Palopegteriparatide levels in breast milk of lactating individuals taking YORVIPATH.
Official title: A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide)
Run by Ascendis Pharma A/S · NCT07264634 · Data updated 2026-11-12
This will see if palopegteriparatide (YORVIPATH) appears in the breast milk of lactating adults with hypoparathyroidism who are breastfeeding.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 10 (estimated) |
| Sponsor | Ascendis Pharma A/S Industry-sponsored |
| Locations | 1 site (Morgantown, West Virginia) |
| Status | Recruiting |
| Started | March 19, 2026 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | August 7, 2026 |
| Trial ID | NCT07264634 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Ascendis Investigational Site
Morgantown, West Virginia, United States Recruiting
Study contacts
- Study coordinator: Yorvipath Lactation Inquiries
- Email: yorvipathlactation@ubc.com
- Phone: 877-229-2184
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
German Hypoparathyroidism Registry
This registry in Germany collects information from adults with chronic hypoparathyroidism or pseudohypoparathyroidism to better understand how the condition affects people over time and to support future research.
-
Encaleret for Chronic Hypoparathyroidism: Testing if it helps symptoms and safety
This study tests whether taking encaleret pills can help people with chronic hypoparathyroidism, while being safe and tolerable.
-
Palopegteriparatide in adolescents with long-term hypoparathyroidism
This study tests whether a once-daily palopegteriparatide shot helps adolescents with long‑standing hypoparathyroidism and whether it’s safe for them.
-
Canvuparatide vs placebo in adults with hypoparathyroidism
This study tests whether weekly canvuparatide can help adults with hypoparathyroidism feel better and keep calcium levels steady compared with a placebo.
-
NIRAF-guided identification of parathyroids during thyroidectomy
A wearable near-infrared autofluorescence device is being tested to help surgeons find and protect the parathyroid glands during thyroid surgery in adults.
-
Pregnancy registry tracking outcomes after YORVIPATH exposure during pregnancy and breastfeeding
This registry collects information from pregnant or breastfeeding people with hypoparathyroidism who took YORVIPATH to see if the exposure affects pregnancy, the baby, or infant outcomes through the first year of life.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.