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RecruitingNCT07264634Updated Aug 7, 2026

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

An observational study in Hypoparathyroidism, sponsored by Ascendis Pharma A/S. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Ascendis Pharma A/S · Observational

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years to 50 Years
Sex
Female
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Study 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.

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Conditions studied

  • Hypoparathyroidism

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03

In context

Hypoparathyroidism

128 studies on the registry are indexed under Hypoparathyroidism; 30 are open to participants now.

This study's planned enrollment of 10 is below the median of 147 across 48 observational studies indexed under Hypoparathyroidism.

Browse Hypoparathyroidism studies →

Lead sponsor

Ascendis Pharma A/S is the lead sponsor of 17 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Target follow-up
6 Days
Patient registry
Yes

Groups and cohorts

  • Palopegteriparatide

    Pregnant women exposed to palopegteriparatide during pregnancy

    Drug: Palopegteriparatide

Interventions

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What researchers measure

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

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Study locations

1 of 1 sites recruiting
  • Ascendis Investigational Site
    Morgantown, West Virginia 26508, United States
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Aug 2027, 17 months after the start.

Of 25 observational studies under Hypoparathyroidism, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 122. This study's planned 17 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 24, 2025
First posted
Dec 4, 2025
StartActual
Mar 19, 2026
Primary completionEst.
Aug 2027
CompletionEst.
Aug 2027
Last update
Aug 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07264634
Lead sponsor
Ascendis Pharma A/S
Responsible party
Sponsor
First posted
Dec 4, 2025
Start date
Mar 19, 2026
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Aug 7, 2026

Study contacts

Yorvipath Lactation Inquiries
Contact
yorvipathlactation@ubc.com
877-229-2184
Medical Director, MD
study director · Ascendis Pharma A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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