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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06814145 | Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023) | PHASE2 | ACTIVE NOT_RECRUITING | 130 | — | — | Apr 16, 2025 | Aug 10, 2035 | Jun 8, 2026 | 57 | United States, Belgium +10 |
| NCT04945460 | A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16) | PHASE2 | COMPLETED | 164 | — | — | Dec 29, 2021 | Apr 9, 2026 | Apr 15, 2026 | 119 | United States, Belgium +10 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization (RHC).
| Arm | Type | Description |
|---|---|---|
| Sotatercept 0.3 mg/kg | EXPERIMENTAL | Participants receive sotatercept 0.3 mg/kg subcutaneous (SC) injection every 3 weeks (Q3W) for up to approximately 168 weeks or until discontinuation. |
| Sotatercept 0.7 mg/kg | EXPERIMENTAL | Participants receive sotatercept 0.7 mg/kg SC injection Q3W for up to approximately 168 weeks or until discontinuation. |
| Placebo | PLACEBO_COMPARATOR | Delivered subcutaneously (SC) every 3 weeks (Q3W) for 24 weeks in the placebo-controlled treatment period. |
| Sotatercept 0.3 mg/kg, escalating to 0.7 mg.kg | EXPERIMENTAL | Sotatercept SC at a starting dose level of 0.3 mg/kg for 3 dosing visits (Q3W), then escalating to 0.7 mg/kg SC on the fourth dosing visit and Q3W for the remainder of the 24-week treatment Period. |
| Name | Type | Description |
|---|---|---|
| Sotatercept | BIOLOGICAL | subcutaneous injection |
| Sotatercept 0.3 mg/kg | DRUG | Administered by subcutaneous injection. Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1. |
| Placebo | DRUG | Administered by subcutaneous injection |
| Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg | DRUG | Administered by subcutaneous injection. Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1. |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: \- Completed MK-7962-007 (CADENCE) (Visit 9 and end of treatment \[EOT\] visit) without discontinuing study intervention and is able to safely enroll into MK-7962-007 (HARMONIZE) Exclusion Criteria: The...