Evesham

Researchers are studying a new oral weight loss medicine called MK-4082 in healthy adults who are overweight or obese. This Phase 1 study aims to find a safe dose and understand how the medicine behaves in the body over time. The focus is on whether people tolerate MK-4082 and its safety compared to a placebo. Participants will receive MK-4082 or a placebo in tablet form. The study uses multiple ascending doses to evaluate different levels of the medicine. The goal is to identify a dose that is safe and well tolerated for use in future research. During the study, researchers will monitor participants for any adverse events and whether anyone stops treatment due to side effects. The safety monitoring lasts up to about 98 days for adverse events and 84 days for treatment discontinuation. Participants' health and tolerability of the medication will be closely observed throughout the study period.

Researchers are evaluating a new approach to prevent cardiovascular events in patients at increased risk due to age and conditions like type 2 diabetes, prediabetes, or metabolic syndrome but without known symptomatic cardiovascular disease. The study compares a Cleerly Coronary Artery Disease (CAD) Staging System-based care strategy with standard risk factor-based care to see if the former can better reduce cardiovascular events. The Cleerly system uses imaging to visualize and quantify coronary artery disease and guides personalized treatment and education based on this assessment. The trial uses the Cleerly CAD Staging System device, which employs a proprietary algorithm to detect and stage coronary artery disease and generate a risk score to guide treatment decisions. Participants receive either this stage-based care or the usual care based on traditional risk factors. The study is prospective, randomized, and pragmatic, designed to follow patients over an average of 3.5 years to compare cardiovascular event outcomes between these two care approaches. Participants will be monitored through cardiovascular event tracking throughout the study period. Data collected includes imaging results, risk scores, and treatment adherence to evaluate the impact of the care strategies. The primary outcome is the comparison of cardiovascular event risk between the Cleerly stage-based care and risk factor-based care groups. The study also includes ongoing safety monitoring and personalized management by a cardiologist-led team via digital communication devices.

Researchers are evaluating the safety and tolerability of a drug called LY4006895 in a study involving healthy adults and patients with early symptomatic Alzheimer's Disease (AD). This Phase 1 trial includes two parts: Part A focuses on healthy participants receiving single-ascending doses, and Part B involves participants with early AD receiving multiple-ascending doses. The study aims to understand how LY4006895 behaves in the body by measuring blood levels and elimination over time. Participants in Part A will receive single intravenous doses of LY4006895 or placebo, while those in Part B will receive multiple intravenous doses following a schedule. The study lasts about 29 weeks for Part A and up to 61 weeks for Part B, including screening periods. Both parts monitor participants closely for any adverse effects and drug-related safety concerns. During the trial, participants will undergo various assessments including blood tests to track drug levels, cognitive evaluations, and safety monitoring. Up to two reliable study partners will support participants with early AD by attending visits and providing information. Researchers will record any treatment-emergent adverse events, serious adverse events, or discontinuations related to the study drug from baseline through study completion to evaluate safety and tolerability.

People with opioid use disorder (OUD) often experience difficulty falling asleep or staying asleep. This research aims to evaluate whether suvorexant can help improve sleep duration in people with OUD who also have insomnia. The study focuses on understanding the safety, tolerability, and effectiveness of suvorexant compared to a placebo, which looks like the study medicine but contains no active drug. Participants will be randomly assigned to receive either oral suvorexant tablets or placebo tablets. The study is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the effects of suvorexant and placebo on insomnia in people with OUD. Participants will maintain a regular bedtime between 8 PM and 1 AM throughout the study. During the approximately 8 to 10 week study period, researchers will assess changes in total sleep time from baseline to week 8. They will also monitor the number of participants experiencing any adverse events, serious adverse events, or discontinuation of study treatment due to adverse events. Safety and tolerability will be closely tracked to ensure participant well-being throughout the study.

Researchers are evaluating the effectiveness and safety of SP-624 compared to a placebo in adults aged 18 to 65 with moderate to severe Major Depressive Disorder (MDD). This Phase 2B study focuses on treating this condition and assesses changes in depression severity using the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to week 4. Participants receive either SP-624 or a placebo once daily. The SP-624 treatment consists of two capsules taken orally each day, providing a total dose of 20 mg. Those in the placebo group take two matching placebo capsules daily. The study is designed as a multi-center, double-blind, randomized, placebo-controlled trial. During the study, participants will be monitored for changes in depression severity through the MADRS assessment from the start of the study to week 4. Researchers will also evaluate safety and tolerability throughout the treatment period. The total study duration and specific follow-up details are not provided but include careful observation of participants' health and response to treatment.

Schizophrenia is a serious psychiatric disorder that affects thinking, language, perception, and the sense of self. This research aims to evaluate the safety, side effects, effects on disease symptoms, and how the investigational drug emraclidine is processed in adults with schizophrenia. The study is a Phase 2 clinical trial involving about 268 participants across approximately 32 sites in the United States. Participants are divided into two groups: Part A and Part B. In Part A, participants receive varying 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. After completing the treatment, all participants are followed for 30 days to monitor safety and effects after stopping the drug. During the study, participants will attend regular hospital or clinic visits for medical exams, blood tests, questionnaires, and monitoring for side effects. Researchers will measure multiple outcomes including adverse events, changes in schizophrenia symptoms using the Positive and Negative Syndrome Scale (PANSS), and how the drug and its metabolites move through the body. The total participation time includes treatment and a 30-day follow-up period.

Researchers are conducting a Phase 2, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of the oral drug ML-007C-MA in adult inpatients aged 18 to 64 years who have schizophrenia and are experiencing a sudden worsening of psychosis. The study aims to compare ML-007C-MA to a placebo in treating symptoms of schizophrenia that are not well controlled, with effectiveness measured by changes in the Positive and Negative Syndrome Scale (PANSS) total score. Participants will be assigned to one of three groups: one receiving ML-007C-MA twice daily at a dose of 210/3 mg, another receiving ML-007C-MA once daily at 330/6 mg, and a third group receiving a matched placebo. The treatment period lasts 5 weeks, during which participants remain in an inpatient setting. The study is designed to maintain blinding and closely monitor participants' response to the treatments. Throughout the study, participants will undergo evaluations at the start and end of treatment, including assessments using the PANSS to measure schizophrenia symptoms. Researchers will monitor safety, tolerability, and any side effects while participants remain hospitalized and under observation for the full study duration. The main measure of success is the change in PANSS total score from baseline to the end of treatment after 5 weeks.

Researchers are evaluating the long-term safety and tolerability of KarXT in treating mania or mania with mixed features in adults with Bipolar-I disorder. This phase 3, open-label extension study aims to better understand how KarXT performs over an extended period in this population. The study includes participants who either completed previous double-blind placebo-controlled studies or are newly diagnosed with Bipolar-I disorder experiencing manic symptoms. Participants receive KarXT at specified doses on certain days, with some also taking therapeutic doses of Lithium, Valproate, or Lamotrigine as part of their treatment. The study does not mention a placebo group during this extension, focusing instead on monitoring the long-term effects of KarXT alone or in combination with these established therapies. During the study, participants are monitored for adverse events up to week 54 to assess safety. Evaluations include psychiatric assessments using scales such as the Young Mania Rating Scale and CGI-BP score at screening and baseline. Researchers will track treatment-emergent adverse events and overall tolerability throughout the study duration, which lasts up to 54 weeks for each participant.

Researchers are evaluating ALN-4324 in overweight to obese adults, including healthy volunteers and patients with type 2 diabetes mellitus (T2DM). This two-part Phase 1/2 study aims to assess the safety, tolerability, and pharmacokinetics of single ascending doses in healthy volunteers and the efficacy, safety, tolerability, and pharmacodynamics of multiple doses in patients with T2DM. The trial focuses on understanding how ALN-4324 works and its effects in these groups. ALN-4324 and placebo are both given as subcutaneous injections. In Part A, single doses of ALN-4324 are administered to overweight to obese healthy volunteers to evaluate safety and drug behavior over up to 9 months. Part B involves multiple doses given to overweight to obese patients with T2DM, with monitoring up to 12 months to study effects on diabetes and overall safety. During the study, participants will undergo regular assessments to monitor safety and tolerability, including tracking any adverse events. The study also measures pharmacokinetics and pharmacodynamics to understand the drug's action in the body. Participants' body mass index, diabetes control, and medication use will be closely observed. The trial includes a placebo group for comparison and lasts up to 12 months depending on the study part.

Researchers are evaluating the safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.