QCZ484 for High Blood Pressure

Recruiting at 51 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Must not be taking: RAAS inhibitors, ACEi, ARBs

Disqualifiers: Secondary hypertension, Hepatic disease, CHF, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

380 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, QCZ484, for individuals with mild to moderate high blood pressure. Researchers aim to determine the effectiveness and safety of this treatment when administered as an injection every six months. Participants will receive either varying doses of the treatment or a placebo (a harmless substance with no therapeutic effect) for comparison. This trial may suit those diagnosed with high blood pressure who have either never been treated or are on up to two medications and can pause them temporarily. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

If you are currently on up to two blood pressure medications, you will need to stop taking them for a 4-week period before starting the trial.

Is there any evidence suggesting that QCZ484 is likely to be safe for humans?

Research has shown that QCZ484 has undergone safety testing in previous studies. In these studies, researchers administered different doses to both healthy individuals and those with mild high blood pressure. The results indicated that QCZ484 was generally well-tolerated, with most participants not experiencing serious side effects.

However, the treatment remains in a phase where safety is closely monitored. This phase suggests that while the treatment has shown promise in early tests, further safety checks are necessary. So far, the data has not revealed any serious or unexpected side effects, which is reassuring.

For those considering joining the trial, understanding this safety background can aid in making an informed decision. Always consult a healthcare provider to determine if this trial is suitable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for high blood pressure?

Researchers are excited about QCZ484 for high blood pressure because it introduces a potential new mechanism of action compared to traditional treatments like ACE inhibitors or beta-blockers. Unlike these standard therapies, QCZ484 is delivered as a solution for injection, which might offer faster absorption and more precise dosing. This could be particularly beneficial for patients who struggle with oral medications or need rapid blood pressure control. Overall, QCZ484's novel approach and delivery method have the potential to provide an alternative option for managing high blood pressure more effectively.

What evidence suggests that QCZ484 might be an effective treatment for high blood pressure?

Research has shown that QCZ484 might help lower high blood pressure. In earlier studies, QCZ484 reduced blood pressure in people with mild to moderate hypertension. In this trial, participants will receive different doses of QCZ484 or a placebo. The treatment is administered as an injection every six months, offering convenience for those who prefer not to take daily medication. While exact results from past studies aren't provided, early findings suggest that QCZ484 could be a promising long-term method for managing blood pressure. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with mild to moderate high blood pressure, either untreated or on up to two medications (which they can stop for 4 weeks). They need a specific range of blood pressure readings and must be able to understand and follow the study's procedures after giving informed consent.

Inclusion Criteria

I have signed the informed consent form.

My average blood pressure is high, both when sitting and over 24 hours.

I have high blood pressure and take no more than 2 medications for it, and can stop these medications for 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive QCZ484 or placebo subcutaneously every 6 months at different dose levels

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• QCZ484

Trial Overview The trial is testing QCZ484, a new medication given by injection every six months, against saline (a placebo). It aims to find the best dose by looking at how well it works and its safety in lowering blood pressure over time.

How Is the Trial Designed?

Group I: QCZ484 Dose 5 Experimental Treatment 1 Intervention

QCZ484 Dose 5 solution for injection

Group II: QCZ484 Dose 4 Experimental Treatment 1 Intervention

QCZ484 Dose 4 solution for injection

Group III: QCZ484 Dose 3 Experimental Treatment 1 Intervention

QCZ484 Dose 3 solution for injection

Group IV: QCZ484 Dose 2 Experimental Treatment 1 Intervention

QCZ484 Dose 2 solution for injection

Group V: QCZ484 Dose 1 Experimental Treatment 1 Intervention

QCZ484 Dose 1 solution for injection

Group VI: Placebo Control Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06905327

NCT06905327 | A Study to Evaluate the Safety of QCZ484 ... This is a randomized, double-blind, placebo-controlled study including Part A single ascending dose (SAD) in healthy subjects and Part B single dose in subjects ...

2. novartis.com novartis.com/clinicaltrials/study/nct06857955

A Study to Identify an Optimal Dose of QCZ484 in Mild ... 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 ...

3. bereflected.org bereflected.org/clinical-trials/listings/340302/a-study-to-identify/

A Study to Identify an Optimal Dose of QCZ484 in Mild ... This study aims to find the best dose of a new medicine, QCZ484, for people with mild to moderate high blood pressure (hypertension).

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06857955

NCT06857955 | A Study to Identify an Optimal Dose of ... 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 ...

5. withpower.com withpower.com/trial/qcz484-for-high-blood-pressure-52846

QCZ484 for High Blood Pressure 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 ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-to-identify-an-optimal-dose-of-qcz484-in-mild-to-moderate-hypertensive-patients

A Study to Identify an Optimal Dose of QCZ484 in Mild to ... The purpose of this study is to evaluate the efficacy, safety and tolerability of QCZ484 or placebo, given subcutaneously, every 6 months, ...

7. trial.medpath.com trial.medpath.com/clinical-trial/ca62d7cc2c0ebbf9/nct06905327-qcz484-safety-tolerability-hypertension

A Study to Evaluate the Safety of QCZ484 in Healthy and Mild ... Mean sitting systolic blood pressure (SBP) of >=130 and <160 mm Hg ... Safety laboratory data (blood chemistry, hematology, coagulation, and urinalysis).