Actively Recruiting
A Phase 3, Multicenter, Randomized, Open-Label Trial Investigating the Safety, Tolerability and Efficacy of Palopegteriparatide Administered Subcutaneously Daily at Doses Greater Than 30 mcg/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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of palopegteriparatide at doses greater than 30 mcg per day in adults with hypoparathyroidism. This phase 3 trial focuses on adults who have been living with chronic hypoparathyroidism for at least 26 weeks and are already receiving treatment with palopegteriparatide at doses of 30 mcg/day or higher. The study aims to provide more evidence on the treatment effects and safety of higher doses of this medication. Participants will receive subcutaneous injections of palopegteriparatide once daily, with doses starting at or above 30 mcg. They will be randomly assigned to one of two groups using different dose titration algorithms to find an optimal dose. Both groups receive the same medication delivered by a prefilled pen designed for single-patient use. The treatment period lasts for 78 weeks, during which the dose may be progressively adjusted based on individual needs. Throughout the study, participants will have regular visits to monitor safety and treatment effects, including laboratory tests to check calcium levels and other relevant biomarkers. The primary outcome focuses on treatment efficacy measured after 26 weeks. The trial includes ongoing monitoring of laboratory parameters and safety assessments, with participation lasting up to 78 weeks in total. This helps researchers better understand how the medication works at higher doses in adults with hypoparathyroidism.
CONDITIONS
Brief 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...
- Males and females aged 18 years or older at the time of informed consent
- Diagnosis of postsurgical, autoimmune, genetic, or idiopathic chronic hypoparathyroidism for at least 26 weeks
- Currently receiving palopegteriparatide at doses of 30 mcg/day or higher
- For those on 30 mcg/day: documented hypocalcemia within 12 weeks prior to screening or stable use of calcitriol or elemental calcium for at least 4 weeks before screening
- For those on 33 mcg/day or higher: no requirement for documented hypocalcemia or minimum doses of calcitriol or calcium
- Laboratory confirmation within 2 weeks before randomization with vitamin D levels 20-80 ng/mL and magnesium levels at or just below normal
- Albumin-adjusted or ionized serum calcium levels in or just below the normal range
- Body mass index between 17 and 40 kg/m2 at screening
- If 25 years or younger, radiological evidence of bone growth plate closure
- Estimated glomerular filtration rate of 30 mL/min/1.73 m2 or higher at screening
You will not qualify if you...
- Pseudohypoparathyroidism or other diseases affecting calcium metabolism aside from hypoparathyroidism
- Use of loop diuretics, phosphate binders (except calcium supplements), digoxin, lithium, methotrexate, high-dose biotin, or systemic corticosteroids other than replacement therapy
- Use of thiazide diuretics within 4 weeks prior to urine collection
- Use of PTH-like drugs other than palopegteriparatide within 4 weeks prior to screening
- Use of drugs influencing calcium and bone metabolism within 12 weeks prior to screening
- Use of osteoporosis therapies other than bisphosphonates within 2 years prior to screening
- Non-hypocalcemic seizure disorder with seizures within 26 weeks prior to screening
- Increased risk for osteosarcoma
- Women who are pregnant, breastfeeding, or planning pregnancy
- Males with female partners of childbearing potential unwilling to use contraception
- Diagnosed drug or alcohol dependence within 3 years prior to screening
- Severe or chronic heart disease within 26 weeks prior to screening
- Stroke within 5 years prior to screening
- Recent acute kidney stone colic or gout within 26 weeks prior to screening
- Participation in other interventional trials with investigational drugs (other than palopegteriparatide) within 8 weeks prior to screening
- Known allergy or sensitivity to PTH or any components of the study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 26 weeks
Participants receive daily subcutaneous injections of palopegteriparatide at doses of 30 mcg or higher, titrated to an optimal dose by a titration algorithm.
Weekly visits during treatment
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
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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