Could a daily shot free teens from calcium pills?
NCT ID NCT07706764
First seen Jul 16, 2026 · Last updated Jul 29, 2026 · Updated 3 times
Summary
This study tests a daily injection called palopegteriparatide (Yorvipath) in adolescents aged 12 to 18 with chronic hypoparathyroidism, a condition where the body cannot regulate calcium levels. The goal is to see if the drug can safely bring calcium into the normal range while allowing participants to stop taking active vitamin D and high-dose calcium supplements. The trial follows participants for 234 weeks and is being conducted in Europe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a daily injection of palopegteriparatide (also known as Yorvipath)
- What this could lead to
- If successful, this could offer adolescents with chronic hypoparathyroidism a way to control calcium levels without needing daily vitamin D or high-dose calcium supplements.
- What could go wrong
- This is a small, single-arm study with no placebo group, so results may not be definitive. Long-term safety and effectiveness beyond 234 weeks are not yet known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ascendis Pharma Investigational Site
RECRUITINGBron, 69500, France
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Ascendis Pharma Investigational Site
RECRUITINGLe Kremlin-Bicêtre, 94270, France
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Ascendis Pharma Investigational Site
RECRUITINGLodz, 93-338, Poland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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