Kardzhali

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 whether the medicine vicadrostat, combined with empagliflozin, helps adults with chronic heart failure (HF) who have a weakened heart pumping function, specifically a left ventricular ejection fraction (LVEF) below 40%. Eligible participants must have been diagnosed with chronic HF at least 3 months before joining. The study is a Phase III trial designed to compare the effects of vicadrostat plus empagliflozin against placebo plus empagliflozin in people with symptomatic chronic HF classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups. One group takes tablets containing vicadrostat and empagliflozin, while the other group takes placebo tablets that look like vicadrostat along with empagliflozin. Tablets are taken once daily for a period ranging from about 6 months up to about 3.5 years. Participants continue their usual heart failure treatments during the study. The study is double-blind, meaning neither the participants nor the study staff know who is receiving which treatment. During the study, participants regularly visit the study site or may have phone contacts for follow-up. They answer questions about their health and well-being. Doctors monitor and record any worsening of heart failure symptoms, hospital visits due to heart failure, or deaths. They also check participants' overall health and note any side effects. The main outcome measured is the time until a participant experiences cardiovascular death, hospitalization for heart failure, or an urgent heart failure visit, over up to 43 months of follow-up.

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

Researchers are evaluating ACP-204, a drug that blocks a specific serotonin receptor, in adults aged 55 to 95 with Alzheimer's Disease Psychosis (ADP). The study is designed as a master protocol with three independent, multicenter, randomized, double-blind, placebo-controlled trials. The trials include Phase 2 and Phase 3 studies to assess the drug's effectiveness and safety in treating psychotic symptoms associated with ADP. The research involves three substudies. Substudy 1 (Phase 2) tests two doses of ACP-204, 30 mg and 60 mg, against a placebo to evaluate dose response. Substudies 2A and 2B (both Phase 3) will independently confirm the effects of either both doses or a single dose from Part 1 compared to placebo. Each substudy includes a screening period of up to 49 days, a six-week double-blind treatment phase, and a 30-day safety follow-up for those not continuing into an open-label extension. Vital status follow-up is conducted for participants who end the study early. Participants will receive regular assessments, including evaluations of psychotic symptoms using the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales from baseline to Week 6. Other study involvement includes brain imaging scans and biomarker tests to confirm Alzheimer's disease diagnosis, cognitive testing, and monitoring of safety and vital status throughout the study periods. Stable living arrangements and support from a caregiver are required to complete all study visits.

Researchers are evaluating the long-term safety and tolerability of adjunctive KarXT, a combination of xanomeline and trospium chloride, in adults aged 18 to 65 with schizophrenia who did not have sufficient symptom control with their current antipsychotic medications. This Phase 3, open-label extension study involves participants who previously completed the treatment period of the ARISE study (KAR-012). The goal is to monitor how well patients tolerate KarXT over an extended period while assessing related safety concerns. Participants receive fixed doses of KarXT capsules twice daily, with doses ranging from 50 mg/20 mg up to 125 mg/30 mg. The study lasts for 52 weeks as an outpatient program. This open-label extension allows researchers to observe the effects and safety of KarXT when added to stable antipsychotic treatment under real-world conditions. During the study, researchers closely monitor participants for any treatment-emergent adverse events from the initial dose through a safety follow-up visit at 54 weeks or early termination. Participants will undergo regular assessments, including clinical evaluations and reports from reliable caregivers who assist with study activities. The study ensures participants maintain stable living situations and continue their background antipsychotic medications throughout the study period.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Researchers are studying adults with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (SHTG) who have completed previous related studies. The main goal is to evaluate the long-term safety and effectiveness of plozasiran, a drug given by injection, in these adults. Participants must meet specific health criteria, including controlled blood sugar levels and prior study completion, to join this open-label phase 3 extension trial. Eligible participants will receive plozasiran injections under the skin about every three months for two years. They will be advised to continue a low-fat diet throughout the study. This study includes adults from various countries who have met all previous study requirements or were prevented from randomization to avoid over-enrollment but still meet eligibility. Special criteria apply for some participants from earlier studies regarding their triglyceride levels and history of pancreatitis. During the study, participants will be monitored for any treatment-related side effects from the first dose through month 24. Researchers will assess safety by tracking adverse events and other health measures. Participants will also be counseled on medication adherence and diet, with ongoing evaluations to ensure their well-being throughout the two-year treatment period.

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.

Researchers are evaluating lumateperone as an additional treatment for adults aged 18 to 65 with major depressive disorder (MDD) who have not responded adequately to current antidepressant therapy. This phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess the effectiveness and safety of lumateperone in patients diagnosed according to the DSM-5 criteria, including those with psychotic features. Participants must have moderate to severe depression and an ongoing major depressive episode lasting between 12 weeks and 18 months. Participants will be randomly assigned to receive either lumateperone 42 mg capsules or matching placebo capsules once daily during a six-week double-blind treatment period. Before treatment, there is a screening period of up to two weeks to confirm eligibility. After the treatment phase, there is a one-week safety follow-up visit to monitor participants after completing the study medication. Throughout the study, patients will be assessed using depression rating scales including the Montgomery-Asberg Depression Rating Scale (MADRS). Other evaluations include psychiatric interviews, symptom questionnaires, and safety monitoring for suicidal thoughts or behaviors. The study tracks changes in depression severity and safety outcomes from screening through treatment and follow-up, totaling approximately nine weeks of participation.

This research aims to evaluate the long-term safety, tolerability, and effectiveness of NMRA-335140 in adults with major depressive disorder (MDD). It involves participants who completed earlier Phase 3 studies of NMRA-335140 for MDD and met specific eligibility and consent requirements. The study provides an opportunity to extend treatment and monitor outcomes over a longer period. Participants will receive NMRA-335140 at a dose of 80 mg taken orally once daily for a 52-week treatment period. This open-label extension allows continued assessment beyond the initial parent studies, focusing on sustained safety and effectiveness of the medication. Throughout the 52 weeks, researchers will monitor participants for treatment emergent adverse events and use validated clinical scales to assess safety and tolerability. The study's total duration for participants is up to 54 weeks, including safety assessments. Data collected will help understand the long-term effects of NMRA-335140 in managing MDD.