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

NCT06547151 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2025-09-04

No results posted yet for this study

Summary

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.

Conditions

  • Hypoparathyroidism

Interventions

DRUG

AMOR-1

Investigational arm: Tablets containing 250mg elemental calcium from Amorphous Calcium Carbonate (ACC).

DRUG

Crystalline Calcium Carbonate

Control arm: Crystalline Calcium Carbonate (CCC) oral tablet contains 500 mg elemental calcium.

Sponsors & Collaborators

  • Amorphical Ltd.

    lead INDUSTRY

Principal Investigators

  • Ilan Shimon, MD · Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-15
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • Israel

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 NCT06547151 on ClinicalTrials.gov