Crystal River

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating the efficacy, safety, and tolerability of a study drug called elecoglipron compared with oral semaglutide in adults with Type 2 Diabetes Mellitus T2DM who have an increased risk of cardiovascular events. The study focuses on adults whose diabetes is not adequately controlled by lifestyle changes or stable treatment with other glucose-lowering medications. This is a phase III randomized trial sponsored by AstraZeneca, aiming to compare these two oral medications in managing T2DM and cardiovascular risk. Participants will be assigned to receive either elecoglipron or semaglutide, both administered orally once daily at specified doses. The study runs in parallel groups, with one group receiving elecoglipron and the other receiving semaglutide. Treatment and observation will continue for 52 weeks, during which the effects on blood sugar control and other health indicators will be evaluated. Throughout the 52-week study period, participants will undergo regular assessments including measurements of Hemoglobin A1c HbA1c, body weight, and blood pressure. Researchers will monitor changes from baseline to week 52 to understand the drugs impact on diabetes control and cardiovascular risk factors. The study also tracks safety and tolerability to ensure participant wellbeing during the trial.

Researchers are studying the effects and safety of berobenatide PF-08653944 in adults with overweight or obesity, including some who may also have type 2 diabetes. The main goal is to compare how people receiving berobenatide fare compared to those receiving a placebo, assessing if the study medicine helps with weight loss and is safe to use. This is a Phase 3 interventional clinical trial sponsored by Pfizer. Participants will receive berobenatide or a matching placebo by injection under the skin in the belly area. The trial uses a randomized, double-blind, placebo-controlled design with multiple treatment arms. Treatment is given once monthly, and the study will last about 20 months, during which participants will attend approximately 15 in-person visits and 2 phone visits. During the study, participants will be monitored through regular visits that include assessments of body weight, waist circumference, blood pressure, blood tests, and questionnaires about quality of life and eating behavior. Researchers will track safety outcomes such as adverse events and changes in metabolic and inflammatory markers. The primary outcome is the percent change in body weight from the start of the study to week 72, with ongoing follow-up to assess the treatments effects and safety.

Researchers are conducting an international, multicenter, observational study to assess the performance of the Cordio HearO system in patients with symptomatic chronic heart failure. This non-interventional, prospective, single-arm study aims to collect patient voice recordings to analyze the sensitivity and unique patient noise reduction UPNR capabilities of the HearO device. The study is sponsored by Cordio Medical and focuses on monitoring heart failure events over time. The study consists of two periods a Run-In period where patients submit daily recordings to establish a baseline, followed by a Core period where patients continue daily submissions for up to 24 months or until the study ends. There is no active treatment or intervention beyond data collection using the HearO app, which records patient utterances for later analysis. Participants will submit daily voice recordings throughout the study duration. Researchers will monitor heart failure events, defined as first usable and adjudicated heart failure events, as the primary outcome. The study involves regular data collection without additional interventions, focusing on patient adherence to daily use of the app. The total observation period per participant may last up to 24 months or until a predefined number of heart failure events have occurred.

Neurotrophic keratopathy NK is a degenerative eye disease caused by damage to the nerves that supply the cornea, leading to reduced sensitivity and impaired healing of the corneal surface. Researchers are evaluating the safety and effectiveness of a new eye drop solution called 0.1% RGN-259 compared to a placebo for treating this condition. This Phase 3, randomized, multi-center clinical study aims to better understand how well RGN-259 helps heal the cornea in people with NK. Participants will be randomly assigned to receive either the RGN-259 eye drops or a placebo solution. Both treatments are preservative-free, sterile eye drops applied directly into the affected eyes five times daily for 28 days. The RGN-259 contains thymosin beta 4 T4, which is being studied for its potential healing properties, while the placebo has the same ingredients except for T4. The study is double-masked to ensure unbiased results. During the study, participants will have regular assessments including eye examinations, measurements of corneal healing, visual acuity tests, and corneal sensitivity checks using specialized tools. The main outcome measured is the percentage of subjects who achieve complete healing of the persistent epithelial defect by Day 29. Follow-up visits will continue up to Day 43 to monitor changes in lesion size and corneal health. Safety will also be closely monitored throughout the trial, which is expected to end in May 2026.

Researchers are evaluating a new atrioventricular interval modulation AVIM algorithm designed for dual-chamber Medtronic AstraAzure pacemakers. This multinational, randomized, double-blind clinical trial aims to assess the safety and effectiveness of this AVIM therapy in patients with hypertension who either have or are scheduled to receive these pacemakers. The study is led by Orchestra BioMed, Inc and focuses on managing high blood pressure through this innovative device approach. The trial includes three phases a screening phase, a one-year double-blind randomized phase, and a two-year unblinded phase. Participants who meet eligibility criteria will have the investigational AVIM therapy software downloaded into their AstraAzure pacemaker. They will be randomly assigned to either have the AVIM therapy activated along with their stable antihypertensive drug treatment or have the AVIM therapy deactivated while continuing their usual drug therapy. Participants will be monitored over the course of the study, with the main outcomes measured including changes in 24-hour ambulatory systolic blood pressure at three months and the occurrence of any unanticipated serious adverse device effects. Throughout the study, subjects will continue their antihypertensive medications and undergo regular assessments to evaluate blood pressure control and device safety. The total study duration extends up to five years, allowing for long-term follow-up and evaluation.

Researchers are studying the use of depemokimab as an additional treatment for adults aged 40 to 75 with moderate to severe Chronic Obstructive Pulmonary Disorder COPD who also have type 2 inflammation. The goal is to evaluate the effectiveness and safety of starting depemokimab early alongside the standard care these patients already receive. This study is a Phase 3 trial designed to better understand how depemokimab might help reduce COPD exacerbations in this specific group. Participants will be randomly assigned to receive either depemokimab or a matching placebo, both given in combination with their existing standard treatments for COPD. The treatment period lasts up to 156 weeks about 3 years, during which the study compares the rate of moderate to severe COPD flare-ups between the two groups. This trial uses a parallel design with quadruple masking to maintain objectivity and includes ongoing standard care throughout. Throughout the study, participants will have regular evaluations to monitor their lung function, symptoms, and quality of life using questionnaires like the St. Georges Respiratory Questionnaire and the Evaluating Respiratory Symptoms E-RS for COPD. The main outcome measured is the annual rate of moderate or severe exacerbations over the study period. Safety and response to treatment will be closely observed, with follow-up continuing until the primary completion date in April 2029 and final study completion in June 2029.

This research aims to evaluate the effects of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with a systolic blood pressure of at least 130 mmHg, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial focusing on preventing heart failure events and cardiovascular death. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those starting the baxdrostatdapagliflozin treatment may begin with a lower baxdrostat dose that can be increased if certain criteria are met. A run-in period with dapagliflozin alone for 4 to 6 weeks may occur for those not previously treated or treated less than 4 weeks with SGLT2 inhibitors. Treatment visits will occur at about 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months until study closure. Participants will undergo screening for eligibility within a 14-day period, with an optional pre-screening phase that does not require site visits or consent. During the study, regular assessments including monitoring for heart failure events and cardiovascular outcomes will be conducted. If participants stop the blinded treatment early, they may continue with open-label dapagliflozin unless specific discontinuation criteria apply. The study will continue until a predetermined number of cardiovascular events occur, with ongoing data collection and visits according to protocol.