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NCT Number: NCT07264634

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.

Recruiting

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Key information

Conditions

Hypoparathyroidism Endocrine System Diseases Parathyroid Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Ascendis Investigational Site

Morgantown, West Virginia, 26508, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palopegteriparatide

Drug

Palopegteriparatide prescribed as per normal clinical practice

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

    Time frame: 6 days

Study contacts

Contact information is provided by the study sponsor or research team.

Yorvipath Lactation Inquiries

CONTACT

[email protected]

877-229-2184

Sponsors and collaborators

Lead sponsor

Ascendis Pharma A/S

Industry

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 4, 2025
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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