HypoparathyroidismPhase 3NCT07706764
A Study to Test the Effects and Safety of Palopegteriparatide in Adolescents With Long-term Hypoparathyroidism
A Phase 3 study testing Palopegteriparatide in people with Hypoparathyroidism, run by Ascendis Pharma A/S at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Hypoparathyroidism
- What is being tested?
- Palopegteriparatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 22 Apr 2026to Aug 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
France2 sites, 2 recruiting
- Recruiting
Ascendis Pharma Investigational Site
Bron, 69500
- Recruiting
Ascendis Pharma Investigational Site
Le Kremlin-Bicêtre, 94270
Poland1 site, 1 recruiting
- Recruiting
Ascendis Pharma Investigational Site
Lodz, 93-338
About this study
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
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.
- Conditions
- Hypoparathyroidism
- Being tested
- Palopegteriparatide
- Medical subject headings
- Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalopegteriparatideCombination product
Also called Yorvipath
Subcutaneous injection for 234 weeks
| Study group | Role | What they receive |
|---|---|---|
| Palopegteriparatide, once daily | Experimental | Participants will receive palopegteriparatide by subcutaneous injection for 234 weeks Receives: Combination Product: Palopegteriparatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 26 weeks
Secondary outcomes (13)
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.
Measured: 234 weeks
Serum biochemistries
Change from baseline and normalization of serum calcium, mmol/L
Measured: 234 weeks
Serum biochemistries
Change from baseline and normalization of serum phosphate, mmol/L
Measured: 234 weeks
Serum biochemistries
Change from baseline and normalization of serum creatinine, mL/min
Measured: 234 weeks
Renal calcifications
Incidence of nephrolithiasis or nephrocalcinosis on renal ultrasound
Measured: 234 weeks
Hospitalizations/emergency room (ER)/urgent care visits
Number of hospitalizations/ER/urgent care visits
Measured: 234 weeks
Adverse events
Percentage of participants experiencing an adverse event
Measured: 234 weeks
Bone mineral density
Bone mineral density measured by dual-energy x-ray absorptiometry (DXA)
Measured: 234 weeks
Bone turnover marker
Qualitative evaluation of bone turnover marker ctx (ng/L) in blood sample
Measured: 234 weeks
Bone turnover marker
Qualitative evaluation of bone turnover marker p1np (ng/mL) in blood sample
Measured: 234 weeks
HPES-Symptom score
Hypoparathyroidism Patient Experience Scale (HPES) Symptom score, including Physical and Cognitive Domains
Measured: 234 weeks
HPES-Impact score
Hypoparathyroidism Patient Experience Scale (HPES) Impact score, including Physical Functioning and Daily Life Domains
Measured: 234 weeks
Urine biochemistries
Urine biochemistries to include 24-hour urine calcium
Measured: 234 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start22 Apr 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label single arm multi center
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascendis Pharma A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Ascendis Pharma A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706764
- Sponsor's protocol ID
- ASND0035
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07706764
- Acronym / sponsor ID
- ASND0035
- Conditions
- Hypoparathyroidism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Ascendis Pharma A/SIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label single arm multi center
| Arm | Type | Receives |
|---|---|---|
| Palopegteriparatide, once daily | Experimental | Combination Product: PalopegteriparatideParticipants will receive palopegteriparatide by subcutaneous injection for 234 weeks |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PalopegteriparatideAlso: YorvipathSubcutaneous injection for 234 weeks | Combination product | Palopegteriparatide, once daily |
Primary outcome
Percentage of participants meeting the multicomponent efficacy endpoint at Week 26
Time frame: 26 weeks
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
13 secondary outcomes
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
Urine biochemistries
Time frame: 234 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director, MD study director
Ascendis Pharma A/S
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Palopegteriparatide in people with Hypoparathyroidism, run by Ascendis Pharma A/S at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ascendis Registry Inquiries (+45 61242484, asnd_registryinquiries@ascendispharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants meeting the multicomponent efficacy endpoint at Week 26 (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.