Skip to content

Trial · Interventional

RecruitingPhase 3Registry data

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

NCTNCT07706764 (opens ClinicalTrials.gov in a new tab)Other idASND0035
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 3
Enrollment
12 participants (estimated)
Sponsor
Ascendis Pharma A/S · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
2 countries

France, Poland

Start
22 Apr 2026
Primary completion
Aug 2027 (estimated)
Completion
Aug 2031 (estimated)
First posted
16 Jul 2026
Last update posted
28 Jul 2026
Conditions
Hypoparathyroidism

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2026202720282029203020312032
  1. Ph 3

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

    NCT07706764

    22 Apr 2026 to est. Aug 2031

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • PalopegteriparatideCombination product

Arms1

  • Experimental

    Palopegteriparatide, once daily

    Participants will receive palopegteriparatide by subcutaneous injection for 234 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of participants meeting the multicomponent efficacy endpoint at Week 26

    Time frame · 26 weeks

    Registry description

    The multi-component endpoint is the percentage of participants who met the following criteria at Week 26: 1) albumin-adjusted serum calcium within the normal range ; 2) independence from active vitamin D, and 3) independence from therapeutic doses of calcium

Secondary outcomes(13)

  1. Percentage of participants meeting the multicomponent efficacy endpoint through Week 234

    Time frame · 234 weeks

    Registry description

    The multi-component endpoint is the percentage of participants who met the following criteria: 1) albumin-adjusted serum calcium within the normal range (8.3-10.6 mg/dL) 2) independence from active vitamin D; and 3) independence from therapeutic doses of calcium.

  2. Serum biochemistries

    Time frame · 234 weeks

    Registry description

    Change from baseline and normalization of serum calcium, mmol/L

  3. Serum biochemistries

    Time frame · 234 weeks

    Registry description

    Change from baseline and normalization of serum phosphate, mmol/L

  4. Serum biochemistries

    Time frame · 234 weeks

    Registry description

    Change from baseline and normalization of serum creatinine, mL/min

  5. Renal calcifications

    Time frame · 234 weeks

    Registry description

    Incidence of nephrolithiasis or nephrocalcinosis on renal ultrasound

  6. Hospitalizations/emergency room (ER)/urgent care visits

    Time frame · 234 weeks

    Registry description

    Number of hospitalizations/ER/urgent care visits

  7. Adverse events

    Time frame · 234 weeks

    Registry description

    Percentage of participants experiencing an adverse event

  8. Bone mineral density

    Time frame · 234 weeks

    Registry description

    Bone mineral density measured by dual-energy x-ray absorptiometry (DXA)

  9. Bone turnover marker

    Time frame · 234 weeks

    Registry description

    Qualitative evaluation of bone turnover marker ctx (ng/L) in blood sample

  10. Bone turnover marker

    Time frame · 234 weeks

    Registry description

    Qualitative evaluation of bone turnover marker p1np (ng/mL) in blood sample

  11. HPES-Symptom score

    Time frame · 234 weeks

    Registry description

    Hypoparathyroidism Patient Experience Scale (HPES) Symptom score, including Physical and Cognitive Domains

  12. HPES-Impact score

    Time frame · 234 weeks

    Registry description

    Hypoparathyroidism Patient Experience Scale (HPES) Impact score, including Physical Functioning and Daily Life Domains

  13. Urine biochemistries

    Time frame · 234 weeks

    Registry description

    Urine biochemistries to include 24-hour urine calcium

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 12 Years up to 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.