CClinicalTrials.gg
RecruitingNCT07345494Updated Mar 2, 2026

A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding

An observational study in Hypoparathyroidism, sponsored by Ascendis Pharma A/S. Recruiting at 1 site in United States. Open to female participants aged 15 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-03-02.

Sponsored by Ascendis Pharma A/S · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
50
Ages
15 Years to 50 Years
Sex
Female
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Study 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 first year of life.

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Conditions studied

  • Hypoparathyroidism

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Who can participate

Ages eligible
15 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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

Exclusion Criteria:

  • Pregnancies in which only the male partner is exposed to at least one dose of YORVIPATH.
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
50 participants (estimated)
Target follow-up
21 Months
Patient registry
Yes

Groups and cohorts

  • Palopegteriparatide

    Pregnant women exposed to palopegteriparatide during pregnancy

    Drug: Palopegteriparatide

Interventions

  • DrugPalopegteriparatide

    Palopegteriparatide prescribed as per normal clinical practice

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What researchers measure

Primary outcomes

  1. The number of fetuses as reported by HCP

    Time frame: 21 months

  2. Pregnancy outcomes

    * Live birth (preterm delivery, full-term delivery) * Spontaneous abortion * Pregnancy termination * Fetal death/stillbirth * Molar or ectopic pregnancy

    Time frame: 21 months

  3. Number of congenital malformations identified in the developing fetus, neonate, or infant

    Time frame: 21 months

  4. Descriptive statistics of adverse events (AEs), including serious adverse events (SAEs)

    Time frame: 21 months

  5. Number of hospitalizations including reasons for hospitalization

    Time frame: 21 months

  6. 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

  7. Number of signs of hypocalcemia or hypercalcemia

    Time frame: 21 months

  8. Descriptive statistics of infant developmental deficiency (CDC 2021)

    Time frame: 21 months

  9. Descriptive statistics of postnatal growth deficiency or failure to thrive (FTT)

    Time frame: 21 months

  10. Descriptive statistics of neonatal and infant mortality

    Time frame: 21 months

  11. 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)

    Time frame: 21 months

  12. 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

    Time frame: 21 months

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Study locations

1 of 1 sites recruiting
  • Ascendis Investigational Site
    Morgantown, West Virginia 26508, United States
    Recruiting
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Registry details

Key details

Study ID
NCT07345494
Lead sponsor
Ascendis Pharma A/S
Responsible party
Sponsor
First posted
Jan 15, 2026
Start date
Feb 18, 2026
Primary completion
Jan 2036 (estimated)
Completion
Jan 2036 (estimated)
Last update
Mar 2, 2026

Study contacts

Yorvipath Pregnancy Inquiries
Contact
yorvipathpregnancy@ubc.com
877-229-2184
Medical Director, MD
study director · Ascendis Pharma A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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