ClinicalTrials.gg
RecruitingNCT07706764Updated Jul 28, 2026

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

A Phase 3 interventional study of Palopegteriparatide in Hypoparathyroidism, sponsored by Ascendis Pharma A/S. Recruiting at 3 sites in 2 countries. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by Ascendis Pharma A/S · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
12 Years to 18 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hypoparathyroidism

Browse trials for

03

In context

Hypoparathyroidism

128 studies on the registry are indexed under Hypoparathyroidism; 30 are open to participants now.

This study's planned enrollment of 12 is below the median of 50 across 77 interventional studies indexed under Hypoparathyroidism.

Browse Hypoparathyroidism studies →

Lead sponsor

Ascendis Pharma A/S is the lead sponsor of 17 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (eGFR) ≥30 mL/min/1.73
  • 5. Able to perform daily subcutaneous self-injections of palopegteriparatide (or have a caregiver to perform injections)
  • 6. (BMI) Z-score greater than -2 SDS and below + 3 SDS
  • 7. Written, signed

Exclusion criteria

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 (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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Palopegteriparatide, once daily

    Participants will receive palopegteriparatide by subcutaneous injection for 234 weeks

    Combination Product: Palopegteriparatide

Interventions

  • Combination productPalopegteriparatide

    Subcutaneous injection for 234 weeks

    Also known as: Yorvipath

06

What researchers measure

Primary outcomes

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

    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

    Time frame: 26 weeks

Secondary outcomes

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

    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.

    Time frame: 234 weeks

  2. Serum biochemistries

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

    Time frame: 234 weeks

  3. Serum biochemistries

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

    Time frame: 234 weeks

  4. Serum biochemistries

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

    Time frame: 234 weeks

  5. Renal calcifications

    Incidence of nephrolithiasis or nephrocalcinosis on renal ultrasound

    Time frame: 234 weeks

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

    Number of hospitalizations/ER/urgent care visits

    Time frame: 234 weeks

  7. Adverse events

    Percentage of participants experiencing an adverse event

    Time frame: 234 weeks

  8. Bone mineral density

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

    Time frame: 234 weeks

  9. Bone turnover marker

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

    Time frame: 234 weeks

  10. Bone turnover marker

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

    Time frame: 234 weeks

  11. HPES-Symptom score

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

    Time frame: 234 weeks

  12. HPES-Impact score

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

    Time frame: 234 weeks

  13. Urine biochemistries

    Urine biochemistries to include 24-hour urine calcium

    Time frame: 234 weeks

07

Study locations

3 of 3 sites recruiting
  • Ascendis Pharma Investigational Site
    Bron, 69500, France
    Recruiting
  • Ascendis Pharma Investigational Site
    Le Kremlin-Bicêtre, 94270, France
    Recruiting
  • Ascendis Pharma Investigational Site
    Lodz, 93-338, Poland
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07706764
Lead sponsor
Ascendis Pharma A/S
Responsible party
Sponsor
First posted
Jul 16, 2026
Start date
Apr 22, 2026
Primary completion
Aug 2027 (estimated)
Completion
Aug 2031 (estimated)
Last update
Jul 28, 2026

Study contacts

Ascendis Registry Inquiries
Contact
asnd_registryinquiries@ascendispharma.com
+45 61242484
Medical Director, MD
study director · Ascendis Pharma A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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