A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide)

This is an observational, opportunistic lactation study to be conducted in lactating female participants who are currently receiving therapeutic doses of YORVIPATH as part of their usual care and who have chosen to breastfeed their infant(s). The potential transfer of palopegteriparatide into breast milk will be assessed.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Yorvipath Lactation Inquiries; Phone Number: 877-229-2184; Email: yorvipathlactation@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: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Eligible females will be actively recruited from the US participants in the pregnancy registry. Females in the US who want to participate in the lactation study must first enroll in the pregnancy registry and meet the lactation study eligibility criteria study to participate. Females may self enroll into the study or may be enrolled by their healthcare provider (HCP).

Description

Inclusion Criteria:

• 1. Lactating female participants 18 years of age or older treated with YORVIPATH as part of their usual medical care and who have chosen to breastfeed. Note: The participant must have been taking YORVIPATH for a minimum of 14 days prior to sample collection.
• 2. The major source of infant nutrition must be breast milk (Note: Only one supplemental bottle of no more than up to 8 oz of formula per day will be allowed during the 14 days before start of the study).
• 3. Daily dose of YORVIPATH administered within the last 14 days has been stable.
• 4. Participants recruited from other sources must enroll in the Pregnancy Registry before being allowed to participate in the Lactation Study.
• 5. Written consent or eConsent obtained.

Exclusion Criteria:

• 1. Presence of any medical condition that, in the opinion of the investigator, may impair the ability to breastfeed during this study, including but not limited to mastitis and nipple malformation

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	Time Frame
To evaluate the transfer of palopegteriparatide into human breast milk of lactating female participants who are breastfeeding while being treated with YORVIPATH	6 days

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): March 19, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hypoparathyroidism
• Other Study ID Numbers: ASND0044

Drug and device information, study documents

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