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

NCT07264634 | Recruiting FDA Drug

• 1 other identifier: ASND0044
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoparathyroidism

Outcome Measures

Primary Outcomes (1)

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

  6 days

Study Arms (1)

Palopegteriparatide

Pregnant women exposed to palopegteriparatide during pregnancy

Drug: Palopegteriparatide

Interventions

Palopegteriparatide DRUG

Palopegteriparatide prescribed as per normal clinical practice

Palopegteriparatide

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• \. 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.
• \. 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).
• \. Daily dose of YORVIPATH administered within the last 14 days has been stable.
• \. Participants recruited from other sources must enroll in the Pregnancy Registry before being allowed to participate in the Lactation Study.
• \. Written consent or eConsent obtained.

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Ascendis Pharma A/S: lead

Study Sites (1)

Ascendis Investigational Site

Morgantown, West Virginia, 26508, United States

RECRUITING

MeSH Terms

Conditions

Hypoparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Medical Director, MD

  Ascendis Pharma A/S

  STUDY DIRECTOR

Central Study Contacts

Yorvipath Lactation Inquiries

CONTACT

877-229-2184; yorvipathlactation@ubc.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: March 19, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (1)