Actively Recruiting
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
Led by Ascendis Pharma Bone Diseases A/S · Updated on 2026-05-04
36
Participants Needed
3
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial has a duration of 78 weeks and will include adult participants already on treatment with palopegteriparatide at doses at or greater than 30 mcg/day. All participants will receive subcutaneous palopegteriparatide during the trial and will be individually and progressively titrated to an optimal dose at pre-specified dose levels. The primary purpose of the trial is to provide additional evidence of treatment effect and safety of palopegteriparatide at doses greater than 30 mcg/day in adults with hypoparathyroidism. The trial will be conducted in the US.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at consent
- Chronic hypoparathyroidism for at least 26 weeks (postsurgical, autoimmune, genetic, or idiopathic)
- Currently receiving palopegteriparatide doses of 30 micrograms/day or higher
- For those on 30 micrograms/day: evidence that this dose does not maintain normal serum calcium, including recent hypocalcemia or need for calcitriol or calcium supplements
- Laboratory confirmation within 2 weeks before randomization of vitamin D, magnesium, and calcium levels within specified ranges
- Body mass index between 17 and 40 kg/m2 at screening
- If 25 years or younger, X-ray showing closed growth plates in wrist and hand
- Estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 m2 or higher at screening
You will not qualify if you...
- Pseudohypoparathyroidism with elevated PTH and hypocalcemia
- Any other disease affecting calcium metabolism or parathyroid hormone levels besides hypoparathyroidism
- Use of certain medications including loop diuretics, phosphate binders (except calcium), digoxin, lithium, methotrexate, high-dose biotin, or systemic corticosteroids (except replacement therapy)
- Use of thiazide diuretics within 4 weeks before urine collection
- Use of PTH-like drugs other than palopegteriparatide within 4 weeks before screening
- Use of drugs influencing calcium and bone metabolism within 12 weeks before screening
- Use of osteoporosis treatments other than bisphosphonates within 2 years before screening
- Non-hypocalcemic seizure disorder with seizure in past 26 weeks
- Increased risk for osteosarcoma
- Pregnant or lactating women, or males with female partners who may become pregnant and unwilling to use contraception
- Drug or alcohol dependence diagnosed within 3 years before screening
- Severe or chronic heart disease within 26 weeks before screening
- Stroke within 5 years before screening
- Recent acute kidney stone colic or gout within 26 weeks before screening
- Participation in another investigational drug/device trial within 8 weeks before screening
- Known allergy or sensitivity to PTH or components of the study medication
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Ascendis Pharma Investigational Site
Reno, Nevada, United States, 89511
Actively Recruiting
2
Ascendis Pharma Investigational Site
New York, New York, United States, 10032
Actively Recruiting
3
Ascendis Pharma Investigational Site
Spokane Valley, Washington, United States, 99216
Actively Recruiting
Research Team
A
Ascendis Registry Inquiries
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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