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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07037420 | ALXN2420 Versus Placebo in Combination With Somatostatin Analogs in Participants With Acromegaly | PHASE2 | RECRUITING | 60 | — | — | Oct 28, 2025 | Nov 11, 2027 | Apr 7, 2026 | 45 | United States, Argentina +9 |
| Arm | Type | Description |
|---|---|---|
| ALXN2420 | EXPERIMENTAL | During the Primary Evaluation Period, participants will receive the first dose of ALXN2420 via SC injection on Day 1, followed by daily administration thereafter for a total of 15 weeks. |
| Placebo | PLACEBO_COMPARATOR | During the Primary Evaluation Period, participants will receive the first dose of placebo via SC injection on Day 1, followed by daily administration thereafter for a total of 15 weeks. |
| Open-label Extension Period | EXPERIMENTAL | During the Open-label Extension (OLE) Period, participants in the ALXN2420 treatment groups will continue receiving ALXN2420 treatment and participants in the placebo groups will crossover to receive ALXN2420 at Week 15. At the Week 15 Visit, the dose level and the dosing regimen of ALXN2420 will be determined for each participant based on the Week 13 IGF-1 level. The OLE Period assessments will be performed at Weeks 19, 26, 32, 39, 45, and 52. |
| Name | Type | Description |
|---|---|---|
| ALXN2420 | DRUG | ALXN2420 will be administered via subcutaneous (SC) injection |
| Placebo | DRUG | Placebo will be administered via SC injection. |
Inclusion Criteria: * Documented diagnosis of acromegaly, that is, historically documented evidence of a GH-secreting pituitary adenoma based on MRI or pathology report * Must be receiving maximum, or maximally tolerated dose per treating physician judgment, of long-acting SSAs (octreotide or lanre...