Ypsilanti

Researchers are studying adults with confirmed Primary Biliary Cholangitis (PBC) and cirrhosis, a scarring of the liver caused by damage to bile ducts. PBC is a slowly progressing disease that causes bile acid buildup and further liver damage, which can lead to cirrhosis. This study aims to evaluate if elafibranor, a daily medication, can prevent worsening clinical outcomes such as the need for liver transplant or death, compared to a placebo. It also looks at the safety of long-term elafibranor use and its effect on symptoms like itching and tiredness. Participants will take either an 80 mg tablet of elafibranor or a matching placebo once daily for up to 3.5 years in a double-blind setup, meaning neither the participants nor researchers know who receives which treatment. This long-term treatment period is designed to monitor the drug's impact over time. The study includes two groups: one receiving elafibranor and the other receiving placebo, with treatment lasting up to approximately 42 months. During the study, participants will be regularly assessed from the start until 4 weeks after treatment ends, with a maximum involvement of 3.5 years. Researchers will measure event-free survival, tracking if participants avoid clinical events indicating disease worsening. Safety monitoring will include tracking side effects and overall health, while symptom impact will be evaluated. Participants will provide informed consent and follow the study protocol throughout this extended observation period.

Researchers are conducting a Phase 2, multicenter platform study to evaluate the safety and effectiveness of several investigational treatments for adults with moderately to severely active Inflammatory Bowel Disease (IBD), including Crohn's Disease and Ulcerative Colitis. The study focuses on assessing multiple experimental oral or injectable therapies to better understand their effects on these conditions. Participants will receive one of the study drugs, MT-501 or MT-201, as part of this evaluation. The study aims to gather data on how these treatments perform in terms of safety, how the body processes them (pharmacokinetics), and their biological effects (pharmacodynamics). Treatment effects will be measured over a period of up to 13 weeks. During the study, participants will be monitored for any side effects, serious adverse events, and laboratory test changes. Researchers will also assess the participants' clinical remission status and improvements seen through endoscopic evaluations at 12 to 13 weeks. The total involvement duration includes screening and treatment periods, with careful tracking of outcomes and safety throughout.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

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 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 long-term safety and effectiveness of the FDA-approved VARIPULSE catheter system in treating people who have symptomatic paroxysmal atrial fibrillation (PAF). This condition involves irregular heart rhythms that start and stop suddenly. The study focuses on how well this treatment manages atrial fibrillation over time using a specialized catheter system. The treatment involves pulsed field ablation using the VARIPULSE catheter combined with the TRUPULSE generator. This device is designed to perform pulmonary vein isolation (PVI) to help control atrial fibrillation symptoms. Participants will undergo this catheter-based procedure as the main intervention during the study. Participants will be monitored closely after the procedure, with researchers tracking early adverse events within 7 days and occurrences of atrial tachyarrhythmia episodes from day 61 up to 1095 days post-procedure. The study includes follow-up testing and assessments to measure safety and effectiveness over an extended period. Participants must comply with all study requirements during this time to help ensure accurate results.

Researchers are evaluating the effectiveness of pembrolizumab combined with sacituzumab govitecan-hziy compared to the standard chemotherapy treatments in patients with locally advanced or metastatic urothelial cancer. This Phase III trial focuses on cancers that have spread to nearby tissues, lymph nodes, or other parts of the body. The study aims to compare overall survival and other outcomes such as progression-free survival, response rates, clinical benefits, duration of response, and treatment toxicity between the two treatment approaches. Quality of life and fatigue are also assessed as secondary measures. Participants are randomly assigned to one of two treatment groups. One group receives standard of care chemotherapy, which may include carboplatin or cisplatin combined with gemcitabine, or alternatively docetaxel or paclitaxel, administered intravenously in cycles every 21 days for up to six cycles, unless the disease progresses or side effects become unacceptable. The other group receives sacituzumab govitecan-hziy intravenously on days 1 and 8, along with pembrolizumab intravenously on day 1 of each 21-day cycle, continuing for up to 35 cycles or two years, unless there is disease progression or unacceptable toxicity. Throughout the study, participants undergo regular blood sample collections and imaging scans using computed tomography or magnetic resonance imaging to monitor their condition. Quality of life questionnaires are also completed to assess symptoms and fatigue over time. After treatment ends, patients are followed up 30 days later and then annually for up to five years to evaluate long-term outcomes and safety. The main outcome measured is overall survival from the time of randomization up to five years.

Researchers are investigating the safety and effectiveness of efruxifermin in people with non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis (stage 2 or 3). This Phase 3 study is randomized, double-blind, and placebo-controlled, enrolling a total of 1650 participants in two groups to evaluate treatment outcomes. Participants will receive either efruxifermin or a placebo by subcutaneous injection. The study involves two cohorts, with Cohort 1 including patients who have biopsy-confirmed NASH or MASH and specific liver fibrosis and activity scores. The treatment period and detailed dosing schedules are not provided but the study compares the effects of the active drug against placebo. During the study, participants will be monitored for improvement in liver disease status, including resolution of NASH/MASH and at least a one-stage improvement in liver fibrosis after 52 weeks for Cohort 1. Long-term outcomes such as event-free survival will be observed over 240 weeks. Safety and efficacy assessments will be conducted throughout the study period, including evaluations of liver histology and metabolic health.

This research aims to evaluate the effectiveness and safety of two different dose schedules of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis (MASH) who have liver fibrosis at stage F2 or F3. This phase 3 study focuses on improving liver fibrosis and steatohepatitis in this patient group, which involves chronic liver disease associated with metabolic dysfunction. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study compares two doses of pegozafermin to assess their impact on liver fibrosis and steatohepatitis. The treatment period lasts up to 52 weeks, with outcomes measured at this time point. During the study, participants will be monitored for improvements in liver fibrosis and resolution of steatohepatitis without worsening fibrosis by week 52. Researchers will also track the time until any disease progression occurs, up to 5 years. Throughout the trial, safety and efficacy will be carefully assessed through clinical evaluations and laboratory tests to ensure participant well-being.

Researchers are evaluating the safety and effectiveness of vonoprazan 20 mg taken once daily compared to a placebo in adults with eosinophilic esophagitis (EoE). The main goal is to see how many participants achieve a peak eosinophil count of less than 15 eosinophils per high-power field in the esophagus after 12 weeks of treatment. This is a Phase 2, randomized, double-blind study involving adult participants with EoE. Participants will receive either vonoprazan 20 mg tablets or matching placebo tablets taken orally once daily. The study includes a primary treatment period of 12 weeks, with an additional evaluation of vonoprazan safety and efficacy up to 24 weeks. Treatment is closely monitored to assess the effects on esophageal inflammation. During the study, participants will be monitored through endoscopic biopsies to measure eosinophil counts in the esophagus. They will also complete electronic diaries to document symptoms like dysphagia. Safety assessments and other clinical evaluations will be conducted throughout the study. The primary outcome is the number of participants achieving the target eosinophil count at week 12, with ongoing monitoring to ensure safety and compliance.