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

StatusTerminated
PhasePhase 3
Started
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Record History

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  1. Trial terminated Sponsor's reason: The study was terminated by the sponsor prior to planned completion based on a review of the data across indications and overall program considerations. Study termination was not related to participant safety. Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Trial sites reduced: 15 → 11 locations
    • Study completion date changed from estimate of Feb 2026 to Aug 19, 2026
    • Primary completion date changed from estimate of Jan 2026 to Jan 29, 2026
    • Eligibility criteria expanded, about 65 words
    • Secondary endpoints: 6 to 5
    • Collaborators expanded, about 2 words
  2. Primary completion date: May 2025 to Jan 2026v8 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 33 to confirmed 27
    • Study sites: 11 to 15
    • Study completion date: Jun 2025 to Feb 2026
  3. Site contacts updated at 1 of 11 sitesv7
  4. Study sites: 5 to 11v6
  5. Study sites: 3 to 5v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 1 to 3
    • Start date changed from estimate of Jan 12, 2024 to Nov 5, 2023
    v4
  2. Start date: Sep 22, 2023 to Jan 12, 2024v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06046820
Lead Sponsor Inozyme Pharma
Collaborators: BioMarin Pharmaceutical
Conditions
(from sponsor)		 Ectonucleotide Pyrophosphatase/Phosphodiesterase1 Deficiency, Autosomal Recessive Hypophosphatemic Rickets, Generalized Arterial Calcification of Infancy
Related terms Arterial calcification of infancy, Hypophosphatemic Rickets, Autosomal Recessive, 1
Enrollment 27 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov