A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia
Start Date
5/29/2026
Completion Date
2/3/2028
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.
Detailed Description
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
Age Range: 18 years to 75 years
Interventions
QCZ484
Inclisiran
QCZ484 placebo
Inclisiran placebo
Conditions
Locations
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