Recruiting

Yorvipath

Sponsor:

Ascendis Pharma A/S

Code:

NCT07264634

Conditions

Hypoparathyroidism

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Palopegteriparatide

Study Details

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

Study ID

NCT07264634

Start date

Mar 19, 2026

Status verified date

Aug, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Arms

Palopegteriparatide

Pregnant women exposed to palopegteriparatide during pregnancy

Interventions

Palopegteriparatide

Palopegteriparatide prescribed as per normal clinical practice

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Yorvipath Lactation Inquiries

877-229-2184yorvipathlactation@ubc.com

Locations

Ascendis Investigational Site

Recruiting

Morgantown, West Virginia, United States, 26508

More Information

Sponsor

Ascendis Pharma A/S

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ascendis Pharma A/S on 2026-08-07.