Evesham

Researchers are evaluating a new care strategy for people at increased risk of atherosclerotic cardiovascular disease ASCVD but without symptoms. The study compares a Cleerly Coronary Artery Disease CAD Staging System-based care approach against the usual risk factor-based care to see if it better reduces cardiovascular events. This pragmatic, randomized trial addresses the need for improved methods to identify and personalize treatment for asymptomatic individuals at risk due to age, diabetes, prediabetes, or metabolic syndrome. Participants are randomly assigned to one of two groups. The risk factor-based care group receives usual care managed by their providers, while a cardiology team monitors and supports guideline-based treatment without revealing certain imaging results during the study. The Cleerly stage-based care group gets personalized management from a remote cardiologist-led team using the Cleerly CAD Staging System, which includes imaging to assess coronary atherosclerosis and guides pharmacotherapy and education. Treatment intensity may increase if plaque worsens after 24 months. During the study, participants will have assessments to monitor heart health and treatment adherence over an average of 3.5 years. Researchers will measure cardiovascular events and other related health outcomes to compare the two care strategies. The study involves ongoing medication monitoring, lab tests, and feedback to optimize prevention, with the goal of improving personalized care for cardiovascular risk management.

Researchers are evaluating the effects of two oral drugs, ECC4703 and ECC0509, alone and in combination, on reducing liver fat in adults with presumed Metabolic Dysfunction-associated Steatohepatitis MASH. This phase 2a trial compares low and high doses of each drug and their combination with a placebo to assess changes in liver fat using MRI at 12 weeks. Participants are randomly assigned to one of several groups receiving either placebo, low or high doses of ECC4703, low or high doses of ECC0509, or a combination of high doses of both drugs. Each treatment is given as oral capsules. The main study period lasts 12 weeks during which participants take the assigned capsules and undergo evaluations. During the trial, participants will have multiple assessments including MRI scans to measure liver fat, blood tests to monitor liver enzymes and metabolic markers, and quality of life questionnaires. Drug levels in the blood will be measured at several time points. The study measures liver fat reduction primarily at 12 weeks and monitors safety and various biochemical markers throughout the period.

Researchers are studying the investigational drug LTX-001 to determine its safety and tolerability in adults diagnosed with schizophrenia who are experiencing a recent worsening of symptoms, known as an acute exacerbation. This early-phase trial also examines how the drug behaves in the body over time, how it affects schizophrenia symptoms, and changes in certain blood markers after taking LTX-001. Participants will be randomly assigned to receive different doses of LTX-001 or a placebo to compare effects. Eligible participants will stay overnight in a research unit for about five weeks, or up to 49 nights if they require up to 14 days to stop current antipsychotic medications before starting the study drug. They will take LTX-001 or placebo orally once or twice daily depending on the assigned dose. During the trial, participants will visit the study site three times for assessments including medical history review, physical and neurological exams, heart monitoring, blood and urine tests, psychiatric evaluations, and eye exams. Throughout the study and until Day 42, researchers will monitor participants for safety by tracking adverse events, lab tests, vital signs, heart activity, neurological exams, and suicidality risk. They will also assess drug levels in the body on specific days. After the treatment period, participants return for a follow-up visit one week later. Assessments include symptom scales, cognitive tests, and detailed psychiatric and physical evaluations to understand the drugs effects and safety profile.

Researchers are evaluating the safety and tolerability of LY4006895, a study drug, in both healthy volunteers and participants with early symptomatic Alzheimers Disease AD. The study includes two parts Part A involves single-ascending doses in healthy participants, and Part B involves multiple-ascending doses in participants with early AD. The study aims to better understand how LY4006895 behaves in the body, including how much enters the bloodstream and how long it takes to be eliminated. Participants in Part A will receive single intravenous IV doses of LY4006895 or a placebo, while those in Part B will receive multiple IV doses of LY4006895 or placebo. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the drug or placebo. The entire study lasts approximately 29 weeks for Part A and 61 weeks for Part B, including screening periods. During the study, participants will have blood tests to measure drug levels and monitor safety. Researchers will track any treatment-related side effects, serious adverse events, and study discontinuations. Participants with early AD must have study partners who will assist with visits and provide consent. The primary outcome is the number of participants experiencing adverse events up to 61 weeks. The study includes regular assessments to ensure participant safety and gather pharmacokinetic data throughout the trial.

Researchers are evaluating the study drug JNJ-42847922, also called seltorexant, in adults and older adults with major depressive disorder MDD, a mood disorder causing lasting sadness and loss of interest. The study aims to compare seltorexant with a placebo in improving depressive symptoms during a double-blind treatment phase and to assess the long-term safety and tolerability of seltorexant in an open-label phase. Participants will receive either seltorexant or a matching placebo tablet once daily for 42 days during the double-blind phase. Those who qualify for the open-label phase will then take seltorexant daily for up to six months. The treatments are oral tablets, and the study includes two main periods the initial 42-day double-blind phase and the subsequent long-term open-label phase. During the study, participants will have regular assessments including physical exams, vital signs, ECGs, and questionnaires on depression, sleep disturbance, suicidality, withdrawal symptoms, sexual functioning, body measurements, and laboratory tests. Researchers will measure changes in depression scores and monitor adverse events and safety indicators throughout both phases. The total participation can last up to about seven months including both treatment periods.

This research aims to study people with opioid use disorder OUD who often have difficulty falling asleep or staying asleep. The goal is to evaluate the safety and tolerability of suvorexant, a medication being studied for insomnia in this group. Researchers also want to find out if suvorexant helps people with OUD sleep longer compared to those taking a placebo, which looks like the medicine but contains no active drug. Participants in the study will be randomly assigned to receive either suvorexant or a matching placebo for about 8 weeks. Those taking suvorexant will start with 10 mg for the first three nights, then may increase to 20 mg nightly as decided by the study doctor. The study is designed as a double-blind, meaning neither participants nor researchers know who receives the medicine or placebo during the trial. During the study, participants will have their sleep time and wakefulness measured at the start and after 8 weeks. Researchers will monitor any side effects or serious events throughout the approximately 10-week period. Drug use will be assessed multiple times with urine tests. The study runs from October 2025 to June 2027, with safety and sleep outcomes carefully tracked to learn about suvorexants effects in people with OUD-related insomnia.

Schizophrenia is a serious psychiatric illness marked by significant disturbances in thinking, language, perception, and self-awareness. Researchers are evaluating the safety, effects on disease activity, and how the investigational drug emraclidine is processed in the body in adults with schizophrenia. This is a Phase 2 study designed to explore these aspects with careful monitoring. Participants are divided into two parts. In Part A, participants receive different increasing doses of oral emraclidine or placebo for 14 to 21 days. In Part B, participants receive oral emraclidine or placebo for up to 42 days. Following treatment, all participants enter a 30-day safety follow-up to monitor any lasting effects. During the study, participants will attend regular clinic visits for medical exams, blood tests, and questionnaires to check for side effects and disease changes. Researchers will measure adverse events, drug levels in the blood, and changes in schizophrenia symptoms using specific scales. The total participation time may be up to about 74 days including treatment and follow-up.

Researchers are conducting a phase 3, open-label extension study to assess the long-term safety and tolerability of KarXT for treating mania or mania with mixed features in adults with Bipolar-I disorder. The study focuses on evaluating how participants respond to KarXT over an extended period, emphasizing safety measurements such as adverse events and symptom changes. Participants will receive KarXT at specified doses over a treatment period lasting up to 54 weeks. This study includes participants previously involved in related placebo-controlled studies as well as new participants diagnosed with Bipolar-I disorder with manic symptoms. The treatment may be given alongside standard therapeutic doses of lithium, valproate, or lamotrigine as applicable. Throughout the study, participants will undergo regular assessments including monitoring of treatment emergent adverse events, serious adverse events, and psychiatric symptom scales like the Columbia-Suicide Severity Rating Scale, Young Mania Rating Scale, and others. Safety and tolerability will be closely tracked, with evaluations occurring up to week 54. The entire participation may last until the study end date in June 2028, ensuring comprehensive long-term follow-up.

Researchers are evaluating the efficacy, safety, and pharmacological effects of three different doses of KYN-5356 compared to a placebo in adults with cognitive impairment associated with schizophrenia. This Phase 2, randomized, double-blind, placebo-controlled study aims to investigate how these treatments affect cognitive function and brain activity. The study assesses pharmacokinetics and exploratory pharmacodynamics to understand how the drug behaves and impacts neurophysiological measures in the brain. Participants will be randomly assigned to one of four groups receiving either low, medium, or high doses of KYN-5356 or a placebo. Treatment involves taking oral tablets daily for 28 days while residing in the clinic. Participants are admitted three days before treatment begins and remain in the clinic for 32 days. Electrophysiological tests will be performed on a subset of participants to evaluate the drugs effect on brain function. During the study, participants will undergo frequent evaluations for efficacy, safety, and drug levels in the body. Safety assessments continue until discharge on Day 29, followed by a follow-up visit on Day 42. Researchers will measure cognitive function changes and monitor pharmacokinetic parameters such as maximum concentration and half-life. The total participation period includes the 32-day residential stay plus the follow-up visit, allowing close monitoring throughout.

Researchers are studying the effects of KarXT on bladder function and urological safety in adults diagnosed with schizophrenia according to DSM-5 criteria. This phase 4, open-label study aims to understand how KarXT influences urinary flow rates and residual urine volume over a 12-month period. The study is sponsored by Bristol-Myers Squibb and focuses on safety monitoring for participants with schizophrenia. Participants will receive KarXT, which consists of xanomeline and trospium chloride, administered at specified doses on designated days. The study lasts for 12 months, during which participants will be observed for changes in their urinary function and safety parameters related to the medication. No placebo or comparison group is mentioned, and the study is open-label, meaning both researchers and participants know the treatment being given. During the study, participants will undergo regular assessments including measurements of urinary flow and residual volume, urinalysis, symptom questionnaires, electrocardiograms, vital sign checks, and monitoring for adverse events including serious and special interest events. Researchers will also track any changes in suicidal thoughts or behaviors. The total participation duration is up to 12 months with ongoing safety and efficacy evaluations throughout this period.