HypoparathyroidismPhase 2NCT06547151
Evaluating the Safety and Efficacy of AMOR-1 as a Treatment for Hypocalcemia Associated With Hypoparathyroidism in Adults
A Phase 2 study testing AMOR-1 and Crystalline Calcium Carbonate in people with Hypoparathyroidism, run by Amorphical Ltd. at 9 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoparathyroidism
- What is being tested?
- AMOR-1 and Crystalline Calcium Carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 9 sitesIsrael
- Study dates
- 15 Dec 2024to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An understanding, ability, and willingness to fully comply with study procedures and restrictions.
- Ability to voluntarily provide written, signed, and dated informed consent as applicable to participants in the study.
- Adult males or females 18 or older (prior to screening). Those < 25 years old will be examined radiologically (Bone age X-ray of non-dominant wrist and hand) to ensure epiphyseal closure prior to enrollment into the study.
- Hypoparathyroidism patients, from any etiology, who are on currently available Standard of Care (SoC) e.g., calcium supplement and active vitamin D metabolite/analog.
- Oral calcium ≥ 1000 mg QD above the normal dietary calcium intake
- Albumin-adjusted total serum calcium concentration level between 7.5 mg/dL and 10.5 mg/dL, or if outside of this range, considered not clinically significant by the Investigator.
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- Vitamin D metabolite/analog therapy with calcitriol ≥0.25μg QD or alfacalcidol ≥0.50 μg QD.
- Serum 25-hydroxyvitamin D (25OHD) ≥50 nmol/l (20 ng/ml), or if below, considered not clinically significant by the Investigator.
- No change of treatment for hypocalcemia over the last 3 months prior to Screening as reported by the patient or through medical documentation, or if a change has occurred, it is expected to remain stable, as determined by the Investigator.
- Absence or stable symptoms from hypocalcemia over the last 3 months prior to Screening as reported by the patient or through medical documentation.
- For subjects receiving thyroid replacement therapy, the dose is stable for at least 6 weeks prior to screening and the TSH serum levels are within the normal range. A serum TSH level below the lower limit of the normal range but not undetectable in participant treated with thyroid hormone may be allowed if there is no anticipated need for a change in thyroid hormone dose during the trial.
- Female subjects who are postmenopausal (12 consecutive months of spontaneous amenorrhea and age >= 51 years), or who are surgically sterilized may be enrolled, as may women of childbearing potential who had a negative pregnancy test at screening and are willing to use two medically acceptable methods of contraception for the duration of the study and undergo pregnancy testing according to the study protocol.
Who cannot join
- Any disease that might affect calcium metabolism or calcium-phosphate homeostasis other than hypoparathyroidism, such as active hyperthyroidism, Paget's disease of bone, Type 1 or poorly controlled Type 2 diabetes mellitus (HbA1c > 9%), acromegaly, multiple endocrine neoplasia types I and II, Cushing's syndrome or disease, acute pancreatitis, malnutrition, recent prolonged immobility.
- Severe liver disease (Child-Pugh score >9) (US FDA, 2003) or hepatic transaminases (ALT and AST) > 3 times the upper limit.
- Severe renal insufficiency defined as estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2.
- Clinical history of symptomatic renal stones within the past 3 months. Subjects with asymptomatic renal stones are permitted.
- Poorly controlled short bowel syndrome, bowel resection, tropical sprue, celiac disease, ulcerative colitis, and Crohn's disease.
- Chronic or severe cardiac disease within the past 6 months including but not limited to heart failure classified as NYHA Class II-IV (Dolgin and NYHA, 1994), uncontrolled arrhythmias, bradycardia (resting heart rate < 48 beats/minute), QTc >450msec (males) or >470 msec (females) on ECG.
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- History of active or untreated malignancy (excluding thyroid cancer or basal cell skin cancer) within the past 2 years. For thyroid cancers, low-risk well-differentiated thyroid cancer that is stable does not require a disease-free period. High-risk thyroid cancer or uncontrolled cases must be disease-free for at least 1 year prior to Screening.
- Seizure disorder/epilepsy with a history of a seizure within the previous 6 months prior to screening.
- Acute gout within 6 months prior to screening.
- Cerebrovascular accident within 6 months prior to Screening.
- Subjects dependent on regular parenteral calcium infusions (e.g., calcium gluconate) to maintain calcium homeostasis.
- Use of prohibited medications within respective prohibited periods prior to screening such as loop diuretics (30 days), raloxifene hydrochloride (3 months), lithium (30 days), methotrexate at dose >20 mg per week, or systemic corticosteroids (3 months).
- Thiazide diuretics may be permitted if the dosage has remained stable for three months prior to screening, and there is no expected need for a dosage change during the trial.
- Other drugs known to influence calcium and bone metabolism, such as calcitonin, cinacalcet hydrochloride, and fluoride tablets within 3 months prior to screening.
- Use of oral bisphosphonates within 6 months or IV bisphosphonate preparations within 12 months prior to screening.
- Previous treatment with PTH/parathyroid hormone-related protein-like drugs, including PTH(1-84) and PTH(1-34) within 30 days prior to screening.
- Current use of Amorphous Calcium Carbonate (ACC) food supplement.
- History of diagnosed substance abuse or alcohol dependence within the previous 3 years.
- Pregnant/ breastfeeding patients.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Israel9 sites
Assuta Ashdod medical center
Ashdod, Israel
Barzilai Medical Center
Ashkelon
Soroka Medical Center
Beersheba
Lin Medical Center
Haifa, Israel
Rambam Medical Center
Haifa
Hadassah Ein Kerem Medical Center
Jerusalem, Israel
Rabin Medical Center, Belinson Campus
Petah Tikva, Israel, 49100
Sheba Medical Center
Ramat Gan
Kaplan Medical Center
Rehovot
About this study
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.
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.
Read the 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
- Being tested
- AMOR-1, Crystalline Calcium Carbonate
- Keywords
- Amorphous Calcium Carbonate, hypoparathyroidism, Hypopara, Hypocalcemia, Calcium Carbonate
- Medical subject headings
- Hypoparathyroidism, Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMOR-1Drug
Investigational arm: Tablets containing 250mg elemental calcium from Amorphous Calcium Carbonate (ACC).
Crystalline Calcium CarbonateDrug
Control arm: Crystalline Calcium Carbonate (CCC) oral tablet contains 500 mg elemental calcium.
| Study group | Role | What they receive |
|---|---|---|
| AMOR-1 | Experimental | AMOR-1, Amorphous Calcium Carbonate (ACC) oral tablet contains 250 mg elemental calcium. Receives: Drug: AMOR-1 |
| Active Comparator | Active comparator | Crystalline Calcium Carbonate (CCC) oral tablet contains 500 mg elemental calcium. Receives: Drug: Crystalline Calcium Carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 weeks
Secondary outcomes (14)
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.
Measured: Week 4 to Week 14
Urinary Calcium Excretion
Change From Baseline in Urinary Calcium Excretion
Measured: Week 14
Urine calcium excretion above 300mg/24h
Incidence of increase in urine calcium excretion (>300 mg/24h) during Dose Maintenance
Measured: Week 4 to Week 14
GI symptoms
Incidence of GI symptoms associated with calcium intake
Measured: Week 4 to Week 14
Symptoms associated with hypocalcemia
Incidence of symptoms associated with hypocalcemia
Measured: 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
Measured: Week 14
HPES - Impact
Change from baseline in HPES - Impact total score at Week 14
Measured: Week 14
HPES - Symptom - Physical Domain
Change from baseline HPES - Symptom - Physical Domain score at Week 14
Measured: Week 14
HPES - Symptom - Cognitive Domain
Change from baseline in HPES - Symptom - Cognitive Domain score at Week 14
Measured: Week 14
HPES - Impact - Physical Functioning Domain
Change from baseline in HPES - Impact - Physical Functioning Domain score at Week 14
Measured: eek 14
HPES - Impact - Daily Life Domain
Change from baseline in HPES - Impact - Daily Life Domain score at Week 14
Measured: Week 14
HPES - Impact - Psychological Well-Being Domain
Change from baseline in HPES - Impact - Psychological Well-Being Domain score at Week 14
Measured: Week 14
HPES - Impact - Social Life and Relationships Domain
Change from baseline in HPES - Impact - Social Life and Relationships Domain score at Week 14
Measured: 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
Measured: Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start15 Dec 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amorphical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ilan Shimon, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547151
- Sponsor's protocol ID
- AMCS-HP-011
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06547151
- Acronym / sponsor ID
- AMCS-HP-011
- Conditions
- Hypoparathyroidism
- Keywords
- Amorphous Calcium Carbonate, hypoparathyroidism, Hypopara, Hypocalcemia, Calcium Carbonate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Amorphical Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMOR-1 | Experimental | Drug: AMOR-1AMOR-1, Amorphous Calcium Carbonate (ACC) oral tablet contains 250 mg elemental calcium. |
| Active Comparator | Active comparator | Drug: Crystalline Calcium CarbonateCrystalline Calcium Carbonate (CCC) oral tablet contains 500 mg elemental calcium. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- An understanding, ability, and willingness to fully comply with study procedures and restrictions.
- Ability to voluntarily provide written, signed, and dated informed consent as applicable to participants in the study.
- Adult males or females 18 or older (prior to screening). Those < 25 years old will be examined radiologically (Bone age X-ray of non-dominant wrist and hand) to ensure epiphyseal closure prior to enrollment into the study.
- Hypoparathyroidism patients, from any etiology, who are on currently available Standard of Care (SoC) e.g., calcium supplement and active vitamin D metabolite/analog.
- Oral calcium ≥ 1000 mg QD above the normal dietary calcium intake
Key exclusion criteria (19 listed)
- Any disease that might affect calcium metabolism or calcium-phosphate homeostasis other than hypoparathyroidism, such as active hyperthyroidism, Paget's disease of bone, Type 1 or poorly controlled Type 2 diabetes mellitus (HbA1c > 9%), acromegaly, multiple endocrine neoplasia types I and II, Cushing's syndrome or disease, acute pancreatitis, malnutrition, recent prolonged immobility.
- Severe liver disease (Child-Pugh score >9) (US FDA, 2003) or hepatic transaminases (ALT and AST) > 3 times the upper limit.
- Severe renal insufficiency defined as estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2.
- Clinical history of symptomatic renal stones within the past 3 months. Subjects with asymptomatic renal stones are permitted.
- Poorly controlled short bowel syndrome, bowel resection, tropical sprue, celiac disease, ulcerative colitis, and Crohn's disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMOR-1Investigational arm: Tablets containing 250mg elemental calcium from Amorphous Calcium Carbonate (ACC). | Drug | AMOR-1 |
| Crystalline Calcium CarbonateControl arm: Crystalline Calcium Carbonate (CCC) oral tablet contains 500 mg elemental calcium. | Drug | Active Comparator |
Primary outcome
Percentage of Subjects Who Achieved the Primary Composite Endpoint at Week 14
Time frame: 14 weeks
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 secondary outcomes
Albumin-adjusted serum calcium
Time frame: Week 4 to Week 14
Urinary Calcium Excretion
Time frame: Week 14
Urine calcium excretion above 300mg/24h
Time frame: Week 4 to Week 14
GI symptoms
Time frame: Week 4 to Week 14
Symptoms associated with hypocalcemia
Time frame: Week 4 to Week 14
Hypoparathyroidism Patient Experience Scale (HPES)- Experience (HPES) - Symptom
Time frame: Week 14
HPES - Impact
Time frame: Week 14
HPES - Symptom - Physical Domain
Time frame: Week 14
HPES - Symptom - Cognitive Domain
Time frame: Week 14
HPES - Impact - Physical Functioning Domain
Time frame: eek 14
HPES - Impact - Daily Life Domain
Time frame: Week 14
HPES - Impact - Psychological Well-Being Domain
Time frame: Week 14
HPES - Impact - Social Life and Relationships Domain
Time frame: Week 14
36-item Short Form (SF-36) survey
Time frame: Week 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilan Shimon, MD principal investigator
Principal Investigator
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMOR-1 and Crystalline Calcium Carbonate in people with Hypoparathyroidism, run by Amorphical Ltd. at 9 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects Who Achieved the Primary Composite Endpoint at Week 14 (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.