Palopegteriparatide levels in breast milk of lactating individuals taking YORVIPATH.
A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide)
This will see if palopegteriparatide (YORVIPATH) appears in the breast milk of lactating adults with hypoparathyroidism who are breastfeeding.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Ascendis Pharma A/S Industry-sponsored |
| Locations | 1 site (Morgantown, West Virginia) |
| Trial ID | NCT07264634 on ClinicalTrials.gov |
What this trial studies
This is an observational, opportunistic lactation study enrolling lactating adults who are already receiving YORVIPATH as part of their usual care. Participants must have been on a stable daily dose for at least 14 days and provide breast milk samples for drug concentration testing. The study will measure palopegteriparatide levels in breast milk to estimate infant exposure during routine breastfeeding. Participants recruited outside the site must also enroll in the sponsor's pregnancy registry prior to participation.
Who should consider this trial
Good fit: Lactating adults aged 18 or older with hypoparathyroidism who have been on a stable daily dose of YORVIPATH for at least 14 days and whose infant's main nutrition is breast milk are ideal candidates.
Not a fit: People who are not breastfeeding, cannot provide regular milk samples, or have conditions that impair breastfeeding (for example mastitis or nipple malformation) are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could provide data to guide breastfeeding recommendations and inform infant exposure risk for people taking YORVIPATH.
How similar studies have performed: Pharmacokinetic lactation studies are a standard method to measure drug transfer into milk, but measuring palopegteriparatide specifically in human breast milk is novel and not broadly reported in the literature.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Morgantown, West Virginia
- Ascendis Investigational Site — Morgantown, West Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Yorvipath Lactation Inquiries
- Email: yorvipathlactation@ubc.com
- Phone: 877-229-2184
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.