🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT05202509
Active, not recruiting Phase 3

Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease

NCT05202509 · tracked via the Priya Life Science UK tracker
Sponsor
NewAmsterdam Pharma
Phase
Phase 3
Started
2022-02-07
Last updated
2024-06-04

Condition(s) studied

Atherosclerotic Cardiovascular Disease

Investigational drug(s) / intervention(s)

ObicetrapibPlacebo

Obicetrapib: 10mg obicetrapib tablet

Placebo: Placebo tablet to resemble obicetrapib

Study summary

This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with Atherosclerotic Cardiovascular Disease (ASCVD) who are not adequately controlled despite maximally tolerated lipid-lowering therapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Males \& females ≥ 18 years age. * Established ASCVD including: * Coronary artery disease * Cerebrovascular disease * Peripheral Artery disease * On maximally tolerated lipid-modifying therapy * Fasting LDL-C ≥ 55 mg/dL * Fasting triglycerides \< 400 mg/dL * Estimated glomerular filtration rate ≥ 30 mL/min Exclusion Criteria: * New York Heart Association class III or IV heart failure or left ventricular ejection fraction \< 30% * Have been hospitalized for Heart Failure within 5 years prior to screening * Had non-fatal MI, non-fatal stroke, non-elective coronary revascularization and/or hospitalization for unstable angina or chest pain within past 3 months prior to screening * Uncontrolled hypertension * Diagnosis of homozygous familial hypercholesterolemia (HoFH) * Active liver disease * HbA1c ≥10% * Thyroid Stimulating Hormone (TSH) \> 1.5 times upper limit normal * Creatine kinase \> 3 times upper limit normal * History of malignancy with surgery in past 3 years * History of alcohol or drug abuse within past 5 years * Received treatment with investigational product or device within past 30 days excluding Coronavirus treatment or vaccine * Known allergy to study drug * Participated in previous obicetrapib trial * Taking gemfibrozil within 30 days screening

Primary outcome measure(s)

Trial sites (591)

FacilityCityRegionStatus
Advanced Cardiovascular LLC Alexander City Alabama
Ascension - Cardiology Specialists of Birmingham Birmingham Alabama
Central Alabama Research Birmingham Alabama
Cardiovascular Associates of the Southeast, LLC Birmingham Alabama
Eastern Shore Research Institute, LLC Fairhope Alabama
The Heart Center Research Huntsville Alabama
Mobile Heart Specialists Mobile Alabama
Syed Research Consultants Muscle Shoals Alabama
Syed Research Consultants Sheffield Alabama
Elite Clinical Studies Phoenix Arizona
Clinical Research Institute of Arizona, LLC Sun City West Arizona
Eclipse Clinical Research Tucson Arizona
NEA Baptist clinic Jonesboro Arkansas
Cardiology and Medicine Clinic Little Rock Arkansas
Advanced Research Center Anaheim California
Westside Medical Associates of Los Angeles Beverly Hills California
Hope Clinical Research LLC Canoga Park California
Titan Medical Research - Oceanside Encinitas California
Clinical Trials Research Lincoln California
Torrance Clinical Research Institute Inc. Lomita California
American Institute of Research Los Angeles California
Amicis Research Center-Northridge Northridge California
Amicis Research Northridge California
Valley Clinical Trials, Inc Northridge California
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center Torrance California
Cardiology Associates of Fairfield County Norwalk Connecticut
Excel Medical Clinical Trials Boca Raton Florida
Clearwater Cardiovascular and Interventional Consultants Clearwater Florida
Innovative Research of West Florida Clearwater Florida
Avail Clinical Research DeLand Florida
Invesclinic Fort Lauderdale Florida
Qway Research Hialeah Florida
New Generation of Medical Research Hialeah Florida
East Coast Institute for Research Jacksonville Florida
East Coast Institute for Research - Jacksonville Monroe St Jacksonville Florida
East Coast Institute for Research - Jacksonville University Blvd Jacksonville Florida
East Coast Institute for Research - Perimeter Park Court Jacksonville Florida
East Coast Institute for Research- Lake City Lake City Florida
Columbus Clinical Services Miami Florida
Finlay Medical Research Corp Miami Florida

+ 551 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05202509 on ClinicalTrials.gov ↗ ← All trials in the UK