HypoparathyroidismPhase 3PaTHway60NCT07081997
A Phase 3 Randomized Clinical Trial to Investigate the Safety and Efficacy of Palopegteriparatide at Doses Greater Than 30 μg/Day in Adult Participants With Hypoparathyroidism
A Phase 3 study testing Palopegteriparatide Experimental Arm in people with Hypoparathyroidism and Endocrine System Diseases, run by Ascendis Pharma Bone Diseases A/S at 9 sites in United States.
Trial summary
This trial has a treatment duration of 78 weeks and will include adult participants already on treatment with palopegteriparatide at doses at or greater than 30 mcg/day. All participants will receive subcutaneous palopegteriparatide during the trial and will be individually and progressively titrated to an optimal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoparathyroidism, Endocrine System Diseases, Parathyroid Diseases
- What is being tested?
- Palopegteriparatide Experimental Arm
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 9 sitesUnited States
- Study dates
- 7 May 2026to Jun 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, ≥18 years of age at the time of providing informed consent
- Participants with postsurgical chronic hypoparathyroidism (HP), or auto-immune, genetic, or idiopathic HP, for at least 26 weeks
- Receiving doses of palopegteriparatide at or above 30 µg/day
- For individuals receiving 30 µg/day: evidence that dose is insufficient to keep serum calcium in the normal range, defined as:
- Documented hypocalcemia within 12 weeks prior to Screening; and/or Standing dose of calcitriol ≥0.25 μg/day, and / or (elemental) calcium ≥1500 mg/day (e.g., calcium citrate, calcium carbonate etc.) for at least 4 weeks prior to Screening
- For individuals receiving 33 µg/day or greater: no requirement for documented hypocalcemia or minimum doses of calcitriol or elemental calcium
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- Confirmation of laboratory parameters (Central or Local) within 2 weeks of screening visit and prior to randomization:
- 25(OH) vitamin D levels of ≥ 20 ng/mL (≥49 nmol/L) and Magnesium level in the normal range, or just below the normal range i.e.: ≥1.3 mg/dL (≥0.53 mmol/L) and Albumin-adjusted or ionized sCa level in the normal range or just below the normal range
- Albumin-adjusted sCa 7.8 - 10.6 mg/dL (or 1.95 - 2.64 mmol/L)
- Ionized sCa 4.40 - 5.29 mg/dL (1.10 - 1.32 mmol/L)
- 5. BMI 17- 40 kg/m2 at Screening
- 6. If ≤25 years of age, radiological evidence of epiphyseal closure based on locally interpreted X-ray of non-dominant wrist and hand
- 7. eGFR ≥30 mL/min/1.73 m2 during Screening using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
Who cannot join
- Impaired responsiveness to PTH (pseudohypoparathyroidism), 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 HP
- 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)
- Use of thiazide diuretic within 4 weeks prior to the 24-hour urine collection scheduled to occur within 1 week prior to Visit 1
- Use of PTH-like drugs other than palopegteriparatide (whether commercially available or through participation in an investigational trial), including PTH(1-34), or other N-terminal fragments, analogs of PTH or PTH-related protein, or PTH1R biased agonists within 4 weeks prior to Screening
- Use of drugs known to influence calcium and bone metabolism within 12 weeks prior to Screening
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- Use of denosumab or romosozumab within 2 years prior to Screening. Use of raloxifene within 4 weeks prior to Screening.
- Non-hypocalcemic seizure disorder with occurrence of a seizure within 26 weeks prior to Screening.
- Increased risk for osteosarcoma
- Women who are pregnant, intend to become pregnant, or are lactating
- Diagnosed drug or alcohol dependence within 3 years prior to Screening
- Chronic or severe cardiac disease within 26 weeks prior to Screening
- Cerebrovascular accident within 5 years prior to Screening.
- Within 26 weeks prior to Screening: acute colic due to nephrolithiasis, or acute gout
- Participation in any other interventional trial in which receipt of investigational drug or device other than palopegteriparatide occurred within 8 weeks (or within 5.5 times the half-life of the investigational drug) (whichever comes first) prior to Screening.
- Known allergy or sensitivity to PTH or any of the excipients [metacresol, mannitol, succinic acid, NaOH/(HCl)] of the investigational product
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Ascendis Pharma Investigational Site
Chicago, Illinois, 60637
- Recruiting
Ascendis Pharma Investigational Site
Greeley, Colorado, 80634
- Recruiting
Ascendis Pharma Investigational Site
Greenville, North Carolina, 27834
- Recruiting
Ascendis Pharma Investigational Site
Houston, Texas, 77030
- Recruiting
Ascendis Pharma Investigational Site
Minneota, Minnesota, 55905
- Recruiting
Ascendis Pharma Investigational Site
New York, New York, 10022
- Recruiting
Ascendis Pharma Investigational Site
New York, New York, 10032
- Recruiting
Ascendis Pharma Investigational Site
Reno, Nevada, 89511
- Recruiting
Ascendis Pharma Investigational Site
Spokane Valley, Washington, 99216
About this study
Official title: A Phase 3, Multicenter, Randomized, Open-Label Trial Investigating the Safety, Tolerability and Efficacy of Palopegteriparatide Administered Subcutaneously Daily at Doses Greater Than 30 μg/Day in Adult Participants With Hypoparathyroidism
This trial has a treatment duration of 78 weeks and will include adult participants already on treatment with palopegteriparatide at doses at or greater than 30 mcg/day. All participants will receive subcutaneous palopegteriparatide during the trial and will be individually and progressively titrated to an optimal dose at pre-specified dose levels. The primary purpose of the trial is to provide additional evidence of treatment effect and safety of palopegteriparatide at doses greater than 30 mcg/day in adults with hypoparathyroidism. The trial will be conducted in the US.
- Being tested
- Palopegteriparatide Experimental Arm, Palopegteriparatide Control Arm
- Keywords
- Hypoparathyroidism, Parathyroid Hormone, TransCon PTH, PTH(1-34), Prodrug, Sustained Release, Parathyroid Hormone Replacement Therapy, Palopegteriparatide
- Medical subject headings
- Hypoparathyroidism, Endocrine System Diseases, Parathyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palopegteriparatide Experimental ArmCombination product
Also called Yorvipath
Palopegteriparatide is administered as separate SC injection in a prefilled, single-patient use pen. Treatment duration 78 weeks.
Palopegteriparatide Control ArmCombination product
Also called Yorvipath
Palopegteriparatide is administered as separate SC injection in a prefilled, single-patient use pen. Treatment duration 78 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Palopegteriparatide Experimental Arm | Experimental | Palopegteriparatide administered once daily by subcutaneous injection and titrated to an optimal dose by a novel titration algorithm. Receives: Combination Product: Palopegteriparatide Experimental Arm |
| Palopegteriparatide Control Arm | Active comparator | Palopegteriparatide administered once daily by subcutaneous injection and titrated to an optimal dose by a previously evaluated titrated algorithm Receives: Combination Product: Palopegteriparatide Control Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - Primary endpoint
The proportion of participants with:
Albumin-adjusted serum calcium (sCa) measured within 4 weeks prior to and on the Week 26 visit within the normal range (8.3-10.6 mg/dL); and independence from active vitamin D; and independence from therapeutic doses of calcium; and no increase in prescribed investigational product within 4 weeks prior to Week 26 visit.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start7 May 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label randomized multi-center
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascendis Pharma Bone Diseases 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
- NCT07081997
- Sponsor's protocol ID
- ASND0052
- Acronym
- PaTHway60
- Status last verified
- Oct 2026
- First submitted
- 22 Jul 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Open-Label Trial Investigating the Safety, Tolerability and Efficacy of Palopegteriparatide Administered Subcutaneously Daily at Doses Greater Than 30 μg/Day in Adult Participants With Hypoparathyroidism
- ClinicalTrials.gov ID
- NCT07081997
- Acronym / sponsor ID
- PaTHway60 / ASND0052
- Keywords
- Hypoparathyroidism, Parathyroid Hormone, TransCon PTH, PTH(1-34), Prodrug, Sustained Release, Parathyroid Hormone Replacement Therapy, Palopegteriparatide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Ascendis Pharma Bone Diseases A/SIndustry (pharma, biotech, devices)
- Study start
- 7 May 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 24 Jul 2025 (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 has a treatment duration of 78 weeks and will include adult participants already on treatment with palopegteriparatide at doses at or greater than 30 mcg/day. All participants will receive subcutaneous palopegteriparatide during the trial and will be individually and progressively titrated to an optimal dose at pre-specified dose levels. The primary purpose of the trial is to provide additional evidence of treatment effect and safety of palopegteriparatide at doses greater than 30 mcg/day in adults with hypoparathyroidism. The trial will be conducted in the US.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label randomized multi-center
| Arm | Type | Receives |
|---|---|---|
| Palopegteriparatide Experimental Arm | Experimental | Combination Product: Palopegteriparatide Experimental ArmPalopegteriparatide administered once daily by subcutaneous injection and titrated to an optimal dose by a novel titration algorithm. |
| Palopegteriparatide Control Arm | Active comparator | Combination Product: Palopegteriparatide Control ArmPalopegteriparatide administered once daily by subcutaneous injection and titrated to an optimal dose by a previously evaluated titrated algorithm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Males and females, ≥18 years of age at the time of providing informed consent
- Participants with postsurgical chronic hypoparathyroidism (HP), or auto-immune, genetic, or idiopathic HP, for at least 26 weeks
- Receiving doses of palopegteriparatide at or above 30 µg/day
- For individuals receiving 30 µg/day: evidence that dose is insufficient to keep serum calcium in the normal range, defined as:
- Documented hypocalcemia within 12 weeks prior to Screening; and/or Standing dose of calcitriol ≥0.25 μg/day, and / or (elemental) calcium ≥1500 mg/day (e.g., calcium citrate, calcium carbonate etc.) for at least 4 weeks prior to Screening
Key exclusion criteria (16 listed)
- Impaired responsiveness to PTH (pseudohypoparathyroidism), 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 HP
- 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)
- Use of thiazide diuretic within 4 weeks prior to the 24-hour urine collection scheduled to occur within 1 week prior to Visit 1
- Use of PTH-like drugs other than palopegteriparatide (whether commercially available or through participation in an investigational trial), including PTH(1-34), or other N-terminal fragments, analogs of PTH or PTH-related protein, or PTH1R biased agonists within 4 weeks prior to Screening
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 |
|---|---|---|
| Palopegteriparatide Experimental ArmAlso: YorvipathPalopegteriparatide is administered as separate SC injection in a prefilled, single-patient use pen. Treatment duration 78 weeks. | Combination product | Palopegteriparatide Experimental Arm |
| Palopegteriparatide Control ArmAlso: YorvipathPalopegteriparatide is administered as separate SC injection in a prefilled, single-patient use pen. Treatment duration 78 weeks. | Combination product | Palopegteriparatide Control Arm |
Primary outcome
Efficacy - Primary endpoint
Time frame: 26 weeks
The proportion of participants with: Albumin-adjusted serum calcium (sCa) measured within 4 weeks prior to and on the Week 26 visit within the normal range (8.3-10.6 mg/dL); and independence from active vitamin D; and independence from therapeutic doses of calcium; and no increase in prescribed investigational product within 4 weeks prior to Week 26 visit.
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 20 Oct 2026.
- Individual participant dataSharing planned: No
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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
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Palopegteriparatide Experimental Arm in people with Hypoparathyroidism and Endocrine System Diseases, run by Ascendis Pharma Bone Diseases A/S at 9 sites in United States.
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 13 inclusion and 16 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 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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 (+4561161658, asnd_registryinquiries@ascendispharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy - Primary endpoint (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 20 Oct 2026.