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Tests treatment safety and results for Hypoparathyroidism
Official title A Study to Test the Effects and Safety of Palopegteriparatide in Adolescents With Long-term Hypoparathyroidism
ClinicalTrials.gov ID: NCT07706764
What this study is testing
What is Palopegteriparatide?
Palopegteriparatide is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for hypoparathyroidism.
Also referred to as Yorvipath.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 18
You may be able to join if
- 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)
You likely can't join if
- 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...
- 3\. Use of loop diuretics, phosphate binders (other than calcium supplements), digoxin, lithium, methotrexate, biotin \>30 µg/day, or systemic...
- 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...
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lodz, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lodz, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.