HypoparathyroidismNCT07264634
A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide)
An observational study of Hypoparathyroidism, run by Ascendis Pharma A/S at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Hypoparathyroidism
- What is being tested?
- Palopegteriparatide
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2026to Aug 2027
- How long will I take part?
- 6 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
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).
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ascendis Investigational Site
Morgantown, West Virginia, 26508
About this study
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
- Being tested
- Palopegteriparatide
- Medical subject headings
- Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalopegteriparatideDrug
Palopegteriparatide prescribed as per normal clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Palopegteriparatide | Pregnant women exposed to palopegteriparatide during pregnancy Receives: Drug: Palopegteriparatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the transfer of palopegteriparatide into human breast milk of lactating female participants who are breastfeeding while being treated with YORVIPATH
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start19 Mar 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 6 Days
Sponsor and investigators
- Lead sponsor
- Ascendis Pharma A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Ascendis Pharma A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264634
- Sponsor's protocol ID
- ASND0044
- Status last verified
- Aug 2026
- First submitted
- 24 Nov 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide)
- ClinicalTrials.gov ID
- NCT07264634
- Acronym / sponsor ID
- ASND0044
- Conditions
- Hypoparathyroidism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ascendis Pharma A/SIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palopegteriparatide | – | Drug: PalopegteriparatidePregnant women exposed to palopegteriparatide during pregnancy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PalopegteriparatidePalopegteriparatide prescribed as per normal clinical practice | Drug | Palopegteriparatide |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director, MD study director
Ascendis Pharma A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoparathyroidism, run by Ascendis Pharma A/S at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yorvipath Lactation Inquiries (877-229-2184, yorvipathlactation@ubc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.