A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia

July 29, 2026 updated by: Novartis Pharmaceuticals

A Multicenter, Randomized, Double-blind, Factorial Design Phase 2 Study to Evaluate the Pharmacodynamics, Safety and Tolerability of HDY015 Administered as a Free Combination of QCZ484 and Inclisiran Compared to QCZ484, Inclisiran, and Placebo in Participants With Hypertension and Concomitant Hypercholesterolemia

This is a multicenter, randomized, double-blind, factorial design Phase 2 study to evaluate the pharmacodynamics, safety and tolerability of a combination of QCZ484 and inclisiran compared to QCZ484, inclisiran, and placebo in participants with hypertension and concomitant hypercholesterolemia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will last up to 12 months and has three periods:

  • Eligibility will be assessed during the screening period including 2 screening visits. Some eligibility criteria will be confirmed at the Baseline/Randomization visit.
  • Eligible participants will be randomized to receive a combination of QCZ484 and inclisiran, QCZ484, inclisiran or placebo once on Day 1 at the Baseline/Randomization visit.
  • Afterwards, participants will enter the safety follow-up period. Eligible participants who complete the treatment period have the option to participate in an open-label extension study instead of entering the safety follow-up period.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals

Study Locations

  • United States
    • Alabama
      • Foley, Alabama, United States, 36535
        • Recruiting
        • G and L Research LLC
        • Principal Investigator:
          • Nidal Morrar
        • Contact:
      • Saraland, Alabama, United States, 36571
    • California
      • Lincoln, California, United States, 95648
        • Recruiting
        • Clinical Trials Research
        • Principal Investigator:
          • Jeffrey D Wayne
        • Contact:
      • Los Angeles, California, United States, 90017
        • Recruiting
        • Downtown L A Research Center Inc
        • Contact:
        • Principal Investigator:
          • Salil U Nadkarni
      • Northridge, California, United States, 91325
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Recruiting
        • Flourish Medical Clinical Trials
        • Principal Investigator:
          • Rasha Youssef
        • Contact:
      • Brandon, Florida, United States, 33511
        • Recruiting
        • Clinical Research of Brandon LLC
        • Principal Investigator:
          • German Alvarez
        • Contact:
      • Cooper City, Florida, United States, 33024
        • Recruiting
        • ALL Medical Research LLC
        • Principal Investigator:
          • Lorena Lewy-Alterbaum
        • Contact:
      • Coral Gables, Florida, United States, 33134
      • Doral, Florida, United States, 33166
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • East Coast Institute for Research
        • Principal Investigator:
          • Minesh Patel
        • Contact:
      • Miami, Florida, United States, 33176
      • Miami Lakes, Florida, United States, 33014
      • Pembroke Pines, Florida, United States, 33027
      • Saint Augustine, Florida, United States, 32086
        • Recruiting
        • East Coast Inst for Research LLC
        • Principal Investigator:
          • Ferris George
        • Contact:
    • Georgia
      • Canton, Georgia, United States, 30114
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Recruiting
        • Great Lakes Clinical Trials
        • Principal Investigator:
          • Manish Jain
        • Contact:
      • Niles, Illinois, United States, 60714
    • Kansas
      • Wichita, Kansas, United States, 67207
    • Louisiana
      • West Monroe, Louisiana, United States, 71291
    • Maryland
      • Ft. Washington, Maryland, United States, 20744
      • Lanham, Maryland, United States, 20706
        • Recruiting
        • Capitol Cardiology Associates
        • Principal Investigator:
          • Vineet Venugopal
        • Contact:
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Recruiting
        • Monroe Biomedical Research
        • Principal Investigator:
          • Awawu Igbinadolor
        • Contact:
    • South Carolina
      • Little River, South Carolina, United States, 29566
        • Recruiting
        • Walker Family Care
        • Principal Investigator:
          • Stephen D Grubb
        • Contact:
    • Texas
      • Houston, Texas, United States, 77061
        • Recruiting
        • Synergy Group Medical LLC
        • Principal Investigator:
          • Caroline N Mbogua
        • Contact:
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Recruiting
        • Manassas Clinical Research Center
        • Principal Investigator:
          • Nabil Andrawis
        • Contact:
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • Dominion Medical Associates
        • Principal Investigator:
          • Richard A Jackson
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 sitting measurements based on office blood pressure monitoring.
  • Diagnosis of hypercholesterolemia including heterozygous familial hypercholesterolemia unable to reach LDL-C goals with a stable dose of statin treatment for at least 4 weeks prior to screening as per Investigator judgement, guidelines and local practice (if tolerated and not contraindicated) with or without bempedoic acid and with or without ezetimibe prescribed according to local guidance, at a stable dose for at least 4 weeks preceding Screening Visit 1.

The following parameters must be confirmed at Screening Visit 2:

  • Fasting serum LDL-C ≥70 mg/dL and <190 mg/dL using Friedewald equation.
  • Fasting triglyceride <400 mg/dL.

Exclusion Criteria:

  • Symptomatic orthostatic hypotension.
  • Treatment with certain medications and/or unable to comply with prohibited medications requirements.

Other protocol inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QCZ484 + Inclisiran
QCZ484 + inclisiran, once on Day 1
Drug: QCZ484
QCZ484 once on Day 1
Drug: Inclisiran
Inclisiran once on Day 1
Other Names:
  • KJX839
  • Leqvio
Active Comparator: QCZ484
QCZ484 + inclisiran placebo, once on Day 1
Drug: QCZ484
QCZ484 once on Day 1
Active Comparator: Inclisiran
Inclisiran + QCZ484 placebo, once on Day 1
Drug: Inclisiran
Inclisiran once on Day 1
Other Names:
  • KJX839
  • Leqvio
Placebo Comparator: Placebo
QCZ484 placebo + inclisiran placebo, once on Day 1
Drug: QCZ484 placebo
QCZ484 placebo once on Day 1
Drug: Inclisiran placebo
Inclisiran placebo once on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change from baseline of PCSK9 levels
Time Frame: Baseline and Month 3
Percent (%) change from baseline of PCSK9 levels for QCZ484 + Inclisiran at Month 3
Baseline and Month 3
Percent change from baseline of AGT levels
Time Frame: Baseline and Month 3
Percent (%) change from baseline of AGT levels for QCZ484 + Inclisiran at Month 3
Baseline and Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of systolic blood pressure
Time Frame: Baseline, Month 3 and Month 6
Change from baseline of systolic blood pressure for QCZ484 + Inclisiran at Month 3 and 6.
Baseline, Month 3 and Month 6
Change from baseline of LDL-C levels
Time Frame: Baseline, Month 3 and Month 6
Change from baseline of LDL-C levels for QCZ484 + Inclisiran at Month 3 and 6.
Baseline, Month 3 and Month 6
Number of participants with Treatment-emergent adverse event and abnormal changes in laboratory parameters, vital signs and other safety assessments
Time Frame: Up to month 12
Number of participants with treatment-emergent adverse event, abnormal changes in laboratory parameters, vital signs and other safety assessments up to Month 12.
Up to month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2026

Primary Completion (Estimated)

April 28, 2027

Study Completion (Estimated)

February 3, 2028

Study Registration Dates

First Submitted

May 20, 2026

First Submitted That Met QC Criteria

May 20, 2026

First Posted (Actual)

May 27, 2026

Study Record Updates

Last Update Posted (Actual)

July 30, 2026

Last Update Submitted That Met QC Criteria

July 29, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHDY015A12201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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