A Phase 3, Multicenter, Open-Label Single-Arm Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Palopegteriparatide Administered Subcutaneously Daily in the Adolescent Population (12 Years to Less Than 18 Years of Age) With Chronic Hypoparathyroidism
This trial will enroll adolescents between ages of ≥12 and \<18 years with clinically diagnosed hypoparathyroidism . The purpose of the study is to see how well treatment with once-daily palopegteriparatide works and how safe it is. At least 12 participants will receive palopegteriparatide for 234 weeks. This trial will be conducted in Europe.
• 1\. Males and females, 12 to less than 18 years of age
• 2\. Participants with postsurgical chronic hypoparathyroidism, or auto-immune, genetic, or idiopathic hypoparathyroidism for at least 26 weeks
• 3\. Normal levels of serum 25(OH) vitamin D and magnesium
• 4\. Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73
• 5\. Able to perform daily subcutaneous self-injections of palopegteriparatide (or have a caregiver to perform injections)
• 6\. Body mass index (BMI) Z-score greater than -2 SDS and below + 3 SDS
• 7\. Written, signed informed consent