conventional Therapy)

Conventional therapy is defined as oral phosphate supplements and calcitriol or other active forms of vitamin D3 (or analogs). No other agents for treatment of ENPP1 Deficiency are allowed in the control arm.

Sponsors & Collaborators

  • Inozyme Pharma

    lead INDUSTRY

Principal Investigators

  • Kurt Gunter, MD · Inozyme Pharma, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-05
Primary Completion
2026-01-31
Completion
2026-02-28
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Saudi Arabia
  • Spain
  • Turkey (Türkiye)
  • United Arab Emirates
  • United Kingdom

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 NCT06046820 on ClinicalTrials.gov