drugset / Trial / NCT07081997

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

NCT07081997 ↗

Phase 3 Recruiting 36 enrolled Ascendis Pharma Bone Diseases A/S
RandomizedParallel-groupOpen-labelTreatment

Summary

This trial has a duration of 78 weeks and will include adult participants already on treatment with palopegteriparatide at doses at or greater than 30 mcg/day. All participants will receive subcutaneous palopegteriparatide during the trial and will be individually and progressively titrated to an optimal dose at pre-specified dose levels. The primary purpose of the trial is to provide additional evidence of treatment effect and safety of palopegteriparatide at doses greater than 30 mcg/day in adults with hypoparathyroidism. The trial will be conducted in the US.

Timeline

Start
2026-04-16
Primary completion
2027-06
Completion
2028-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Palopegteriparatide Unknown 30 ug Subcutaneous

Indications