Clinical Research Directory

A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia

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.

An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia

TRAP-HC is a multicenter, observational, longitudinal, prospective study designed to evaluate real-world treatment patterns and lipid-lowering therapy (LLT) management in patients with hypercholesterolemia, including familial hypercholesterolemia (FH), who are at high, very high, or extreme cardiovascular risk. Approximately 2,500 adult patients will be enrolled across up to 15 Italian LIPIGEN network centers and followed for 12 months as part of routine clinical practice. The study aims to assess LDL-C goal attainment according to current European guidelines, evaluate changes in lipid profiles over time, and investigate treatment adherence, persistence, and therapeutic modifications in response to clinical needs. Data collected during routine visits will include lipid parameters, cardiovascular history, concomitant therapies, safety outcomes, and patient-reported adherence measures. By providing real-world evidence on the management of hypercholesterolemia in high-risk populations, the study seeks to identify current gaps between guideline recommendations and clinical practice and to support optimization of cardiovascular risk reduction strategies.

Specified Drug-use Survey of Leqvio for s.c. Injection.

The objective of this study is to evaluate the long-term safety of Leqvio in patients with familial hypercholesterolaemia or hypercholesterolaemia in post-marketing clinical practice

A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias

This is a single-arm, open-label, multicenter, ascending dose Phase 1 trial that will enroll participants 18 to 75 years of age with dyslipidemias that are refractory to available treatments.

Impact of Phytosterol-Rich Extract on Lipid Profile

The aim of this randomized, parallel, two-arm, placebo-controlled, triple-blind clinical trial is to evaluate the efficacy of a phytosterol- and phytostanol-rich extract on lipid profile parameters in individuals with hypercholesterolemia, focusing primarily on total cholesterol and LDL cholesterol levels.

Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes

This is a phase 3, randomized, placebo-controlled study of the efficacy and safety of enlicitide decanoate, an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in participants with high cardiovascular risk. The primary objective is to evaluate the efficacy of enlicitide decanoate compared with placebo in increasing the time to the first occurrence of major adverse cardiovascular events (MACE) including coronary heart disease (CHD) death, ischemic stroke, myocardial infarction (MI), acute limb ischemia or major amputation, or urgent arterial revascularization.

Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy

Evaluation of adherence, persistence and efficacy of treatment with alirocumab 300 mg in a real-life Italian population.

LATAM LOWERS LDL-C

This is an open label, patient-level 1:1 randomized clinical trial in a multi-country study aiming to evaluate the real-world impact of inclisiran + Usual Care (UC) vs UC alone on LDL-C lowering, patient-reported outcomes, and healthcare resource utilization in an in-hospital population of patients, admitted during the acute setting, stabilized and before discharge, following an acute cardiovascular event.

An Efficacy and Safety Study of Akkermansia Muciniphila AKM Lab-01 in Hypercholesterolaemia

The purpose of this study was to assess the safety and efficacy of AKM Lab-01 in subjects with hypercholesterolemia. This study will be conducted as a randomized, double-blind, placebo-controlled trial, eligible hypercholesterolemic participants were administered daily oral doses of either AKM Lab-01 or a placebo. Baseline clinical parameters, blood samples, and stool specimens were collected before and after the intervention for comparative analysis.