Palopegteriparatide in adolescents with long-term hypoparathyroidism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 interventional trial enrolling adolescents aged 12 to under 18 with chronic hypoparathyroidism. Participants will receive palopegteriparatide once daily to assess safety and how well it manages their condition over about 234 weeks. The study focuses on those with postsurgical, autoimmune, genetic, or idiopathic forms of the disease and requires adequate vitamin D and magnesium, kidney function, and the ability to self‑inject or have a caregiver administer injections. Key outcomes include safety profiles and biochemical control of calcium and related parameters. The trial is conducted across Ascendis Pharma investigational sites in Europe.

Why it matters

Who can join: the full rules

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

Where it's running

• Ascendis Pharma Investigational Site
  Bron, France Recruiting
• Ascendis Pharma Investigational Site
  Le Kremlin-Bicêtre, France Recruiting
• Ascendis Pharma Investigational Site
  Lodz, Poland Recruiting

Study contacts

• Study coordinator: Ascendis Registry Inquiries
• Email: asnd_registryinquiries@ascendispharma.com
• Phone: +45 61242484

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• German Hypoparathyroidism Registry

  This registry in Germany collects information from adults with chronic hypoparathyroidism or pseudohypoparathyroidism to better understand how the condition affects people over time and to support future research.

  Recruiting University Hospital Augsburg · Augsburg, Bavaria · NCT07857460

• Encaleret for Chronic Hypoparathyroidism: Testing if it helps symptoms and safety

  This study tests whether taking encaleret pills can help people with chronic hypoparathyroidism, while being safe and tolerable.

  Recruiting at 5 sites Phase 3 Calcilytix Therapeutics, Inc., a BridgeBio company · Reno, Nevada and 4 other locations · NCT07805356

• Canvuparatide vs placebo in adults with hypoparathyroidism

  This study tests whether weekly canvuparatide can help adults with hypoparathyroidism feel better and keep calcium levels steady compared with a placebo.

  Recruiting at 22 sites Phase 3 MBX Biosciences · Englewood, Colorado and 21 other locations · NCT07699471

• NIRAF-guided identification of parathyroids during thyroidectomy

  A wearable near-infrared autofluorescence device is being tested to help surgeons find and protect the parathyroid glands during thyroid surgery in adults.

  Recruiting Ss. Cyril and Methodius University of Skopje · Skopje · NCT07617584

• Pregnancy registry tracking outcomes after YORVIPATH exposure during pregnancy and breastfeeding

  This registry collects information from pregnant or breastfeeding people with hypoparathyroidism who took YORVIPATH to see if the exposure affects pregnancy, the baby, or infant outcomes through the first year of life.

  Recruiting Ascendis Pharma A/S · Morgantown, West Virginia · NCT07345494

• Palopegteriparatide levels in breast milk of lactating individuals taking YORVIPATH.

  This will see if palopegteriparatide (YORVIPATH) appears in the breast milk of lactating adults with hypoparathyroidism who are breastfeeding.

  Recruiting Ascendis Pharma A/S · Morgantown, West Virginia · NCT07264634

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.