Evaluating the Safety and Efficacy of AMOR-1 as a Treatment for Hypocalcemia Associated With Hypoparathyroidism in Adults

NCT06547151 | Recruiting Phase 2 FDA Drug

• 1 other identifier: AMCS-HP-011
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Hypoparathyroidism

Keywords

Amorphous Calcium Carbonate; hypoparathyroidism; Hypopara; Hypocalcemia; Calcium Carbonate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Albumin-adjusted serum calcium

  Week 4 to Week 14

• Urinary Calcium Excretion

  Week 14

• Urine calcium excretion above 300mg/24h

  Week 4 to Week 14

• GI symptoms

  Week 4 to Week 14

• Symptoms associated with hypocalcemia

  Week 4 to Week 14

Study Arms (2)

AMOR-1

EXPERIMENTAL

AMOR-1, Amorphous Calcium Carbonate (ACC) oral tablet contains 250 mg elemental calcium.

Drug: AMOR-1

Active Comparator

ACTIVE COMPARATOR

Crystalline Calcium Carbonate (CCC) oral tablet contains 500 mg elemental calcium.

Drug: Crystalline Calcium Carbonate

Interventions

AMOR-1 DRUG

Investigational arm: Tablets containing 250mg elemental calcium from Amorphous Calcium Carbonate (ACC).

AMOR-1

Crystalline Calcium Carbonate DRUG

Control arm: Crystalline Calcium Carbonate (CCC) oral tablet contains 500 mg elemental calcium.

Active Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Amorphical Ltd.: lead

Study Sites (8)

Assuta Ashdod medical center

Ashdod, Israel, Israel

RECRUITING

Hadassah Ein Kerem Medical Center

Jerusalem, Israel, Israel

RECRUITING

Rabin Medical Center, Belinson Campus

Petah Tikva, Israel, 49100, Israel

RECRUITING

Barzilai Medical Center

Ashkelon, Israel

ACTIVE NOT RECRUITING

Soroka Medical Center

Beersheba, Israel

RECRUITING

Rambam Medical Center

Haifa, Israel

NOT YET RECRUITING

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

Kaplan Medical Center

Rehovot, Israel

NOT YET RECRUITING

MeSH Terms

Conditions

Hypoparathyroidism; Hypocalcemia

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Study Officials

• Ilan Shimon, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator - Rabin Medical Center

CONTACT

972-3-9377182; liatro3@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 9, 2024
• Study Start: December 15, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (8)