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RECRUITING
NCT06547151
PHASE2

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

Sponsor: Amorphical Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase 2, Prospective, Multinational, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of AMOR-1 as a Treatment of Hypocalcemia Associated With Hypoparathyroidism by Replacement of Currently Used Calcium Supplements (CS) in Adults.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

81

Start Date

2024-12-15

Completion Date

2026-09

Last Updated

2025-09-04

Healthy Volunteers

No

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.

Locations (8)

Assuta Ashdod medical center

Ashdod, Israel, Israel

Hadassah Ein Kerem Medical Center

Jerusalem, Israel, Israel

Rabin Medical Center, Belinson Campus

Petah Tikva, Israel, Israel

Barzilai Medical Center

Ashkelon, Israel

Soroka Medical Center

Beersheba, Israel

Rambam Medical Center

Haifa, Israel

Sheba Medical Center

Ramat Gan, Israel

Kaplan Medical Center

Rehovot, Israel