HypoparathyroidismNCT07345494
A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding
An observational study of Hypoparathyroidism, run by Ascendis Pharma A/S at 1 site in United States.
Trial summary
The purpose of this registry study is to collect both prospective and retrospective data in women exposed to palopegteriparatide during pregnancy to assess risk of pregnancy and maternal complications, and adverse effects on the developing fetus, neonate, and infant and to assess infant outcomes through at least the… Read more about this study
- Who is it for?
- Ages 15 to 50 years, women only
- Conditions the study is for
- Hypoparathyroidism
- What is being tested?
- Palopegteriparatide
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2026to Jan 2036
- How long will I take part?
- 21 Months
- Phase
- Observational
- 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 15 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Participants with exposure to at least one dose of YORVIPATH at any time within 15 days prior to conception or during pregnancy. Prospective and retrospective pregnancies may be reported.
Who may be able to join
- Participants aged 15 to 50 years
- Participants with exposure to at least one dose of YORVIPATH at any time within 15 days prior to conception and/or during pregnancy. The timeframe of 15 days prior to conception is calculated based on 5 times the YORVIPATH half life of ~ 60 hours
- Participants providing written informed consent, verbal consent, or eConsent (depending on country regulations) and a Medical Release of Information. For adolescents under the age of majority, verbal or written informed assent by the pregnant minor (where applicable) and verbal or written informed consent by the parent/legal guardian will be obtained.
Who cannot join
- Pregnancies in which only the male partner is exposed to at least one dose of YORVIPATH.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ascendis Investigational Site
Morgantown, West Virginia, 26508
About this study
The purpose of this registry study is to collect both prospective and retrospective data in women exposed to palopegteriparatide during pregnancy to assess risk of pregnancy and maternal complications, and adverse effects on the developing fetus, neonate, and infant and to assess infant outcomes through at least the first year of life.
- 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.
PalopegteriparatideDrug
Palopegteriparatide prescribed as per normal clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Palopegteriparatide | Pregnant women exposed to palopegteriparatide during pregnancy Receives: Drug: Palopegteriparatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of fetuses as reported by HCP
Measured: 21 months
Pregnancy outcomes
- Live birth (preterm delivery, full-term delivery)
- Spontaneous abortion
- Pregnancy termination
- Fetal death/stillbirth
- Molar or ectopic pregnancy
Measured: 21 months
Number of congenital malformations identified in the developing fetus, neonate, or infant
Measured: 21 months
Descriptive statistics of adverse events (AEs), including serious adverse events (SAEs)
Measured: 21 months
Number of hospitalizations including reasons for hospitalization
Measured: 21 months
Descriptive statistics of growth and development milestones as described by the Centers for Disease Control and Prevention (CDC 2021) or other accepted standard assessment
Measured: 21 months
Number of signs of hypocalcemia or hypercalcemia
Measured: 21 months
Descriptive statistics of infant developmental deficiency (CDC 2021)
Measured: 21 months
Descriptive statistics of postnatal growth deficiency or failure to thrive (FTT)
Measured: 21 months
Descriptive statistics of neonatal and infant mortality
Measured: 21 months
Maternal complications of pregnancy
Including but not limited to
- Premature rupture of membranes (PROM)
- Preterm PROM (PPROM)
- Pre-eclampsia
- Gestational hypertension
- Eclampsia
- Proteinuria
- Gestational diabetes
- Intrauterine growth restriction (IUGR)
- Polyhydramnios
- Preterm delivery
- Measures of fetal growth deficiency (e.g., small for gestational age)
Measured: 21 months
Other maternal events of interest
Number of
- AEs, including SAEs
- Events specific to hypoparathyroidism (e.g., hypercalcemia, hypocalcemia). Serum calcium concentrations at each trimester (if available) and at birth
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start18 Feb 2026
- Primary completionJan 2036 (estimated)
- Study completionJan 2036 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
- Target duration
- 21 Months
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
- NCT07345494
- Sponsor's protocol ID
- ASND0043
- Status last verified
- Feb 2026
- First submitted
- 24 Nov 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding
- ClinicalTrials.gov ID
- NCT07345494
- Acronym / sponsor ID
- ASND0043
- Conditions
- Hypoparathyroidism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ascendis Pharma A/SIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- Jan 2036 (estimated)
- Study completion
- Jan 2036 (estimated)
- First posted
- 15 Jan 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.
The purpose of this registry study is to collect both prospective and retrospective data in women exposed to palopegteriparatide during pregnancy to assess risk of pregnancy and maternal complications, and adverse effects on the developing fetus, neonate, and infant and to assess infant outcomes through at least the first year of life.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 21 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palopegteriparatide | – | Drug: PalopegteriparatidePregnant women exposed to palopegteriparatide during pregnancy |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants with exposure to at least one dose of YORVIPATH at any time within 15 days prior to conception or during pregnancy. Prospective and retrospective pregnancies may be reported.
Key inclusion criteria (3 listed)
- Participants aged 15 to 50 years
- Participants with exposure to at least one dose of YORVIPATH at any time within 15 days prior to conception and/or during pregnancy. The timeframe of 15 days prior to conception is calculated based on 5 times the YORVIPATH half life of ~ 60 hours
- Participants providing written informed consent, verbal consent, or eConsent (depending on country regulations) and a Medical Release of Information. For adolescents under the age of majority, verbal or written informed assent by the pregnant minor (where applicable) and verbal or written informed consent by the parent/legal guardian will be obtained.
Key exclusion criteria (1 listed)
- Pregnancies in which only the male partner is exposed to at least one dose of YORVIPATH.
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 |
|---|---|---|
| PalopegteriparatidePalopegteriparatide prescribed as per normal clinical practice | Drug | Palopegteriparatide |
Primary outcome
The number of fetuses as reported by HCP
Time frame: 21 months
Pregnancy outcomes
Time frame: 21 months
* Live birth (preterm delivery, full-term delivery) * Spontaneous abortion * Pregnancy termination * Fetal death/stillbirth * Molar or ectopic pregnancy
Number of congenital malformations identified in the developing fetus, neonate, or infant
Time frame: 21 months
Descriptive statistics of adverse events (AEs), including serious adverse events (SAEs)
Time frame: 21 months
Number of hospitalizations including reasons for hospitalization
Time frame: 21 months
Descriptive statistics of growth and development milestones as described by the Centers for Disease Control and Prevention (CDC 2021) or other accepted standard assessment
Time frame: 21 months
Number of signs of hypocalcemia or hypercalcemia
Time frame: 21 months
Descriptive statistics of infant developmental deficiency (CDC 2021)
Time frame: 21 months
Descriptive statistics of postnatal growth deficiency or failure to thrive (FTT)
Time frame: 21 months
Descriptive statistics of neonatal and infant mortality
Time frame: 21 months
Maternal complications of pregnancy
Time frame: 21 months
Including but not limited to * Premature rupture of membranes (PROM) * Preterm PROM (PPROM) * Pre-eclampsia * Gestational hypertension * Eclampsia * Proteinuria * Gestational diabetes * Intrauterine growth restriction (IUGR) * Polyhydramnios * Preterm delivery * Measures of fetal growth deficiency (e.g., small for gestational age)
Other maternal events of interest
Time frame: 21 months
Number of * AEs, including SAEs * Events specific to hypoparathyroidism (e.g., hypercalcemia, hypocalcemia). Serum calcium concentrations at each trimester (if available) and at birth
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 2 Mar 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoparathyroidism, run by Ascendis Pharma A/S at 1 site 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 3 inclusion and 1 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 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 Yorvipath Pregnancy Inquiries (877-229-2184, yorvipathpregnancy@ubc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of fetuses as reported by HCP (time frame: 21 months). The study lists 12 primary outcomes in all. 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 2 Mar 2026.