Worcester

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.

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 effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

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 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.

This research aims to evaluate the safety, immune response, and effectiveness of a new live attenuated tuberculosis vaccine called MTBVAC in newborns who are HIV-uninfected but born to both HIV-infected and uninfected mothers. This Phase 3 trial compares MTBVAC to the standard BCG vaccine in regions of Sub-Saharan Africa with high tuberculosis rates. The study builds on previous collaborations in Europe and Africa and seeks to enhance laboratory capabilities to better understand immune protection from TB vaccines and support future vaccine development efforts. Participants will receive either the MTBVAC vaccine or the standard BCG vaccine shortly after birth. MTBVAC is developed from an attenuated M. tuberculosis strain with specific genetic deletions designed to improve immune protection compared to BCG, which is an older vaccine made from a weakened M. bovis strain. The study involves newborns vaccinated within seven days of birth and follows them for a minimum of 24 months up to a maximum of 80 months or until the study ends in South Africa. Throughout the trial, newborns and their caregivers will attend follow-up visits for health assessments, medical record reviews, and laboratory testing to monitor safety and immune responses. Researchers will measure the incidence of tuberculosis disease as the primary outcome, along with vaccine safety and immune effects. The study also includes careful tracking of maternal HIV status and infant health to ensure accurate evaluation of the vaccine's performance in this population.

Researchers are evaluating the safety and immune response of the MTBVAC vaccine in adolescents and adults aged 12 to 55 years living with or without HIV in South Africa. The study focuses on comparing MTBVAC to the BCG vaccine and is conducted as a Phase 2a clinical trial. Participants are grouped based on HIV status, CD4+ T cell counts, and IGRA status to better understand the vaccine's effects in different subpopulations. The study is divided into two parts, with Part A including two cohorts and Part B having one cohort, each with four groups. Participants are randomized to receive either a single 0.1 mL injection of MTBVAC or BCG vaccine intradermally. Enrollment in the third cohort will begin only if safety criteria are met for the first two cohorts. All participants receive one dose and are followed for 48 weeks to monitor outcomes. Participants will undergo various assessments throughout the study, including monitoring for adverse events up to 48 weeks and evaluating immune cell responses at baseline and weeks 4 and 10. Researchers will track solicited and unsolicited adverse events, serious adverse events, and Grade 3 or higher adverse events. Safety, immune responses, and overall health will be carefully observed through clinical exams, laboratory tests, and questionnaires during the study period.

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 studying how a visual Informed Consent Form (ICF) using cartoons, graphics, and easy-to-understand text compares to a traditional text-only ICF in helping women better understand clinical trial information. This study focuses on women considering joining a nutrition trial for their infants in South Africa. The goal is to see if the visual ICF improves participants' understanding of trial risks, benefits, and procedures, leading to more meaningful consent. Women who agree to join this sub-study will be randomly assigned to receive either the visual ICF or the text-only ICF. After deciding whether to participate in the larger infant nutrition trial, women will be interviewed about their knowledge of the trial content, including the study goal, risks, benefits, and randomization. These interviews use true/false/uncertain and rating scale questions. The same questions will be asked again 8 weeks later during a follow-up visit to check knowledge retention and feelings about the decision. Additionally, a group of women not eligible for the larger trial will be asked their opinions about the visual ICF in a separate qualitative interview. Participants will be involved in interviews immediately after the consent process and 8 weeks later. Researchers will collect both numerical and descriptive data to measure understanding, decision conflict, self-rated understanding, satisfaction, decision regret, and trust in the study team. The study aims to provide insights to improve informed consent processes in clinical trials, especially for perinatal HIV research.

Researchers are evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on cardiovascular death and heart failure events in patients with chronic heart failure and impaired kidney function who recently experienced a heart failure event. This is a Phase III, international, randomized, double-blind, parallel-group, active-controlled study involving approximately 700 sites in about 40 countries. Participants will be randomly assigned in a 1:1:1 ratio to receive one of three treatments once daily: a capsule of balcinrenone/dapagliflozin 15 mg/10 mg with a placebo tablet, a capsule of balcinrenone/dapagliflozin 40 mg/10 mg with a placebo tablet, or a dapagliflozin 10 mg tablet with a placebo capsule. The study is event-driven, with an estimated average duration of 22 months that includes a screening period, a 20-month blinded treatment phase, and a one-month follow-up on open-label dapagliflozin. During the study, participants will be monitored for the time to first occurrence of cardiovascular death, heart failure hospitalization, or heart failure events without hospitalization over approximately 38 months. Assessments include clinical evaluations, laboratory tests, and safety monitoring throughout the study and follow-up period to track treatment effects and patient outcomes.