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
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
Research Team
A
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