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...
QCZ484 is an investigational small molecule being developed for hypertension and related conditions. It is being studied in patients with mild to moderate hypertension, as well as in combination with inclisiran for hypertension with concomitant hypercholesterolemia. The drug is currently in Phase 2 clinical development.
QCZ484 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials of QCZ484 in multiple countries including the United States, Japan, Singapore, Australia, and New Zealand.
QCZ484 is currently in Phase 2 clinical development for hypertension. The company has completed a Phase 1 safety study and is conducting multiple Phase 2 trials, including a dose-finding study, an open-label extension study, and a combination study with inclisiran. QCZ484 remains investigational and is not yet approved by regulatory authorities.
QCZ484 is being evaluated in several clinical trials. NCT06857955 is a Phase 2 dose-finding study in mild to moderate hypertensive patients. NCT07543120 is an open-label extension study in hypertensive patients. NCT07610278 is a Phase 2 study combining QCZ484 with inclisiran in patients with hypertension and hypercholesterolemia. A Phase 1 safety study, NCT06905327, has been completed.
Yes, QCZ484 is being studied in combination with inclisiran. Clinical trial NCT07610278 is evaluating the pharmacodynamics of a combination of QCZ484 and inclisiran in participants with hypertension and concomitant hypercholesterolemia. This Phase 2 study is currently recruiting participants in the United States.
No, QCZ484 is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for hypertension. The drug is being studied in active clinical trials but has not yet received regulatory approval for any indication.