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Investigating Palopegteriparatide Doses for Hypoparathyroidism

This study is looking into the safety and effectiveness of higher doses of palopegteriparatide for adults with hypoparathyroidism (a condition where your body doesn't make enough parathyroid hormone). You might be able to join if you are 18 or older, have had hypoparathyroidism for at least 26 weeks, and are already taking palopegteriparatide at 30 micrograms per day or more. All participants will receive palopegteriparatide through injections under the skin, and your dose will be adjusted to find what works best for you. The main goal is to see how well palopegteriparatide works and if it's safe at these higher doses. The study's success will be measured after 26 weeks of treatment. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 36 adult participants. All participants will receive palopegteriparatide.
What's involved
You would participate in this trial for 78 weeks, receiving subcutaneous injections of palopegteriparatide with individualized dose adjustments.
Compensation
Not stated in the trial record.
Follow-up
The primary effectiveness of the treatment will be measured at 26 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07081997

A Phase 3 Randomized Clinical Trial to Investigate the Safety and Efficacy of Palopegteriparatide at Doses Greater Than 30 μg/Day in Adult Participants With Hypoparathyroidism

Recruiting
PHASE3Ages 18+InterventionalTreatment
Ascendis Pharma Bone Diseases A/S
~36 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Palopegteriparatide Experimental ArmPalopegteriparatide Control Arm

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy - Primary endpoint
Measured over 26 weeks

Conditions

Hypoparathyroidism
Endocrine System Diseases
Parathyroid Diseases

Explore related trials

Hypoparathyroidism

Where it's being run

7 sites across 7 states
Illinois1
Minnesota1
Nevada1
New York1
North Carolina1
Texas1
Washington1

Study leadership

  • Medical Director, MD · STUDY_DIRECTOR · Ascendis Pharma A/S

Who to contact

Ascendis Registry Inquiries
[email protected]
+4561161658
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Albumin-adjusted sCa 7.8 - 10.6 mg/dL (or 1.95 - 2.64 mmol/L)
Ionized sCa 4.40 - 5.29 mg/dL (1.10 - 1.32 mmol/L)

What this trial measures

  • Efficacy - Primary endpoint26 weeks

    The proportion of participants with: Albumin-adjusted serum calcium (sCa) measured within 4 weeks prior to and on the Week 26 visit within the normal range (8.3-10.6 mg/dL); and independence from active vitamin D; and independence from therapeutic doses of calcium; and no increase in prescribed investigational product within 4 weeks prior to Week 26 visit.