Pregnancy registry tracking outcomes after YORVIPATH exposure during pregnancy and breastfeeding
Official title: A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding
Run by Ascendis Pharma A/S · NCT07345494 · Data updated 2026-11-12
This registry collects information from pregnant or breastfeeding people with hypoparathyroidism who took YORVIPATH to see if the exposure affects pregnancy, the baby, or infant outcomes through the first year of life.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 15 Years to 50 Years |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | Ascendis Pharma A/S Industry-sponsored |
| Locations | 1 site (Morgantown, West Virginia) |
| Status | Recruiting |
| Started | February 18, 2026 |
| Main results expected | January 2036 |
| Study ends | January 2036 |
| Registry record updated | March 2, 2026 |
| Trial ID | NCT07345494 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 15–50 with hypoparathyroidism who received at least one dose of YORVIPATH within 15 days before conception or at any time during pregnancy and who can provide consent and a medical release.
✕Probably not a fit
People who were not exposed to YORVIPATH during the specified window or pregnancies where only the male partner was exposed are not eligible and would not benefit from this registry's findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational registry collecting both prospective and retrospective data on people with hypoparathyroidism who were exposed to YORVIPATH during pregnancy or within the 15 days before conception. Data will include pregnancy and maternal complications, fetal and neonatal outcomes, and infant follow-up through at least the first year of life, using medical records and participant-provided information. Participants must provide consent (or assent with guardian consent for minors) and a medical release of information to allow data collection. The registry is sponsored by Ascendis Pharma and lists enrollment through the Ascendis Investigational Site in Morgantown, West Virginia.
Why it matters
Potential benefit: If successful, the registry could provide clearer safety information to help pregnant people and clinicians make informed treatment and counseling decisions about YORVIPATH use.
How similar studies have gone: Pregnancy registries for other medications have helped identify safety signals and guide counseling, but pregnancy-specific data for YORVIPATH are novel and limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Pregnancies in which only the male partner is exposed to at least one dose of YORVIPATH.
Where it's running
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Ascendis Investigational Site
Morgantown, West Virginia, United States Recruiting
Study contacts
- Study coordinator: Yorvipath Pregnancy Inquiries
- Email: yorvipathpregnancy@ubc.com
- Phone: 877-229-2184
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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German Hypoparathyroidism Registry
This registry in Germany collects information from adults with chronic hypoparathyroidism or pseudohypoparathyroidism to better understand how the condition affects people over time and to support future research.
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Encaleret for Chronic Hypoparathyroidism: Testing if it helps symptoms and safety
This study tests whether taking encaleret pills can help people with chronic hypoparathyroidism, while being safe and tolerable.
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Palopegteriparatide in adolescents with long-term hypoparathyroidism
This study tests whether a once-daily palopegteriparatide shot helps adolescents with long‑standing hypoparathyroidism and whether it’s safe for them.
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Canvuparatide vs placebo in adults with hypoparathyroidism
This study tests whether weekly canvuparatide can help adults with hypoparathyroidism feel better and keep calcium levels steady compared with a placebo.
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NIRAF-guided identification of parathyroids during thyroidectomy
A wearable near-infrared autofluorescence device is being tested to help surgeons find and protect the parathyroid glands during thyroid surgery in adults.
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Palopegteriparatide levels in breast milk of lactating individuals taking YORVIPATH.
This will see if palopegteriparatide (YORVIPATH) appears in the breast milk of lactating adults with hypoparathyroidism who are breastfeeding.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.