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

Study acronym: ENERGY
StatusTerminated
PhasePhase 1
Started
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Record History

See every version on ClinicalTrials.gov ↗

  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.
    • Final enrollment: 9 participants (planned 16)
    • Primary and study completion dates changed from estimate of Oct 14, 2026 to Sep 29, 2026
  2. Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Site details revised at 4 of 5 sites
  3. Primary and study completion moved earlier from Nov 11, 2027 to Oct 14, 2026
    • Enrollment closed, study ongoing
    • Study sites: 7 to 5
    v10
  4. Primary completion date: Mar 1, 2026 to Nov 11, 2027v9 Show 4 more changesShow less
    • Study completion date: Apr 1, 2026 to Nov 11, 2027
    • Eligibility criteria shortened, about 160 words
    • Site details revised at 6 of 7 sites
    • Collaborators expanded, about 2 words
  5. Site contacts updated at 1 of 7 sitesv8
Show 6 earlier versionsHide 6 earlier versions
  1. Enrollment target: 8 to 16v7 Show 7 more changesShow less
    • Primary completion date: Mar 1, 2025 to Mar 1, 2026
    • Start date: May 25, 2023 to Jun 25, 2023
    • Study sites: 6 to 7
    • Study completion date: Apr 1, 2025 to Apr 1, 2026
    • Eligibility criteria expanded, about 35 words
    • Study description shortened, about 8 words
    • Study title expanded, about 3 words
  2. Study sites: 4 to 6v6
  3. Study sites: 3 to 4
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description expanded, about 35 words
    v5
  4. Study sites: 2 to 3v4
  5. Start date changed from estimate of May 1, 2023 to May 25, 2023
    • Secondary endpoints: details revised at 1 of 4 entries
    v3
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date: Mar 2023 to May 1, 2023
    • Study sites: 0 to 2
    • Primary completion date: Dec 2024 to Mar 1, 2025
    • Study completion date: Dec 2025 to Apr 1, 2025
  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 INZ701-104 (the ENERGY study) is to assess the safety and tolerability of INZ-701 in infants with ENPP1 Deficiency or with ABCC6 Deficiency.
Trial Details
NCT Number NCT05734196
Lead Sponsor Inozyme Pharma
Collaborators: BioMarin Pharmaceutical
Conditions
(from sponsor)		 Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency, Autosomal Recessive Hypophosphatemic Rickets, Generalized Arterial Calcification of Infancy, ATP-Binding Cassette Subfamily C Member 6 Deficiency, Pseudoxanthoma Elasticum
Related terms Arterial calcification of infancy, Hypophosphatemic Rickets, Autosomal Recessive, 1, Pseudoxanthoma Elasticum
Enrollment 9 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov