Search Bar & Filters
Found 49 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.
Actively Recruiting
Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.
Actively Recruiting
Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection, in adults with type 1 diabetes. The study aims to see how well weekly insulin icodec controls blood sugar levels compared to daily insulin glargine when both are combined with insulin aspart. This phase 3 study will last about 26 weeks, or roughly 8.5 months. Participants will receive either insulin icodec or insulin glargine, both given as subcutaneous injections. All participants will also use insulin aspart as a subcutaneous injection. The study compares these two insulin regimens to assess their effects on blood sugar control over the 26-week period. During the study, researchers will monitor changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 26. Participants will follow the study protocol including self-measured plasma glucose profiles. Safety and efficacy will be evaluated throughout the treatment period to understand the impact of the insulin regimens on blood sugar control and participant health.
Actively Recruiting
This research aims to evaluate the safety and effectiveness of a drug called DII235 in adults who have high levels of lipoprotein(a), a condition linked to lipoprotein disorder. The study focuses on adults aged 18 to 80 years who also have evidence of atherosclerotic cardiovascular disease or type 2 diabetes. This is a Phase 2 study designed to identify the best dose of DII235 and understand its impact on lipoprotein(a). Participants will be randomly assigned to receive either DII235 or a placebo in a controlled, double-blind manner to ensure unbiased results. The study involves administering DII235 or a saline placebo as solutions for injection. The trial is designed as a multi-center, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study. Participants will receive different doses of DII235 or the placebo, and their responses will be compared over time to evaluate the drug's effects on lipoprotein(a) levels. The dosing and treatment schedules are carefully monitored to assess the safety, tolerability, and appropriate dosage levels of DII235. Participants will be followed and evaluated through various assessments, including measuring the percentage change from their baseline lipoprotein(a) levels between Day 60 and Day 180, and also between Day 60 and Day 360 for different doses. Safety and tolerability will be closely monitored throughout the study duration. The trial includes regular laboratory testing and clinical evaluations to track participant health and treatment response. Overall participation in the study spans several months to capture both short-term and longer-term effects of the treatment.
Actively Recruiting
Researchers are evaluating the workflow of a pulsed field (PF) ablation system using the VARIPULSE catheter and TRUPULSE generator with new VARIPULSE Pro software in people with two types of irregular heartbeat: paroxysmal atrial fibrillation (PAF), where episodes start and stop on their own, and persistent atrial fibrillation (PsAF), which lasts over 7 days and does not stop on its own. The study focuses on how this system works in treating these heart rhythm disorders. The study uses the pulsed field ablation system, which includes the VARIPULSE catheter and TRUPULSE generator with VARIPULSE Pro software, to perform cardiac ablation. This procedure aims to isolate pulmonary veins or treat atrial flutter. The exact treatment details, such as dosing or schedules, are not described, but the intervention involves applying pulsed fields to the heart tissue. Participants will undergo the ablation procedure while various measurements are taken during the operation, including total procedure time, pulsed field application time, number of applications per pulmonary vein and other heart locations, pulmonary vein isolation time, fluoroscopy time, catheter dwell time, and acute effectiveness. Monitoring and follow-up requirements are not detailed, but participants must comply with all testing and follow-up as part of the study.
Actively Recruiting
Researchers are investigating how cardiac surgery-associated acute kidney injury (CSA-AKI) develops in people undergoing heart surgeries with the use of a heart-lung machine. CSA-AKI is a common complication where the kidneys stop working properly after heart surgery. Factors increasing the risk include older age, kidney disease, diabetes, and longer use of the heart-lung machine during surgery. The study focuses on understanding the mechanisms of CSA-AKI by examining biomarkers in blood and urine, especially in the early hours and days after surgery. Participants will not receive any experimental treatments. Instead, they will undergo heart surgery and related medical care as planned by their doctors. The study involves collecting blood and urine samples before and after surgery and reviewing medical records during hospitalization. No investigational interventions will be given; the research only adds sample collection and data review to standard care. Each participant will be involved for up to two months. During this time, the study team will monitor their overall health, collect biological samples, and assess medical data to compare those who develop CSA-AKI within a week after surgery to those who do not. The main measurement is the number of participants who develop CSA-AKI up to three days post-surgery. This research aims to improve understanding of CSA-AKI and help develop future treatments to prevent it.
Actively Recruiting
Researchers are conducting a global Phase 2b clinical trial called FORTITUDE-HCM to evaluate the safety and effectiveness of the drug ninerafaxstat compared to a placebo in patients who have symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM). This condition involves thickening of the heart muscle without obstruction, leading to symptoms affecting heart function. The study aims to improve symptoms and quality of life in these patients by adding ninerafaxstat to their standard care. Participants will be randomly assigned to receive either ninerafaxstat 200mg modified release tablets or matching placebo tablets, both taken twice daily. The treatments will be given in a double-blind manner, meaning neither participants nor researchers know who receives the active drug or placebo. The study uses a parallel-group design to compare the effects of the drug against placebo over the course of the trial. During the study, participants will be monitored through various assessments, including evaluations of heart function and exercise capacity. The main outcome measured is the change in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score from the start of the study to 12 weeks, which reflects changes in symptoms and quality of life. Participants will undergo screening tests such as echocardiography and exercise stress tests to confirm diagnosis and functional limitations. Safety and treatment effects will be closely observed throughout the trial.
Actively Recruiting
The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.
Actively Recruiting
Researchers are collecting clinical data to evaluate the ongoing safety and performance of commercially approved Biosense Webster Inc. (BWI) medical devices used in standard cardiac arrhythmia mapping and ablation procedures. The study focuses on patients diagnosed with cardiac arrhythmias such as atrial fibrillation, supraventricular tachycardia, or ventricular tachycardia. The goal is to confirm safety and performance of these devices in real-world use and to expand the evidence on their application in treating arrhythmias. Participants will be treated with commercially approved BWI medical devices following routine clinical practice. Sub-studies include participants treated with the Varipulse Catheter and the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter. No specific intervention or experimental procedure will be imposed for the study; the treatments follow standard care procedures. During the study, researchers will monitor safety by tracking adverse events related to the devices or procedures within seven days of treatment. They will also assess treatment effectiveness by evaluating specific outcomes such as isolation of pulmonary veins, non-inducibility of targeted tachycardias, and elimination of ventricular arrhythmias. Follow-up and compliance with standard hospital testing and care are expected as part of the participant involvement.
Actively Recruiting
This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed the parent trial CTQJ230A12301. The study is an open-label extension following the phase 3 parent study, providing participants continued access to pelacarsen after the initial trial. Participants will receive pelacarsen 80 mg by subcutaneous injection once a month during this open-label extension. The study is single-arm and multicenter, focusing on continued treatment with pelacarsen for up to 36 months after completion of the parent study. Throughout the study, participants will be monitored regularly to assess safety and tolerability, with particular attention to adverse events occurring up to 36 months. Researchers will collect data on health status throughout this period to understand the long-term effects of pelacarsen in this patient population.
1-10 of 49
1