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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 · Novartis
In plain English
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Official title
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
About this study
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.
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
Study design
Enrollment target: 120 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-05-29
Estimated completion: 2028-01-28
Last updated: 2026-06-23
Interventions
Drug: QCZ484Drug: InclisiranDrug: QCZ484 placeboDrug: Inclisiran placebo
Primary outcomes
- • Percent change from baseline of PCSK9 levels (Baseline and Month 3)
- • Percent change from baseline of AGT levels (Baseline and Month 3)
Sponsor
Novartis Pharmaceuticals · industry
Contacts & investigators
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · 1-888-669-6682
ContactNovartis Pharmaceuticals · contact
InvestigatorNovartis Pharmaceuticals · study_director, Novartis Pharmaceuticals
All locations (26)
G and L Research LLCRecruiting
Foley, Alabama, United States
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Saraland, Alabama, United States
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Lincoln, California, United States
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Monroe, North Carolina, United States
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Little River, South Carolina, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Manassas, Virginia, United States
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Richmond, Virginia, United States