A Study to Identify an Optimal Dose of QCZ484 in Mild to Moderate Hypertensive Patients

Phase 2

Recruiting

• Conditions: Hypertension
• Interventions: Other: Saline; Drug: QCZ484

• Registration Number: NCT06857955
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of QCZ484 or placebo, given subcutaneously, every 6 months, at different dose levels in patients with mild to moderate hypertension

Detailed Description

Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and pharmacodynamics of QCZ484 with mild to moderate hypertension (HTN). Multiple doses of QCZ484 will be tested against placebo, administered as subcutaneous injection.

Study Timeline

• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-03
• Study First Posted: 2025-03-05
• Study Start: 2025-03-26
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-07
• Last Update Posted: 2025-08-13
• Primary Completion: 2026-12-31
• Study Completion: 2028-04-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

1. Signed informed consent.
2. Males or females aged 18 to 75 years.
3. Diagnosis of hypertension.
4. Hypertension treatment naive or on maximum 2 anti-HTN medications and able to undergo washout for 4 weeks.
5. Mean sitting SBP ≥140 mmHg measured by OBPM and mean 24 hr SBP ≥130 mmHg and <160 mmHg measured by ABPM.
6. Participants able to understand and comply with study procedures.

Exclusion Criteria

1. Known history of secondary hypertension.
2. Orthostatic hypotension.
3. Laboratory parameter assessments outside of range at screening.
4. Evidence of hepatic disease.
5. Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.
6. Any history of congestive heart failure.
7. Current or history of intolerance to ACEi and/or ARBs.
8. Clinically significant cardiac arrhythmias, high-grade AV block and third-degree AV block within 6 months prior to screening.
9. Acute myocardial infarction (AMI) or unstable angina, or any percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within 12 months prior to screening. Any history of ischemic or hemorrhagic stroke or transient ischemic attack any time prior to screening.

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Control	Saline	Placebo
QCZ484 Dose 1	QCZ484	QCZ484 Dose 1 solution for injection
QCZ484 Dose 2	QCZ484	QCZ484 Dose 2 solution for injection
QCZ484 Dose 3	QCZ484	QCZ484 Dose 3 solution for injection
QCZ484 Dose 4	QCZ484	QCZ484 Dose 4 solution for injection
QCZ484 Dose 5	QCZ484	QCZ484 Dose 5 solution for injection

Primary Outcome Measures

Name	Time	Method
Change in Mean 24hr SBP by ABPM	Baseline, Month 3	Change from baseline at Month 3 in mean 24hr systolic blood pressure (SBP) by ambulatory blood pressure measurement (ABPM)

Secondary Outcome Measures

Name	Time	Method
Change in Mean 24hr SBP by ABPM	Baseline, Month 6	Change from baseline at Month 6 in mean 24hr SBP by ABPM
Change in SBP by OBPM	Baseline, Month 3 and 6	Change from baseline at Month 3 and 6 in SBP by office blood pressure measurement (OBPM)
Change in DBP by ABPM and OBPM	Baseline, Month 3 and 6	Change from baseline at Month 3 and 6 on diastolic blood pressure (DBP) by ABPM and OBPM
Participants achieving SBP<130 mmHg or SBP reduced by ≥10 mmHg by ABPM	Baseline, Month 3 and 6	Proportion of responders defined as participants achieving SBP\<130 mmHg or SBP reduced by ≥10 mmHg from baseline, at Month 3 and 6 by ABPM
Number of participants with AEs	Up to Month 18	Number of participants with AEs by treatment group, including changes in vital signs and laboratory results qualifying and reported as AEs.

Trial Locations

Locations (44)

SEC Clinical Research LLC; 🇺🇸 Andalusia, Alabama, United States

Synexus Clinical Research US Inc; 🇺🇸 Richfield, Minnesota, United States

NICRs Research Center; 🇺🇸 Garden Grove, California, United States

Downtown L.A. Research Center Inc; 🇺🇸 Los Angeles, California, United States

Clinical Trials Research Sacramento; 🇺🇸 Sacramento, California, United States

Encompass Clinical Research; 🇺🇸 Spring Valley, California, United States

Clinical Research of Brandon LLC; 🇺🇸 Brandon, Florida, United States

ALL Medical Research LLC; 🇺🇸 Cooper City, Florida, United States

Cen Exel RCA; 🇺🇸 Hollywood, Florida, United States

East Coast Institute for Research; 🇺🇸 Jacksonville, Florida, United States

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