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A Study to Test the Effects and Safety of Palopegteriparatide in Adolescents With Long-term Hypoparathyroidism

RecruitingPhase 3

Sponsor: Ascendis Pharma A/S

Conditions: Hypoparathyroidism

Interventions: Palopegteriparatide

Countries: France, Poland

This trial will enroll adolescents between ages of ≥12 and \<18 years with clinically diagnosed hypoparathyroidism . The purpose of the study is to see how well treatment with once-daily palopegteriparatide works and how safe it is. At least 12 participants will receive palopegteriparatide for 234 weeks. This trial will be conducted in Europe.

Eligibility overview

Sex: ALL

Age: 12 Years to 18 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 1\. Males and females, 12 to less than 18 years of age
* 2\. Participants with postsurgical chronic hypoparathyroidism, or auto-immune, genetic, or idiopathic hypoparathyroidism for at least 26 weeks
* 3\. Normal levels of serum 25(OH) vitamin D and magnesium
* 4\. Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73
* 5\. Able to perform daily subcutaneous self-injections of palopegteriparatide (or have a caregiver to perform injections)
* 6\. Body mass index (BMI) Z-score greater than -2 SDS and below + 3 SDS
* 7\. Written, signed informed consent

Exclusion Criteria:

* 1\. Impaired responsiveness to PTH which is characterized as PTH-resistance, with elevated PTH levels in the setting of hypocalcemia
* 2\. Any disease that might affect calcium metabolism or calcium-phosphate homeostasis or PTH levels other than hypoparathyroidism, such as active hyperthyroidism
* 3\. Use of loop diuretics, phosphate binders (other than calcium supplements), digoxin, lithium, methotrexate, biotin \>30 µg/day, or systemic corticosteroids (other than as replacement therapy). Short course use of steroids (≤2 weeks/year) equivalent to prednisone ≤60 mg/day is permitted
* 4\. Use of thiazide diuretic
* 5\. Use of PTH-like drugs
* 6\. Use of other drugs known to influence calcium and bone metabolism, such as calcitonin, fluoride tablets (\>0.5 mg/day), strontium, or cinacalcet hydrochloride, within 12 weeks prior to Screening
* 7\. Use of osteoporosis therapies known to influence calcium and bone metabolism, i.e., bisphosphonate (oral or intravenous \[IV\]), denosumab, raloxifene, or romosozumab therapies within 2 years prior to Screening
* 8\. Non-hypocalcemic seizure disorder with occurrence of a seizure within 26 weeks prior to Screening
* 9\. Increased risk for osteosarcoma
* 10\. Female participants who are pregnant, intend to become pregnant, or are lactating
* 11\. Diagnosed drug or alcohol dependence within 3 years prior to Screening

Locations (3)

Bron, France
Le Kremlin-Bicêtre, France
Lodz, Poland