Svidnik

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating the effectiveness, safety, and tolerability of ITI-1284 for people with agitation linked to Alzheimer's dementia. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study aims to compare ITI-1284 to a placebo in patients aged 55 years and older who meet specific criteria for Alzheimer's disease and agitation. Participants will be involved in three main periods: a screening phase of up to 4 weeks to confirm eligibility; a 12-week double-blind treatment phase where patients will be randomly assigned to receive either ITI-1284 (10 mg or 20 mg) or a placebo, both given once daily as a rapidly disintegrating tablet under the tongue; and a 30-day safety follow-up period after the last dose to monitor any safety concerns. During the study, participants will undergo various assessments including agitation severity measured by the Cohen-Mansfield Agitation Inventory at Week 12. Other evaluations include cognitive testing, clinical global impressions, and monitoring for side effects. Researchers will track adherence and safety through visits and questionnaires over the total study duration, which includes screening, treatment, and follow-up.

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.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are evaluating maridebart cafraglutide, a drug given as an addition to standard care, to see if it reduces heart-related problems and deaths better than a placebo in people with atherosclerotic cardiovascular disease who are overweight or obese. This phase 3 study focuses on cardiovascular events such as heart attacks, strokes, and deaths related to heart conditions, aiming to improve outcomes in this high-risk population. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study compares these two groups over a period of up to approximately 35 months, monitoring heart-related health events to assess the drug's impact. The placebo group will receive injections that look identical but contain no active drug, ensuring a double-blind study design. During the study, participants will be regularly evaluated for major cardiovascular events, including heart attack, stroke, heart failure, and death. Researchers will track the time until these events occur to measure the drug's effectiveness. Safety and health will be closely monitored throughout the study period, and participants will be followed for up to nearly three years to gather comprehensive data on cardiovascular outcomes and overall survival.

This research aims to evaluate the long-term safety and tolerability of NBI-1065845 when added to ongoing antidepressant treatment in adults diagnosed with Major Depressive Disorder (MDD). It focuses on participants who have experienced moderate or severe recurrent MDD or persistent depressive disorder and who have not responded adequately to oral antidepressants during their current depressive episode. This is a Phase 3, open-label study designed to monitor the effects of this adjunctive treatment over an extended period. Participants will receive NBI-1065845 tablets alongside their current oral antidepressant therapy. The study will observe treatment effects and monitor any adverse events that emerge during the course of therapy. There is no mention of a comparator or placebo group, indicating all enrolled individuals will be treated with NBI-1065845 in addition to their existing medication. The treatment and observation period extends through 52 weeks, allowing for comprehensive long-term safety assessment. During the study, participants will be regularly evaluated for treatment-emergent adverse events from the start through week 52. Researchers will track safety and tolerability through clinical assessments and monitoring. Participants must be willing and able to follow all study procedures and restrictions as determined by the investigators. The overall duration and detailed assessments ensure thorough monitoring of how well participants tolerate the adjunctive treatment over the course of one year.

Researchers are evaluating the effects of maridebart cafraglutide, given alongside standard care, in reducing heart failure events such as hospitalizations, urgent visits, cardiovascular deaths, and improving symptoms in people with heart failure who have preserved or mildly reduced ejection fraction and are obese. This is a global phase 3, multicenter trial with a two-part design including a double-blind period followed by an open-label extension. The first part will end once around 850 key events have been recorded. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study includes an initial randomized, double-blind phase and a later open-label extension where all participants may receive the active treatment. The trial is designed to monitor participants over time to assess the safety and effects of the treatment compared to placebo. During the trial, participants will undergo assessments including monitoring for cardiovascular events, heart failure symptoms, and laboratory tests such as NT-proBNP levels. Researchers will track time until the first occurrence of cardiovascular death or heart failure events over approximately 35 months. Safety evaluations, adherence to treatment, and ongoing health status will be followed throughout the study period.

Researchers are evaluating how well seltorexant works and its safety as an added treatment to antidepressants in adults and elderly participants who have major depressive disorder with insomnia symptoms (MDDIS). The study focuses on people who have not responded adequately to current antidepressant therapy with selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). This Phase 3 trial aims to assess the improvement of depressive symptoms and the maintenance effect of seltorexant compared to a placebo. Participants will receive either seltorexant or a matching placebo taken orally alongside their current antidepressant medication, which includes SSRIs or SNRIs. The study is divided into two parts: Part 1 evaluates changes in depression severity after 43 days, while Part 2 monitors the time to relapse for up to nearly three years in participants who achieved a stable response. Participants must continue their stable antidepressant dose during the study. During the study, participants will be assessed using the Montgomery-Asberg Depression Rating Scale to measure changes in depression symptoms and monitored for relapse over time. Safety and tolerability will also be evaluated throughout. The total participation includes an initial treatment phase and an extended maintenance phase, allowing researchers to understand both short-term and long-term effects of seltorexant as an adjunctive therapy.

Researchers are evaluating the effects of baxdrostat combined 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 systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.

Researchers are evaluating ITI-1284 as a monotherapy treatment for adults diagnosed with moderate to severe Generalized Anxiety Disorder (GAD) who have not responded adequately to previous GAD treatments. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study aims to assess the effectiveness, safety, and tolerability of ITI-1284 in this population. Participants must meet the DSM-5-TR criteria for GAD and have a significant level of anxiety as measured by clinical scales at screening and baseline. The study includes three periods: a screening period of up to 2 weeks to evaluate eligibility and allow washout from prohibited medications; a 6-week double-blind treatment period where about 570 participants are randomly assigned in equal groups to receive either ITI-1284 10 mg, ITI-1284 20 mg, or a matching placebo once daily via sublingual tablets; and a 1-week safety follow-up period after the last dose of the study drug. The treatments are administered once daily under blinded conditions. Participants will be involved in multiple assessments throughout the study, including evaluations of anxiety symptoms using the Hamilton Anxiety Rating Scale (HAM-A) at Week 6. Eligibility and safety are confirmed through structured interviews and clinical rating scales. Researchers will monitor treatment response, adverse events, and overall safety during the treatment and follow-up periods. The total participation duration includes screening, treatment, and safety follow-up visits.