Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE3 | RECRUITING | 36 | — | — | Apr 16, 2026 | Jun 1, 2028 | May 4, 2026 | 3 | United States |
The proportion of participants with: Albumin-adjusted serum calcium (sCa) measured within 4 weeks prior to and on the Week 26 visit within the normal range (8.3-10.6 mg/dL); and independence from active vitamin D; and independence from therapeutic doses of calcium; and no increase in prescribed investigational product within 4 weeks prior to Week 26 visit.
| Arm | Type | Description |
|---|---|---|
| Palopegteriparatide Experimental Arm | EXPERIMENTAL | Palopegteriparatide at doses at or greater than 30 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose by a novel titration algorithm. |
| Palopegteriparatide Control Arm | ACTIVE_COMPARATOR | Palopegteriparatide at doses at or greater than 30 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose by a previously evaluated titrated algorithm |
| Name | Type | Description |
|---|---|---|
| Palopegteriparatide Experimental Arm | COMBINATION_PRODUCT | Palopegteriparatide is supplied as a solution with a concentration of 0.3 mg/mL in a single-patient-use prefilled pen intended for subcutaneous injection. |
| Palopegteriparatide Control Arm | COMBINATION_PRODUCT | Palopegteriparatide is supplied as a solution with a concentration of 0.3 mg/mL in a single-patient-use prefilled pen intended for subcutaneous injection. |
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 ...