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

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 Overview

• Status: Recruiting
• Conditions: Hypoparathyroidism
• Intervention / Treatment: Drug: Palopegteriparatide

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Yorvipath Pregnancy Inquiries; Phone Number: 877-229-2184; Email: yorvipathpregnancy@ubc.com

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26508
      • Recruiting
      • Ascendis Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Palopegteriparatide; Pregnant women exposed to palopegteriparatide during pregnancy	Drug: Palopegteriparatide; Palopegteriparatide prescribed as per normal clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of fetuses as reported by HCP		21 months
Pregnancy outcomes	Live birth (preterm delivery, full-term delivery); Spontaneous abortion; Pregnancy termination; Fetal death/stillbirth; Molar or ectopic pregnancy	21 months
Number of congenital malformations identified in the developing fetus, neonate, or infant		21 months
Descriptive statistics of adverse events (AEs), including serious adverse events (SAEs)		21 months
Number of hospitalizations including reasons for hospitalization		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		21 months
Number of signs of hypocalcemia or hypercalcemia		21 months
Descriptive statistics of infant developmental deficiency (CDC 2021)		21 months
Descriptive statistics of postnatal growth deficiency or failure to thrive (FTT)		21 months
Descriptive statistics of neonatal and infant mortality		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)	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	21 months

Collaborators and Investigators

• Sponsor: Ascendis Pharma A/S
• Investigators: Study Director: Medical Director, MD, Ascendis Pharma A/S

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2026
• Primary Completion (Estimated): January 1, 2036
• Study Completion (Estimated): January 1, 2036

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hypoparathyroidism
• Other Study ID Numbers: ASND0043

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No