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

NCT07610278

RecruitingPhase 2

Sponsor: Novartis Pharmaceuticals

Conditions: Hypercholesterolaemia

Interventions: QCZ484, Inclisiran, QCZ484 placebo, Inclisiran placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (29)

Foley, Alabama, United States
Saraland, Alabama, United States
Lincoln, California, United States
Los Angeles, California, United States
Northridge, California, United States
Boca Raton, Florida, United States
Brandon, Florida, United States
Cooper City, Florida, United States
Coral Gables, Florida, United States
Doral, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
Miami Lakes, Florida, United States
Pembroke Pines, Florida, United States
Saint Augustine, Florida, United States
Canton, Georgia, United States
Chicago, Illinois, United States
Niles, Illinois, United States
Wichita, Kansas, United States
West Monroe, Louisiana, United States
Ft. Washington, Maryland, United States
Lanham, Maryland, United States
Monroe, North Carolina, United States
Little River, South Carolina, United States
Houston, Texas, United States
Houston, Texas, United States
Manassas, Virginia, United States
Richmond, Virginia, United States