NCT07706764

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_3

Timeline
61mo left

Started Apr 2026

Longer than P75 for phase_3

Geographic Reach
2 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Aug 2031

Study Start

First participant enrolled

April 22, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2031

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

1.3 years

First QC Date

June 23, 2026

Last Update Submit

July 27, 2026

Conditions

Hypoparathyroidism

Outcome Measures

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

    26 weeks

Secondary Outcomes (13)

  • Percentage of participants meeting the multicomponent efficacy endpoint through Week 234

    234 weeks

  • Serum biochemistries

    234 weeks

  • Serum biochemistries

    234 weeks

  • Serum biochemistries

    234 weeks

  • Renal calcifications

    234 weeks

  • +8 more secondary outcomes

Study Arms (1)

Palopegteriparatide, once daily

EXPERIMENTAL

Participants will receive palopegteriparatide by subcutaneous injection for 234 weeks

Combination Product: Palopegteriparatide

Interventions

PalopegteriparatideCOMBINATION_PRODUCT

Subcutaneous injection for 234 weeks

Also known as: Yorvipath
Palopegteriparatide, once daily

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \. Males and females, 12 to less than 18 years of age
  • \. Participants with postsurgical chronic hypoparathyroidism, or auto-immune, genetic, or idiopathic hypoparathyroidism for at least 26 weeks
  • \. Normal levels of serum 25(OH) vitamin D and magnesium
  • \. Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73
  • \. Able to perform daily subcutaneous self-injections of palopegteriparatide (or have a caregiver to perform injections)
  • \. Body mass index (BMI) Z-score greater than -2 SDS and below + 3 SDS
  • \. Written, signed informed consent

You may not qualify if:

  • \. Impaired responsiveness to PTH which is characterized as PTH-resistance, with elevated PTH levels in the setting of hypocalcemia
  • \. Any disease that might affect calcium metabolism or calcium-phosphate homeostasis or PTH levels other than hypoparathyroidism, such as active hyperthyroidism
  • \. 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
  • \. Use of thiazide diuretic
  • \. Use of PTH-like drugs
  • \. 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
  • \. 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
  • \. Non-hypocalcemic seizure disorder with occurrence of a seizure within 26 weeks prior to Screening
  • \. Increased risk for osteosarcoma
  • \. Female participants who are pregnant, intend to become pregnant, or are lactating
  • \. Diagnosed drug or alcohol dependence within 3 years prior to Screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

MeSH Terms

Conditions

Hypoparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System Diseases

Study Officials

  • Medical Director, MD

    Ascendis Pharma A/S

    STUDY DIRECTOR

Central Study Contacts

Ascendis Registry Inquiries

CONTACT

+45 61242484asnd_registryinquiries@ascendispharma.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open-label single arm multi center
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2026

First Posted

July 16, 2026

Study Start

April 22, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2031

Last Updated

July 28, 2026

Record last verified: 2026-07

Locations

FR(2)PL(1)