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 developed by Novartis AG for metabolic conditions, specifically hypercholesterolaemia and hypertension, including mild hypertension. It is being studied in Phase 2 clinical development, with trials enrolling adults with these cardiovascular and metabolic conditions.
QCZ484 is being developed for hypercholesterolaemia and hypertension, including mild hypertension. Clinical trials are evaluating it in adults with hypertension and concomitant hypercholesterolemia, as well as in hypertensive patients more broadly. It is an investigational therapy and has not been approved for any indication.
QCZ484 is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program evaluating QCZ484 in hypertension and hypercholesterolaemia.
QCZ484 is in Phase 2 clinical development. Two Phase 2 trials are currently recruiting, and one additional Phase 2 trial is active but not recruiting. A Phase 1 safety study in healthy and mild hypertensive subjects has been completed. QCZ484 is investigational and has not been approved by the FDA.
QCZ484 is being studied in several trials. NCT07610278 is a Phase 2 study of QCZ484 combined with inclisiran in hypertension with concomitant hypercholesterolemia. NCT07543120 is an open-label Phase 2 extension study in hypertensive patients. NCT06857955 is a Phase 2 dose-finding study, and NCT06905327 is a completed Phase 1 safety study.
Across the QCZ484 clinical program, total enrollment is 719 participants. The trials include a Phase 1 study of 56 subjects, a Phase 2 dose-identification study of 396 patients, a Phase 2 combination study of 120 participants, and a Phase 2 open-label extension study of 323 patients.