Actively Recruiting
A Phase 2, Multinational, Double-Blind, Randomized Study Evaluating AMOR-1 for Treatment of Hypocalcemia in Adults with Hypoparathyroidism
Led by Amorphical Ltd. · Updated on 2025-09-04
81
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying AMOR-1, a treatment containing Amorphous Calcium Carbonate (ACC), to evaluate its safety and effectiveness in managing low blood calcium levels (hypocalcemia) in adults with hypoparathyroidism. The study focuses on whether AMOR-1, which provides higher calcium absorption at lower doses, can maintain calcium levels while potentially reducing side effects from high calcium intake. This is a Phase 2, double-blind, randomized trial comparing AMOR-1 with a conventional calcium supplement in adults with this condition. Participants will be randomly assigned in a 2:1 ratio to receive either AMOR-1 tablets containing 250 mg elemental calcium or a control tablet with 500 mg elemental calcium. Their usual calcium supplement will be gradually replaced with the assigned treatment over 2 to 4 weeks. After this replacement phase, the AMOR-1 group will receive half the elemental calcium dose compared to their initial intake, while the control group maintains their usual dose. Both groups continue treatment for 10 to 12 weeks before returning to their original supplement for one month of monitoring. All participants will also take an active form of vitamin D throughout the study. During the study, participants will undergo regular safety and effectiveness checks, including blood and urine calcium testing and symptom assessments related to hypocalcemia. Researchers will measure outcomes such as the percentage of participants achieving the main treatment goal by week 14, calcium levels, urinary calcium excretion, gastrointestinal symptoms, and quality of life surveys. The total participation includes the replacement, dose maintenance, and follow-up phases, lasting approximately 14 weeks plus one month of observation after returning to the original supplement.
CONDITIONS
Brief Title
Evaluating the Safety and Efficacy of AMOR-1 as a Treatment for Hypocalcemia Associated With Hypoparathyroidism in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability and willingness to comply with study procedures and restrictions
- Ability to provide written informed consent
- Adults aged 18 years or older
- Diagnosed with hypoparathyroidism and currently on standard calcium and active vitamin D therapy
- Taking at least 1000 mg oral calcium daily above normal diet
- Serum calcium levels between 7.5 and 10.5 mg/dL or considered stable
- Receiving vitamin D therapy with calcitriol ≥0.25 µg daily or alfacalcidol ≥0.50 µg daily
- Stable treatment and symptoms of hypocalcemia for at least 3 months prior to screening
- Stable thyroid treatment if applicable and normal TSH levels
- Women postmenopausal, surgically sterilized, or using effective contraception with negative pregnancy test
You will not qualify if you...
- Diseases affecting calcium metabolism other than hypoparathyroidism, including active hyperthyroidism, Paget's disease, uncontrolled diabetes, acromegaly, MEN types I and II, Cushing's syndrome, acute pancreatitis, malnutrition, recent immobility
- Severe liver disease or elevated liver enzymes
- Severe kidney failure (eGFR < 30 ml/min/1.73 m2)
- Recent symptomatic kidney stones within 3 months
- Poorly controlled gastrointestinal diseases like short bowel syndrome, celiac disease, inflammatory bowel disease
- Recent severe cardiac conditions including heart failure, uncontrolled arrhythmias, bradycardia, or abnormal ECG
- Active or untreated cancer within 2 years except stable low-risk thyroid or skin cancer
- Recent seizures, acute gout, or stroke within 6 months
- Dependence on regular intravenous calcium infusions
- Use of certain prohibited medications prior to screening
- Current use of Amorphous Calcium Carbonate supplements
- History of substance abuse or alcohol dependence in past 3 years
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 4 weeks
Participants' current calcium supplement dose is gradually replaced with either AMOR-1 or the Control supplement.
Weekly visits for up to 4 weeks
Duration - 10 to 12 weeks
Participants continue receiving their assigned dose of AMOR-1 or Control supplement while being monitored for safety and efficacy.
Weekly visits for 10 to 12 weeks
Duration - 4 weeks
Participants revert to their initial calcium supplement and are monitored for safety and efficacy until the end of the study.
Approximately 4 follow-up visits
Trial Site Locations
Total: 8 locations
1
Assuta Ashdod medical center
Ashdod, Israel, Israel
Actively Recruiting
2
Hadassah Ein Kerem Medical Center
Jerusalem, Israel, Israel
Actively Recruiting
3
Rabin Medical Center, Belinson Campus
Petah Tikva, Israel, Israel, 49100
Actively Recruiting
4
Barzilai Medical Center
Ashkelon, Israel
Active, Not Recruiting
5
Soroka Medical Center
Beersheba, Israel
Actively Recruiting
6
Rambam Medical Center
Haifa, Israel
Not Yet Recruiting
7
Sheba Medical Center
Ramat Gan, Israel
Actively Recruiting
8
Kaplan Medical Center
Rehovot, Israel
Not Yet Recruiting
Research Team
S
Study Coordinator - Rabin Medical Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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