A Phase 3 Randomized Clinical Trial to Investigate the Safety and Efficacy of Palopegterip
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-sp
| Condition(s) | Hypoparathyroidism, Endocrine System Diseases, Parathyroid Diseases |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion criteria: 1. Males and females, ≥18 years of age at the time of providing informed consent 2. Participants with postsurgical chronic hypoparathyroidism (HP), or auto-immune, genetic, or idiopathic HP, for at least 26 weeks 3. Receiving doses of palopegteriparatide at or above 30 µg/day For individuals receiving 30 µg/day: evidence that dose is insufficient to keep serum calcium in the normal range, defined as: Documented hypocalcemia within 12 weeks prior to Screening; and/or Standing dose of calcitriol ≥0.25 μg/day, and / or (elemental) calcium ≥1500 mg/day (e.g., calcium citrate, calcium carbonate etc.) for at least 4 weeks prior to Screening For individuals receiving 33 µg/day or greater: no requirement for documented hypocalcemia or minimum doses of calcitriol or elemental ca |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Ascendis Pharma Bone Diseases A/S |
| Locations | Reno, Nevada, United States; New York, New York, United States; Spokane Valley, Washington, United States |
| Start date | 2026-04-16 |
| NCT ID | NCT07081997 |
| Official listing | https://clinicaltrials.gov/study/NCT07081997 |