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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05612035 | Frespaciguat (MK-5475) INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of Frespaciguat (an Inhaled sGC Stimulator) in Adults With PH-COPD | PHASE2 | ACTIVE NOT_RECRUITING | 129 | — | — | Mar 16, 2023 | Oct 8, 2029 | May 1, 2026 | 85 | United States, Argentina +17 |
| NCT04370873 | Frespaciguat (MK-5475) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD) (MK-5475-006) | PHASE1 | COMPLETED | 22 | — | — | Jun 5, 2020 | Jan 12, 2022 | May 28, 2025 | 9 | United States, Israel +1 |
6MWD is assessed using the 6-minute walk test (6MWT).
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE was assessed.
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued treatment due to an AE was assessed.
PVR was calculated in participants after MK-5475 dosing at baseline and Day 28. Based on the variables obtained by right heart catheterization (RHC), the fold change from baseline individual PVR was calculated. The difference from baseline was assessed on the log scale and then back-transformed for reporting (percent change from baseline). Per protocol, this outcome measure was only assessed during the Part 2 and was not assessed during part 1.
| Arm | Type | Description |
|---|---|---|
| Frespaciguat | EXPERIMENTAL | Participants with PH-COPD will receive 380 µg of frespaciguat as an oral inhalation once daily for 24 weeks (base period) and thereafter for up to 42 months (optional extension period). |
| Placebo | PLACEBO_COMPARATOR | Participants with PH-COPD will receive matching placebo as an oral inhalation once daily for 24 weeks (base period) and then 380 µg of frespaciguat as an oral inhalation once daily for up to 42 months (optional extension period). |
| Part 1: Frespaciguat | EXPERIMENTAL | Participants receive frespaciguat 360 μg once daily (QD) via inhalation from Days 1-7. Following review of pharmacokinetic (PK) and safety data, a second 7 days of dosing may be initiated. A dose of up to 360 μg up to twice a day may be administered based on PK data in these participants. |
| Part 1: Placebo | PLACEBO_COMPARATOR | Participants receive placebo QD via inhalation from Days 1-7. |
| Part 2: Frespaciguat | EXPERIMENTAL | Participants receive frespaciguat 32 µg, 100 µg, 195 µg or 380 μg QD via inhalation from Days 1-28. |
| Part 2: Placebo | PLACEBO_COMPARATOR | Participants receive placebo QD via inhalation from Days 1-28. |
| Name | Type | Description |
|---|---|---|
| Frespaciguat | DRUG | Frespaciguat 380 µg administered as dry powder inhalation once daily. |
| Placebo | DRUG | Placebo administered as dry powder inhalation once daily. |
The key inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Has Group 3.1 pulmonary hypertension chronic obstructive pulmonary disease (PH-COPD) as defined by the Clinical Classification of Pulmonary Hypertension. * Has a right heart catheterization...