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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05353166 | REGN5381 in Heart Failure Adult Participants With Elevated Pulmonary Capillary Wedge Pressure | PHASE2 | COMPLETED | 59 | — | — | Jun 30, 2022 | Jun 2, 2025 | Jun 11, 2025 | 1 | Moldova |
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Randomized 1:1; limited to participants with heart failure with reduced ejection fraction (HFrEF) not taking sacubitril/valsartan |
| Group B | EXPERIMENTAL | Randomized 1:1; limited to participants with HFrEF taking sacubitril/valsartan |
| Group C | EXPERIMENTAL | Randomized 1:1; limited to participants with heart failure with preserved ejection fraction (HFpEF) not taking sacubitril/valsartan |
| Name | Type | Description |
|---|---|---|
| REGN5381 | DRUG | Single dose administered via IV infusion |
| Matching Placebo | DRUG | Single dose administered via IV infusion |
Key Inclusion Criteria: 1. Body mass index (BMI) between 18 and 35 kg/m\^2, inclusive, rounded to the nearest whole number 2. Ambulatory participants with New York Heart Association (NYHA) class II/III heart failure and at least 1 sign and/or symptom of congestion (eg, dyspnea on exertion, worsenin...