A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QCZ484, Inclisiran, QCZ484 placebo, Inclisiran placebo.
- Who it may be relevant to
- Registry conditions: Hypercholesterolaemia. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug QCZ484
QCZ484 once on Day 1 - Drug Inclisiran
Inclisiran once on Day 1 - Drug QCZ484 placebo
QCZ484 placebo once on Day 1 - Drug Inclisiran placebo
Inclisiran placebo once on Day 1
Primary outcome measures
- Percent change from baseline of PCSK9 levels [Time frame: Baseline and Month 3]
- Percent change from baseline of AGT levels [Time frame: Baseline and Month 3]
Secondary outcome measures (3)
- Change from baseline of systolic blood pressure [Time frame: Baseline, Month 3 and Month 6]
- Change from baseline of LDL-C levels [Time frame: 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 [Time frame: Up to month 12]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 29 centers
- G and L Research LLC — Foley
- The Center for Clinical Trials — Saraland
- Clinical Trials Research — Lincoln
- Downtown L A Research Center Inc — Los Angeles
- Valley Clinical Trials — Northridge
- Flourish Medical Clinical Trials — Boca Raton
- Clinical Research of Brandon LLC — Brandon
- ALL Medical Research LLC — Cooper City
- … and 21 more centers
Identifiers
NCT: NCT07610278 · CHDY015A12201