Evaluating the Safety and Efficacy of AMOR-1 as a Treatment for Hypocalcemia Associated With Hypoparathyroidism in Adults
NCT Number: NCT06547151
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hypoparathyroidism
Interventions: DRUG: AMOR-1|DRUG: Crystalline Calcium Carbonate
Sponsor: Amorphical Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 81
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-09
Locations: Rabin Medical Center, Belinson Campus, Petah tikva, 49100, Israel

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.

Primary Outcome Measures: Percentage of Subjects Who Achieved the Primary Composite Endpoint at Week 14, The composite efficacy endpoint is defined as:

Subject had a reduction from baseline in total daily dose of oral calcium supplementation of at least 50%, and an albumin-adjusted total serum calcium concentration level between 8.0 mg/dL (incl.) and 10.0 mg/dL (incl.), and no increase from baseline in vitamin D metabolite/analog, 14 weeks
Secondary Outcome Measures: Albumin-adjusted serum calcium, Proportion of participants who achieved albumin-adjusted serum calcium concentrations above, below, or in the range of 8.0 mg/dl and 10.0 mg/dl during Dose Maintenance., Week 4 to Week 14|Urinary Calcium Excretion, Change From Baseline in Urinary Calcium Excretion, Week 14|Urine calcium excretion above 300mg/24h, Incidence of increase in urine calcium excretion (\>300 mg/24h) during Dose Maintenance, Week 4 to Week 14|GI symptoms, Incidence of GI symptoms associated with calcium intake, Week 4 to Week 14|Symptoms associated with hypocalcemia, Incidence of symptoms associated with hypocalcemia, Week 4 to Week 14|Hypoparathyroidism Patient Experience Scale (HPES)- Experience (HPES) - Symptom, Change from baseline in Hypoparathyroidism Patient Experience Scale (HPES) - Symptom total score at Week 14, Week 14|HPES - Impact, Change from baseline in HPES - Impact total score at Week 14, Week 14|HPES - Symptom - Physical Domain, Change from baseline HPES - Symptom - Physical Domain score at Week 14, Week 14|HPES - Symptom - Cognitive Domain, Change from baseline in HPES - Symptom - Cognitive Domain score at Week 14, Week 14|HPES - Impact - Physical Functioning Domain, Change from baseline in HPES - Impact - Physical Functioning Domain score at Week 14, eek 14|HPES - Impact - Daily Life Domain, Change from baseline in HPES - Impact - Daily Life Domain score at Week 14, Week 14|HPES - Impact - Psychological Well-Being Domain, Change from baseline in HPES - Impact - Psychological Well-Being Domain score at Week 14, Week 14|HPES - Impact - Social Life and Relationships Domain, Change from baseline in HPES - Impact - Social Life and Relationships Domain score at Week 14, Week 14|36-item Short Form (SF-36) survey, Change From baseline in health-related quality-of-life measured with 36-item Short Form (SF-36) survey at Week 14, Week 14