NCT06547151

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: Amorphical Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

AMOR-1 contains Amorphous Calcium Carbonate (ACC) nanoparticles, which provide higher calcium absorption and bioavailability compared to the crystalline form. Therefore, significantly smaller doses of elemental calcium provided by ACC may be sufficient to maintain the desired serum calcium levels in people with hypoparathyroidism. The lower calcium doses can potentially reduce the adverse effects, associated with long-term, high daily doses of calcium supplementation, consumed by these patients. The main question for the study is: Can replacing the current calcium supplement with AMOR-1, which contains half the amount of elemental calcium, maintain blood calcium levels in people with hypoparathyroidism? Patients with a history of hypoparathyroidism will be randomized in a 2:1 ratio to receive either AMOR-1 or Control (the conventional crystalline calcium carbonate supplement), respectively. Their current dose of calcium supplement will be gradually replaced with AMOR-1 or the Control over 2-4 weeks. At the end of the replacement phase, participants in the AMOR-1 arm are anticipated to receive 50% of the elemental calcium compared to their initial intake from the crystalline calcium supplements. Subjects in the Control arm will maintain their initial elemental calcium intake. Following this replacement phase, the participants will continue receiving their individual dose of AMOR-1 or the Control for an additional 10-12 weeks (Dose Maintenance phase). At the end of this phase, the participants will revert to their initial calcium supplement and will be monitored for an additional month until the end of the study. All participants will receive an active form of vitamin D in parallel to the study treatment. Throughout the study, participants will be routinely monitored for safety and efficacy, including calcium levels in the blood and urine.

Conditions

• Hypoparathyroidism

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-15
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2024-08-09
• Last updated: 2025-09-04

Locations

8 sites across 1 country: Israel

Regulatory

• FDA-regulated drug study