Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
QCZ484 · 4 trials · 4 indications
Percent (%) change from baseline of PCSK9 levels for QCZ484 + Inclisiran at Month 3
Percent (%) change from baseline of AGT levels for QCZ484 + Inclisiran at Month 3
Number of participants with Adverse events (AEs), including abnormal safety laboratory parameters and vital signs
Change from baseline at Month 3 in mean 24hr systolic blood pressure (SBP) by ambulatory blood pressure measurement (ABPM)
Overall number of AEs, severity, and relationship to study treatment per treatment group.
Safety laboratory data (blood chemistry, hematology, coagulation, and urinalysis)
| Arm | Type | Description |
|---|---|---|
| QCZ484 + Inclisiran | EXPERIMENTAL | QCZ484 + inclisiran, once on Day 1 |
| QCZ484 | ACTIVE_COMPARATOR | QCZ484 + inclisiran placebo, once on Day 1 |
| Inclisiran | ACTIVE_COMPARATOR | Inclisiran + QCZ484 placebo, once on Day 1 |
| Placebo | PLACEBO_COMPARATOR | QCZ484 placebo + inclisiran placebo, once on Day 1 |
| Placebo Control | PLACEBO_COMPARATOR | Placebo |
| QCZ484 Dose 1 | EXPERIMENTAL | QCZ484 Dose 1 solution for injection |
| QCZ484 Dose 2 | EXPERIMENTAL | QCZ484 Dose 2 solution for injection |
| QCZ484 Dose 3 | EXPERIMENTAL | QCZ484 Dose 3 solution for injection |
| QCZ484 Dose 4 | EXPERIMENTAL | QCZ484 Dose 4 solution for injection |
| QCZ484 Dose 5 | EXPERIMENTAL | QCZ484 Dose 5 solution for injection |
| Part A: QCZ484 50 mg | EXPERIMENTAL | Healthy Cohort: single dose |
| Part A: QCZ484 150 mg | EXPERIMENTAL | Healthy Cohort: single dose |
| Part A: QCZ484 300 mg | EXPERIMENTAL | Healthy Cohort: single dose |
| Part A: QCZ484 600 mg | EXPERIMENTAL | Healthy Cohort: single dose |
| Part A: QCZ484 Placebo | PLACEBO_COMPARATOR | Healthy Cohort: single dose |
| Part B: QCZ484 150 mg | EXPERIMENTAL | Hypertension Cohort: single dose |
| Part B: QCZ484 300 mg | EXPERIMENTAL | Hypertension Cohort: single dose |
| Part B: QCZ484 600 mg | EXPERIMENTAL | Hypertension Cohort: single dose |
| Part B: QCZ484 Placebo | PLACEBO_COMPARATOR | Hypertension Cohort: single dose |
| Name | Type | Description |
|---|---|---|
| QCZ484 | DRUG | QCZ484 once on Day 1 |
| Inclisiran | DRUG | Inclisiran once on Day 1 |
| QCZ484 placebo | DRUG | QCZ484 placebo once on Day 1 |
| Inclisiran placebo | DRUG | Inclisiran placebo once on Day 1 |
| Saline | OTHER | 0.9% sodium chloride saline solution |
| Placebo | DRUG | via subcutaneous injection |
Inclusion Criteria: * Males or females aged 18 to 75 years. * Diagnosis of primary hypertension. * Treatment with either no, or up to 2 antihypertensive medications at a stable dose for at least 4 weeks preceding screening. * Systolic blood pressure ≥140 and \<165 mmHg based on the mean of 3 sittin...