Actively Recruiting
Phase 3 Study of Daily Subcutaneous Palopegteriparatide at Doses Above 30 mcg in Adults with Hypoparathyroidism
Led by Ascendis Pharma Bone Diseases A/S · Updated on 2026-08-07
36
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial evaluates the safety and treatment effects of palopegteriparatide at doses above 30 mcgday in adults with hypoparathyroidism. It focuses on adults already receiving palopegteriparatide at doses of 30 mcgday or higher, aiming to provide more evidence about treatment impact and safety. The study is conducted in the United States and is a Phase 3 randomized clinical trial. Participants receive daily subcutaneous injections of palopegteriparatide, with dosing individually adjusted through either a novel or previously tested titration algorithm. All participants receive the active drug during the 78-week treatment period. The trial compares two dosing algorithms to find an optimal dose for each participant. Throughout the study, participants are monitored for efficacy primarily at 26 weeks and continue treatment for a total of 78 weeks. Assessments include laboratory tests to confirm vitamin D, magnesium, and calcium levels, as well as safety and tolerability evaluations. The trial aims to understand how well the drug works and its safety profile over this extended period.
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...
- Adults aged 18 years or older
- Diagnosed with chronic hypoparathyroidism for at least 26 weeks
- Receiving palopegteriparatide doses of 30 mcg/day or higher
- For those on 30 mcg/day, documented low calcium or need for calcitriol or calcium supplements
- Adequate vitamin D (≥20 ng/mL), magnesium, and calcium levels within 2 weeks before randomization
- Body mass index between 17 and 40 kg/m2
- If 25 years or younger, evidence of closed growth plates by X-ray
- Estimated glomerular filtration rate of at least 30 mL/min/1.73 m2 at screening
You will not qualify if you...
- Pseudohypoparathyroidism with PTH resistance
- Diseases affecting calcium or parathyroid hormone levels other than 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 other PTH-like drugs within 4 weeks before screening
- Use of drugs affecting calcium or bone metabolism within 12 weeks before screening
- Use of denosumab or romosozumab within 2 years or raloxifene within 4 weeks before screening
- Recent seizures or non-hypocalcemic seizure disorders within 26 weeks before screening
- Increased risk for osteosarcoma
- Pregnancy, intention to become pregnant, or breastfeeding
- Recent drug or alcohol dependence within 3 years
- Severe cardiac disease or recent stroke
- Recent acute kidney stone attacks or gout within 26 weeks
- Participation in other investigational drug trials within 8 weeks prior to screening
- Known allergy to PTH or components of the study drug
Research Team
A
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