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Evaluating the Safety and Efficacy of AMOR-1 as a Treatment for Hypocalcemia Associated With Hypoparathyroidism in Adults

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 23% 81 → 62 participants
See other at-risk trials from Amorphical Ltd.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates: Jun 30, 2026 to Dec 30, 2026
    • Sponsor refiled this as active, not recruiting (was completed)
    v6
  2. Trial completed
    • Enrollment reduced: 81 → 62 participants
    • Primary and study completion moved earlier from Sep 2026 to Jun 30, 2026
    • Study sites: 8 to 9
    v5
  3. Study sites: 6 to 8
    • Eligibility criteria expanded, about 115 words
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 5 to 6
    • Start date changed from estimate of Nov 2024 to Dec 15, 2024
    v3
  5. Start date: Sep 2024 to Nov 2024
    • Study sites: 1 to 5
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This clinical trial aims to evaluate the efficacy and safety of AMOR-1, consisting of Amorphous Calcium Carbonate (ACC) as the active drug substance, in treating hypocalcemia in adults with hypoparathyroidism.
Trial Details
NCT Number NCT06547151
Lead Sponsor Amorphical Ltd.
Conditions
(from sponsor)		 Hypoparathyroidism
Related terms Hypocalcemia, Hypoparathyroidism
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov