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The purpose of this study is to evaluate inclisiran sodium 300 mg s.c. (equivalent to 284 mg inclisiran) compared to placebo on reducing the risk of 4P-MACE in adult patients at high risk for their first major adverse cardiovascular event. Randomized participants will receive study medication (inclisiran or placebo), administered s.c. on Day 1, Day 90, then every 6 months thereafter. This is an event-driven study. Therefore, the study will continue until the required number of clinical events have occurred across both treatment arms, and all participants have a minimum of 3 years of follow-up during the double-blind treatment period.
Location(s): Canton, Jacksonville (Headquarters), Jacksonville - LaVilla (Downtown), Lake City, Macon, Southside, St. Augustine
Condition: Heart Disease
The main purpose of this study is to investigate the effects of switching from glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy to tirzepatide glucose-dependent insulinotropic polypeptide (GIP) GLP-1 RA agonist in participants with type 2 diabetes (T2D).
Location(s): Jacksonville - LaVilla (Downtown)
Condition: Diabetes
The purpose of this study is to evaluate the effect of zilebesiran on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of zilebesiran as add-on therapy.
Location(s): Canton, Jacksonville (Headquarters), Jacksonville - LaVilla (Downtown), Lake City, Macon, St. Augustine
Condition: Hypertension
The primary objective of this study is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).
Location(s): Jacksonville (Headquarters), Jacksonville - LaVilla (Downtown), St. Augustine
Condition: Heart Disease
The purpose of this study is to evaluate the efficacy and safety of vericiguat in participants with chronic heart failure with reduced ejection fraction (HFrEF), specifically those with symptomatic chronic HFrEF who have not had a recent hospitalization for heart failure or need for outpatient intravenous (IV) diuretics. The primary hypothesis is that vericiguat is superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization.
Location(s): Jacksonville (Headquarters), St. Augustine
Condition: Heart Failure
The main study purpose is to demonstrate the non-inferiority of T4032 compared to Lumigan® 0.01% in terms of efficacy.
Location(s): Jacksonville - Florida Eye Specialist (Gate)
Condition: Ocular Hypertension, Open Angle Glaucoma
The purpose of this study is to evaluate the efficacy and safety of OCS-01 Ophthalmic Suspension versus placebo (vehicle) in the treatment of inflammation and pain following cataract surgery.
Location(s): Jacksonville - Florida Eye Specialist (Gate)
Condition: Cataract
The objective of this clinical study is to evaluate the safety and efficacy of NCX 470 Ophthalmic Solution in lowering intraocular pressure (IOP) in subjecs with ocular hypertension or open-angle glaucoma. Subjects will be randomized in a 1:1 ratio to NCX 470 0.1% or to latanoprost 0.005% to be administered to both eyes once daily in the evening for up to 12 months.
Location(s): Jacksonville - Florida Eye Specialist (Gate)
Condition: Ocular Hypertension, Open Angle Glaucoma, Ophthalmology
This study is conducted to see if ziltivekimab reduces the risk of having cardiovascular events (for example heart attack and stroke) in people with cardiovascular disease, chronic kidney disease and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). This is known as the study medicine. Which treatment participants get is decided by chance. Participants chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine doctors cannot prescribe. Participants will get the study medicine in a pre filled syringe. Participants will need to use the pre filled syringe to inject the study medicine into a skinfold once-monthly. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have blood and urine samples taken at most of the clinic visits. Participants will have their heart examined using sound waves (echocardiography) and electrodes (electrocardiogram). Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.
Location(s): Jacksonville (Headquarters)
Condition: Heart Disease, Kidney Disease
The ORION-4 study aims to provide evidence about both the efficacy and safety of inclisiran. Inclisiran is a PCKS9 synthesis inhibitor which has been found to reduce LDL-cholesterol by about 50-60%. ORION-4 will investigate the effects of inclisiran on major adverse cardiovascular events. The study is intended to be conducted at approximately 180 clinical sites in the UK and the USA. Approximately 15,000 participants aged 40 years or older for men, and 55 years or older for women, with pre-existing atherosclerotic cardiovascular disease will be randomized between inclisiran sodium 300 mg and matching placebo (given by subcutaneous injection on the day of randomization, at 3 months and then every 6-months) in a 1:1 ratio for a planned median duration of about 5 years.
Location(s): Jacksonville (Headquarters), Jacksonville - LaVilla (Downtown), Lake City, Macon, St. Augustine
Condition: Cholesterol, Heart Disease
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with underlying heterozygous familial hypercholesterolemia (HeFH) and/or ASCVD to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy.
Location(s): Canton, Jacksonville (Headquarters), Jacksonville - LaVilla (Downtown), Lake City, Macon, St. Augustine
Condition: Cholesterol, Heart Disease
This study is a multi-center, single arm study in insulin-requiring adult and pediatric subjects with type 1 diabetes on the MiniMed™ 780G system using Lyumjev® insulin lispro-aabc and Medtronic Extended infusion set and reservoir. The run-in period and study period will be approximately 120 days long. A total of up to 250 subjects with insulin-requiring type 1 diabetes age 7-80 will be enrolled at up to 25 investigational centers across the United States in order to have at least 200 subjects enter the study period. Up to 125 subjects will be enrolled in the pediatric age group (7-17 years of age) and up to 125 in the adult age group (18 years or older).
Location(s): Macon
Condition: Diabetes
MiniMed™ 780G system in adult subjects with insulin-requiring type 2 diabetes in a home setting. The combined run-in period and study period will be approximately 135 days long. At the conclusion of the 90-day study period, subjects will be given the opportunity to transition to a period of continued access. They will be allowed to continue using the study device system until further notice from Sponsor. A total of at least 300 subjects with insulin-requiring type 2 diabetes age 18-80 will be enrolled at up to 25 investigational centers across the United States, using the 780 insulin pump in combination with Guardian 4 sensor and Guardian 4 transmitter.
Location(s): Canton, Jacksonville - LaVilla (Downtown)
Condition: Diabetes
The purpose of this study is to determine the effect and safety of LY3209590 compared to degludec in adult participants with type 2 diabetes who are starting basal insulin for the first time. Additional participants will continue to be enrolled in a maximum extended enrollment cohort.
Location(s): Canton, Jacksonville - LaVilla (Downtown)
Condition: Diabetes