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
Status: Recruiting
Location: See all (29) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
G and L Research LLC
RECRUITING
Foley
The Center for Clinical Trials
RECRUITING
Saraland
California
Clinical Trials Research
RECRUITING
Lincoln
Downtown L A Research Center Inc
RECRUITING
Los Angeles
Valley Clinical Trials
RECRUITING
Northridge
Florida
Flourish Medical Clinical Trials
RECRUITING
Boca Raton
Clinical Research of Brandon LLC
RECRUITING
Brandon
ALL Medical Research LLC
RECRUITING
Cooper City
AMR Miami
RECRUITING
Coral Gables
Universal Axon Clinical Research
RECRUITING
Doral
East Coast Institute for Research
RECRUITING
Jacksonville
Entrust Clinical Research
RECRUITING
Miami
Inpatient Research Clinical LLC
RECRUITING
Miami Lakes
Inpatient Research Clinical LLC
RECRUITING
Miami Lakes
American Research Centers of FL
RECRUITING
Pembroke Pines
East Coast Inst for Research LLC
RECRUITING
Saint Augustine
Georgia
East Coast Research
RECRUITING
Canton
Illinois
Great Lakes Clinical Trials
RECRUITING
Chicago
AMR Chicago
RECRUITING
Niles
Kansas
Alliance for Multispecialty Research
RECRUITING
Wichita
Louisiana
Monroe Research Llc
RECRUITING
West Monroe
Maryland
Anderson Medical Research
RECRUITING
Ft. Washington
Capitol Cardiology Associates
RECRUITING
Lanham
North Carolina
Monroe Biomedical Research
RECRUITING
Monroe
South Carolina
Walker Family Care
RECRUITING
Little River
Texas
Synergy Group Medical LLC
RECRUITING
Houston
Synergy Group Medical LLC
RECRUITING
Houston
Virginia
Manassas Clinical Research Center
RECRUITING
Manassas
Dominion Medical Associates
RECRUITING
Richmond
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
Time Frame
Start Date:2026-05-29
Estimated Completion Date:2028-02-03
Participants
Target number of participants:120
Treatments
Experimental: QCZ484 + Inclisiran
QCZ484 + inclisiran, once on Day 1
Active_comparator: QCZ484
QCZ484 + inclisiran placebo, once on Day 1
Active_comparator: Inclisiran
Inclisiran + QCZ484 placebo, once on Day 1
Placebo_comparator: Placebo
QCZ484 placebo + inclisiran placebo, once on Day 1