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Recruiting NCT07706764

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

Phase III Interventional Hypoparathyroidism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Palopegteriparatide.
Who it may be relevant to
Registry conditions: Hypoparathyroidism. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France, Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Multicenter, Open-Label Single-Arm Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Palopegteriparatide Administered Subcutaneously Daily in the Adolescent Population (12 Years to Less Than 18 Years of Age) With Chronic Hypoparathyroidism

Overview

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

  • Combination product Palopegteriparatide
    Subcutaneous injection for 234 weeks

Primary outcome measures

  • Percentage of participants meeting the multicomponent efficacy endpoint at Week 26 [Time frame: 26 weeks]
Secondary outcome measures (12)
  • Percentage of participants meeting the multicomponent efficacy endpoint through Week 234 [Time frame: 234 weeks]
  • Serum biochemistries [Time frame: 234 weeks]
  • Serum biochemistries [Time frame: 234 weeks]
  • Serum biochemistries [Time frame: 234 weeks]
  • Renal calcifications [Time frame: 234 weeks]
  • Hospitalizations/emergency room (ER)/urgent care visits [Time frame: 234 weeks]
  • Adverse events [Time frame: 234 weeks]
  • Bone mineral density [Time frame: 234 weeks]
  • Bone turnover marker [Time frame: 234 weeks]
  • Bone turnover marker [Time frame: 234 weeks]
  • HPES-Symptom score [Time frame: 234 weeks]
  • HPES-Impact score [Time frame: 234 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 2 centers
  • Ascendis Pharma Investigational Site — Bron
  • Ascendis Pharma Investigational Site — Le Kremlin-Bicêtre
Poland · 1 center
  • Ascendis Pharma Investigational Site — Lodz

Identifiers

NCT: NCT07706764 · ASND0035

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗