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

Launched by AMORPHICAL LTD. · Aug 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AMOR-1 for adults with hypoparathyroidism, a condition where the body doesn’t produce enough parathyroid hormone, leading to low calcium levels (hypocalcemia). The trial aims to see if AMOR-1, which contains a type of calcium called Amorphous Calcium Carbonate, is safe and effective in raising calcium levels in these patients. The trial is currently recruiting participants aged 18 and older who are already on standard treatments for hypocalcemia, including calcium supplements and vitamin D.

To be eligible for the trial, participants need to fully understand the study and agree to follow its procedures. They should also have certain calcium levels and be stable on their current treatment for at least three months. Participants can expect to undergo regular assessments and be monitored closely during the trial to ensure their safety. It’s important to note that certain medical conditions and medications may exclude individuals from joining, so interested patients should discuss their eligibility with their healthcare provider.

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Eligibility criteria

• Inclusion Criteria:
• • 1. An understanding, ability, and willingness to fully comply with study procedures and restrictions.
• • 2. Ability to voluntarily provide written, signed, and dated informed consent as applicable to participants in the study.
• • 3. Adult males or females 18 or older (prior to screening). Those \< 25 years old will be examined radiologically to ensure epiphyseal closure prior to enrollment into the study.
• • 4. Hypoparathyroidism patients, from any etiology, who are on currently available Standard of Care (SoC) e.g., calcium supplement and active vitamin D metabolite/analog.
• • 5. Oral calcium ≥ 1000 mg QD above the normal dietary calcium intake
• • 6. 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.
• • 7. Vitamin D metabolite/analog therapy with calcitriol ≥0.25μg QD or alfacalcidol ≥0.50 μg QD.
• • 8. Serum 25-hydroxyvitamin D (25OHD) ≥50 nmol/l (20 ng/ml), or if below, considered not clinically significant by the Investigator.
• • 9. No change of treatment for hypocalcemia over the last 3 months prior to Screening as reported by the patient or through medical documentation.
• • 10. Absence of symptoms from hypocalcemia over the last 3 months prior to Screening as reported by the patient or through medical documentation.
• • 11. 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.
• • 12. 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.
• Exclusion Criteria:
• • 1. Any disease that might affect calcium metabolism or calcium- 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, severe and chronic cardiac, liver or renal disease, , acute pancreatitis, malnutrition, recent prolonged immobility, active malignancy, myeloma.
• • 2. Hepatic transaminases (ALT and AST) \> 3 times the upper limit.
• • 3. Severe renal insufficiency defined as estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m2.
• • 4. Clinical history of symptomatic renal stones within the past 3 months. Subjects with asymptomatic renal stones are permitted.
• • 5. Poorly controlled short bowel syndrome, bowel resection, tropical sprue, celiac disease, ulcerative colitis, and Crohn's disease.
• • 6. Chronic/severe cardiac disease including but not limited to cardiac failure, arrhythmias, bradycardia (resting heart rate \< 48 beats/minute).
• • 7. Seizure disorder/epilepsy with a history of a seizure within the previous 6 months prior to screening.
• • 8. Acute gout within 6 months prior to screening.
• • 9. Cerebrovascular accident within 2 years prior to Screening.
• • 10. Subjects dependent on regular parenteral calcium infusions (e.g., calcium gluconate) to maintain calcium homeostasis.
• • 11. 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 (3 months), or systemic corticosteroids (3 months).
• • 12. 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.
• • 13. Other drugs known to influence calcium and bone metabolism, such as calcitonin, cinacalcet hydrochloride, and fluoride tablets within 3 months prior to screening.
• • 14. Use of oral bisphosphonates within 6 months or IV bisphosphonate preparations within 12 months prior to screening.
• • 15. Previous treatment with PTH/parathyroid hormone-related protein-like drugs, including PTH(1-84) and PTH(1-34) within 30 days prior to screening.
• • 16. History of diagnosed substance abuse or alcohol dependence within the previous 3 years.
• • 17. Pregnant/ breastfeeding patients.