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RecruitingNCT07610278Updated Jul 30, 2026

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

A Phase 2 interventional study of QCZ484 and Inclisiran in Hypercholesterolaemia, sponsored by Novartis Pharmaceuticals. Recruiting at 29 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the 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.
02

Conditions studied

  • Hypercholesterolaemia

Keywords

  • Hypertension
  • hypercholesterolemia
  • siRNA
  • inclisiran
  • QCZ484
  • randomized
  • double-blind
  • Phase 2
  • pharmacodynamics
  • AGT
  • PCSK9
03

In context

Hypercholesterolemia

1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.

This study's planned enrollment of 120 is close to the median of 110 across 975 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.

Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.

Browse Novartis Pharmaceuticals studies →All Novartis studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ) 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

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    QCZ484 + Inclisiran

    QCZ484 + inclisiran, once on Day 1

    Drug: QCZ484 · Drug: Inclisiran

  • Active comparator
    QCZ484

    QCZ484 + inclisiran placebo, once on Day 1

    Drug: QCZ484

  • Active comparator
    Inclisiran

    Inclisiran + QCZ484 placebo, once on Day 1

    Drug: Inclisiran

  • Placebo comparator
    Placebo

    QCZ484 placebo + inclisiran placebo, once on Day 1

    Drug: QCZ484 placebo · Drug: Inclisiran placebo

Interventions

  • DrugQCZ484

    QCZ484 once on Day 1

  • DrugInclisiran

    Inclisiran once on Day 1

    Also known as: KJX839, Leqvio

  • DrugQCZ484 placebo

    QCZ484 placebo once on Day 1

  • DrugInclisiran placebo

    Inclisiran placebo once on Day 1

06

What researchers measure

Primary outcomes

  1. Percent change from baseline of PCSK9 levels

    Percent (%) change from baseline of PCSK9 levels for QCZ484 + Inclisiran at Month 3

    Time frame: Baseline and Month 3

  2. Percent change from baseline of AGT levels

    Percent (%) change from baseline of AGT levels for QCZ484 + Inclisiran at Month 3

    Time frame: Baseline and Month 3

Secondary outcomes

  1. Change from baseline of systolic blood pressure

    Change from baseline of systolic blood pressure for QCZ484 + Inclisiran at Month 3 and 6.

    Time frame: Baseline, Month 3 and Month 6

  2. Change from baseline of LDL-C levels

    Change from baseline of LDL-C levels for QCZ484 + Inclisiran at Month 3 and 6.

    Time frame: Baseline, Month 3 and Month 6

  3. Number of participants with Treatment-emergent adverse event and abnormal changes in laboratory parameters, vital signs and other safety assessments

    Number of participants with treatment-emergent adverse event, abnormal changes in laboratory parameters, vital signs and other safety assessments up to Month 12.

    Time frame: Up to month 12

07

Study locations

29 of 29 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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/.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07610278
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
May 27, 2026
Start date
May 29, 2026
Primary completion
Apr 28, 2027 (estimated)
Completion
Feb 3, 2028 (estimated)
Last update
Jul 30, 2026

Study contacts

Novartis Pharmaceuticals
Contact
novartis.email@novartis.com
1-888-669-6682
Novartis Pharmaceuticals
Contact
Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: QCZ484 · Inclisiran

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