RecruitingPhase 2NCT06547151

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

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.

Sponsor

Amorphical Ltd.

Enrollment

81 participants

Start Date

Dec 15, 2024

Study Type

INTERVENTIONAL

Conditions

Hypoparathyroidism

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AMOR-1 and a drug called Crystalline Calcium Carbonate for people with hypoparathyroidism. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAMOR-1

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

DRUGCrystalline 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06547151

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