A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia
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
1 other identifier
interventional
120
1 country
29
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2026
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2026
CompletedFirst Posted
Study publicly available on registry
May 27, 2026
CompletedStudy Start
First participant enrolled
May 29, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 3, 2028
July 30, 2026
July 1, 2026
11 months
May 20, 2026
July 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percent change from baseline of PCSK9 levels
Percent (%) change from baseline of PCSK9 levels for QCZ484 + Inclisiran at Month 3
Baseline and Month 3
Percent change from baseline of AGT levels
Percent (%) change from baseline of AGT levels for QCZ484 + Inclisiran at Month 3
Baseline and Month 3
Secondary Outcomes (3)
Change from baseline of systolic blood pressure
Baseline, Month 3 and Month 6
Change from baseline of LDL-C levels
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
Up to month 12
Study Arms (4)
QCZ484 + Inclisiran
EXPERIMENTALQCZ484 + inclisiran, once on Day 1
QCZ484
ACTIVE COMPARATORQCZ484 + inclisiran placebo, once on Day 1
Inclisiran
ACTIVE COMPARATORInclisiran + QCZ484 placebo, once on Day 1
Placebo
PLACEBO COMPARATORQCZ484 placebo + inclisiran placebo, once on Day 1
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Symptomatic orthostatic hypotension.
- Treatment with certain medications and/or unable to comply with prohibited medications requirements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
G and L Research LLC
Foley, Alabama, 36535, United States
The Center for Clinical Trials
Saraland, Alabama, 36571, United States
Clinical Trials Research
Lincoln, California, 95648, United States
Downtown L A Research Center Inc
Los Angeles, California, 90017, United States
Valley Clinical Trials
Northridge, California, 91325, United States
Flourish Medical Clinical Trials
Boca Raton, Florida, 33434, United States
Clinical Research of Brandon LLC
Brandon, Florida, 33511, United States
ALL Medical Research LLC
Cooper City, Florida, 33024, United States
AMR Miami
Coral Gables, Florida, 33134, United States
Universal Axon Clinical Research
Doral, Florida, 33166, United States
East Coast Institute for Research
Jacksonville, Florida, 32216, United States
Entrust Clinical Research
Miami, Florida, 33176, United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014, United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014, United States
American Research Centers of FL
Pembroke Pines, Florida, 33027, United States
East Coast Inst for Research LLC
Saint Augustine, Florida, 32086, United States
East Coast Research
Canton, Georgia, 30114, United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640, United States
AMR Chicago
Niles, Illinois, 60714, United States
Alliance for Multispecialty Research
Wichita, Kansas, 67207, United States
Monroe Research Llc
West Monroe, Louisiana, 71291, United States
Anderson Medical Research
Ft. Washington, Maryland, 20744, United States
Capitol Cardiology Associates
Lanham, Maryland, 20706, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
Walker Family Care
Little River, South Carolina, 29566, United States
Synergy Group Medical LLC
Houston, Texas, 77061, United States
Synergy Group Medical LLC
Houston, Texas, 77061, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
Dominion Medical Associates
Richmond, Virginia, 23219, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Central Study Contacts
Novartis Pharmaceuticals
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2026
First Posted
May 27, 2026
Study Start
May 29, 2026
Primary Completion (Estimated)
April 28, 2027
Study Completion (Estimated)
February 3, 2028
Last Updated
July 30, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
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/.