Actively Recruiting
Evaluating the Safety and Efficacy of AMOR-1 as a Treatment for Hypocalcemia Associated With Hypoparathyroidism in Adults
Led by Amorphical Ltd. · Updated on 2025-09-04
81
Participants Needed
8
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- 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.
- 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.
You will not qualify if you...
- 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.
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here