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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05778071 | Evaluation of the Safety and Efficacy of Eneboparatide (AZP-3601) in Patients With Chronic Hypoparathyroidism | PHASE3 | ACTIVE NOT_RECRUITING | 165 | — | — | Jun 7, 2023 | Jun 16, 2027 | Sep 29, 2025 | 54 | United States, Canada +11 |
After 24 weeks of treatment, the proportion of patients in the eneboparatide treatment group vs. placebo: * Achieving complete independence from active vitamin D; * Achieving independence from therapeutic doses of oral calcium (i.e. taking oral elemental calcium supplements ≤600 mg/day); and * With albumin-adjusted serum calcium within the normal range (8.3 to 10.6 mg/dL).
| Arm | Type | Description |
|---|---|---|
| eneboparatide | EXPERIMENTAL | Starting dose of 20 mcg; Administered once daily by subcutaneous injection |
| Placebo | PLACEBO_COMPARATOR | Administered once daily by subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| eneboparatide | COMBINATION_PRODUCT | Supplied as a solution (concentration of 250 mcg/mL or 500 mcg/mL) in single-patient-use prefilled pens |
| Placebo | COMBINATION_PRODUCT | Placebo is supplied as a solution (containing the excipient solution for eneboparatide) in single-patient-use prefilled pens |
Inclusion Criteria: 1. Males and Females, 18-80 years of age 2. Patients with cHP for ≥12 months at the time of screening 3. Two paired measurements of showing low parathyroid hormone (PTH) and serum calcium either below normal or within normal under standard of care 4. Requirement for therapy with...