NCT07610278RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 30 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 20 May 2026
- Start date
- 29 May 2026
- Primary completion date
- 28 Apr 2027
- Lead sponsor
- Novartis Pharmaceuticals
- NCT number
- NCT07610278
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 29 May 2026 to the primary completion date, 28 Apr 2027
- 27 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with certain medications and/or unable to comply with prohibited medications requirements.
- Other protocol inclusion/exclusion criteria may apply
Other
- Symptomatic orthostatic hypotension.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Flourish Medical Clinical Trials Coordinator of this site? Confirm its status | Boca Raton | United States | Recruiting |
| Clinical Research of Brandon, LLC Coordinator of this site? Confirm its status | Brandon | United States | Recruiting |
| East Coast Research Coordinator of this site? Confirm its status | Canton | United States | Recruiting |
| Great Lakes Clinical Trials Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| ALL Medical Research, LLC Coordinator of this site? Confirm its status | Cooper City | United States | Recruiting |
| AMR Miami Coordinator of this site? Confirm its status | Coral Gables | United States | Recruiting |
| Universal Axon Clinical Research Coordinator of this site? Confirm its status | Doral | United States | Recruiting |
| G and L Research LLC Coordinator of this site? Confirm its status | Foley | United States | Recruiting |
| Anderson Medical Research Coordinator of this site? Confirm its status | Ft. Washington | United States | Recruiting |
| Synergy Group Medical,LLC Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| East Coast Institute for Research Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Capitol Cardiology Associates Coordinator of this site? Confirm its status | Lanham | United States | Recruiting |
| Clinical Trials Research Coordinator of this site? Confirm its status | Lincoln | United States | Recruiting |
| Walker Family Care Coordinator of this site? Confirm its status | Little River | United States | Recruiting |
| Downtown L.A. Research Center, Inc. Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Manassas Clinical Research Center Coordinator of this site? Confirm its status | Manassas | United States | Recruiting |
| Entrust Clinical Research Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Inpatient Research Clinical LLC Coordinator of this site? Confirm its status | Miami Lakes | United States | Recruiting |
| Monroe Biomedical Research Coordinator of this site? Confirm its status | Monroe | United States | Recruiting |
| AMR Chicago Coordinator of this site? Confirm its status | Niles | United States | Recruiting |
| Valley Clinical Trials Coordinator of this site? Confirm its status | Northridge | United States | Recruiting |
| American Research Centers of FL Coordinator of this site? Confirm its status | Pembroke Pines | United States | Recruiting |
| Dominion Medical Associates Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| East Coast Inst for Research LLC Coordinator of this site? Confirm its status | Saint Augustine | United States | Recruiting |
| The Center for Clinical Trials Coordinator of this site? Confirm its status | Saraland | United States | Recruiting |
| Monroe Research, LLC Coordinator of this site? Confirm its status | West Monroe | United States | Recruiting |
| Alliance for Multispecialty Research Coordinator of this site? Confirm its status | Wichita | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.