Daily Palopegteriparatide Injections for Adolescents Aged 12 to Under 18 With Long-Term Hypoparathyroidism A Phase 3 Treatment Study

What this Trial Is About

Researchers are evaluating the effects and safety of once-daily palopegteriparatide injections in adolescents aged 12 to under 18 years who have long-term hypoparathyroidism. The study focuses on participants with clinically diagnosed hypoparathyroidism lasting at least 26 weeks and aims to understand how well this treatment works and its safety profile over a long period. Participants will receive palopegteriparatide by subcutaneous injection once daily for up to 234 weeks. During this time, researchers will monitor various health aspects including serum biochemistries, bone mineral density, renal calcifications, hospital visits, adverse events, and patient-reported symptom and impact scores. This is a single-group Phase 3 trial conducted in Europe. Participants will be involved in regular assessments throughout the study, including blood and urine tests, imaging for kidney calcifications, bone health evaluations, and symptom questionnaires. The main outcome is the percentage of participants achieving a specific efficacy endpoint at 26 weeks, with ongoing monitoring continuing through the full 234 weeks. Safety and treatment effects will be closely observed during the entire study period.

A Study to Test the Effects and Safety of Palopegteriparatide in Adolescents With Long-term Hypoparathyroidism