Last Update: Jul 30, 2026 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 ClinicalTrials.gov Identifier: [NCT07610278](https://clinicaltrials.gov/ct2/show/NCT07610278) Novartis Reference Number:CHDY015A12201 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description 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. 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. Condition Hypercholesterolaemia Phase Phase2 Overall Status Recruiting Number of Participants120 Start Date May 29, 2026 Completion Date Feb 03, 2028 Gender All Age(s) 18 Years - 75 Years (Adult, Older Adult) ## Interventions Drug ### Inclisiran Inclisiran once on Day 1 Drug ### Inclisiran placebo Inclisiran placebo once on Day 1 Drug ### QCZ484 QCZ484 once on Day 1 Drug ### QCZ484 placebo QCZ484 placebo once on Day 1 ## 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 United States #### Walker Family Care Recruiting Little River,South Carolina,29566,United States ###### Madelyn Poore Email: ###### Stephen D Grubb #### Universal Axon Clinical Research Recruiting Doral,Florida,33166,United States ###### Glenda Padron Email: ###### Luis Martinez #### Entrust Clinical Research Recruiting Miami,Florida,33176,United States ###### Adolfo Cueli ###### Daimelys Garcia Email: #### American Research Centers of FL Recruiting Pembroke Pines,Florida,33027,United States ###### Liliana Portal Email: ###### Luis Del Prado Rodriguez #### East Coast Inst for Research LLC Recruiting Saint Augustine,Florida,32086,United States ###### Ferris George ###### Rebecca Fink Phone: [+1 904 824 1776#116]() Email: #### Monroe Research Llc Recruiting West Monroe,Louisiana,71291,United States ###### Assad Mouhaffel ###### Nina Parrott Email: #### Anderson Medical Research Recruiting Ft. 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