Bridgeport

Researchers are studying the use of ziltivekimab to treat people who have heart failure along with inflammation. The study aims to compare ziltivekimab with a placebo to understand its effects on heart failure and inflammation. This is a Phase 3 study sponsored by Novo Nordisk AS, focusing on patients with heart failure who have mildly reduced or preserved heart function and systemic inflammation. Participants will receive monthly injections of either ziltivekimab or a placebo, administered under the skin using either a pre-filled syringe or a pen-injector. The study medicine is given once a month for up to 4 years, alongside standard heart failure care. Two groups exist one receiving the active drug and the other receiving placebo injections, both continuing standard treatments. During the study, participants will attend up to 20 clinic visits and use a study app on their phones to record each injection and complete questionnaires. Researchers will monitor heart failure events such as hospitalizations and urgent visits, cardiovascular deaths, kidney function, inflammation markers, and quality of life measures over up to 48 months. Safety and disease progression will be closely followed throughout the study period.

Researchers are evaluating the efficacy and safety of eloralintide compared with placebo for reducing body weight in adults with overweight or obesity who also have type 2 diabetes. This Phase 3 study is designed as a randomized, double-blind, placebo-controlled trial sponsored by Eli Lilly and Company. The study aims to understand how well eloralintide works for weight loss and its effects on related health measures over a period of about 75 weeks. Participants will be randomly assigned to receive one of four doses of eloralintide or a placebo, all given as weekly subcutaneous injections. The treatment period lasts 64 weeks, during which participants will receive their assigned dose once weekly. The study compares different doses of eloralintide to placebo to assess its impact on body weight and other health outcomes. During the study, participants will undergo regular assessments including body weight, body fat, waist circumference, blood sugar control HbA1c, blood pressure, and various blood markers like triglycerides and insulin. Patient questionnaires will measure physical function and quality of life. Researchers will also monitor medication use and pharmacokinetics of eloralintide. Participation involves about 75 weeks including follow-up, with close monitoring for safety and treatment effects.

Researchers are evaluating the effectiveness and safety of eloralintide compared to a placebo in adults with persistent obesity or overweight. Participants may have type 2 diabetes or not and must be on a stable incretin therapy. This phase 3, randomized, double-blind study aims to understand how eloralintide works in this population and is sponsored by Eli Lilly and Company. The study lasts about 80 weeks in total. Participants receive eloralintide or placebo through weekly subcutaneous injections. There are four different doses of eloralintide being tested, and one group receives a placebo injection. The treatment period includes monitoring from the start until week 64, focusing on changes in body weight and various health measures. The study compares eloralintide with placebo to assess its impact on obesity and related health factors. Throughout the study, participants will have regular evaluations including body weight, waist circumference, blood pressure, glucose levels, and other metabolic and physical function assessments. Patient-reported outcomes such as quality of life and control of eating are also measured. Safety and medication use are monitored, along with blood tests for insulin, inflammation markers, and kidney function. The study includes pharmacokinetic assessments to understand drug levels. Overall participation is about 80 weeks, allowing for comprehensive monitoring and follow-up.

Researchers are evaluating the safety and effectiveness of Armour Thyroid compared to synthetic T4 in adults with primary hypothyroidism who have been stable on synthetic T4 treatment. The study will also assess how well patients tolerate switching from synthetic T4 to Armour Thyroid. This trial is a Phase 23, randomized, double-blind study sponsored by AbbVie to compare these two thyroid hormone replacement therapies. Participants will be randomly assigned to receive either Armour Thyroid or to alternate between Armour Thyroid and synthetic T4 for up to 81 weeks. The treatments are oral capsules or tablets taken daily, with doses carefully converted from their stable synthetic T4 dose. The study includes a dose-conversion period where dosage adjustments may be made to maintain appropriate thyroid hormone levels. During the study, participants will have regular blood tests to measure thyroid-stimulating hormone TSH levels, including at week 55 to see who achieves a target TSH response. Researchers will also monitor for any adverse events throughout the study, which lasts up to about 90 weeks. Dose adjustments and safety data will be tracked closely to understand treatment effects and tolerability over time.

Researchers are evaluating CD388, a long-acting antiviral treatment, to prevent symptomatic influenza infections in adults and adolescents at higher risk for influenza complications. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess how well CD388 works compared to placebo, as well as its safety and tolerability. Participants are randomly assigned to receive either a single dose of 450 mg CD388 or a matching placebo, both given by three subcutaneous injections. The study is conducted across multiple centers and includes participants aged 12 years and older. The trial compares the incidence of influenza-like illness starting from 7 days after dosing up to 24 weeks later. During the study, participants undergo screening tests including rapid antigen tests for influenza and COVID-19 before dosing. Researchers monitor participants for influenza-like illness, collect blood samples at several visits to measure CD388 levels and immune responses, and record any side effects. The overall participation lasts up to about 24 weeks, during which adherence to study procedures and safety are closely followed.

This research aims to evaluate whether the medicine vicadrostat, combined with empagliflozin, helps adults who have chronic heart failure with a weakened heart pumping function, defined by a left ventricular ejection fraction under 40. Participants must have been diagnosed with chronic heart failure for at least three months and have symptoms classified as New York Heart Association class II to IV. The study is a Phase III trial conducted by Boehringer Ingelheim to assess the efficacy and safety of these medicines compared to placebo with empagliflozin. Participants are randomly assigned to one of two groups one group receives vicadrostat plus empagliflozin tablets, and the other group receives placebo tablets plus empagliflozin. Tablets are taken once daily for a period ranging from about six months up to approximately three and a half years. Participants continue their usual heart failure treatments during the study. The trial includes regular study visits and phone contacts to monitor health and treatment effects. During the study, participants will have their health regularly checked, including monitoring for worsening heart failure symptoms, hospitalizations, or death related to heart failure. They will also complete questionnaires about their well-being. The main measure is the time until the first cardiovascular death, hospitalization for heart failure, or urgent heart failure visit. Researchers will compare these outcomes between treatment groups to see if the combined treatment affects these events. Safety and any unwanted effects will be closely tracked throughout the study period, which can last up to about 3.5 years.

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin can help adults aged 18 and older who have heart failure symptoms and a left ventricular ejection fraction LVEF of 40 or more. This phase III trial aims to assess the safety and effectiveness of this treatment compared to placebo with empagliflozin. Heart failure participants are classified as New York Heart Association NYHA class II-IV, and the study is sponsored by Boehringer Ingelheim. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once daily, while the other group takes placebo plus empagliflozin tablets once daily. The study is double-blind, meaning neither participants nor researchers know who is receiving which treatment. Participants remain in the trial as long as they benefit from and tolerate the treatment. Regular doctor visits and phone contacts monitor participants throughout the study. During the study, participants undergo regular health checks, including blood tests and questionnaires about well-being. Researchers track key health outcomes such as time to cardiovascular death, hospitalizations for heart failure, and quality of life measures using the Kansas City Cardiomyopathy Questionnaire. The study continues until sufficient data is collected, which may take up to 42 months. Safety and treatment effects are closely monitored throughout the trial.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are studying adults with type 2 diabetes, high blood pressure, and established cardiovascular disease who do not have a history of heart failure. The study aims to find out whether taking a medicine called vicadrostat together with empagliflozin can help reduce the risk of heart-related problems compared to taking a placebo with empagliflozin. This is a phase III trial sponsored by Boehringer Ingelheim evaluating the safety and effects of this combined treatment. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets, while the other group takes placebo tablets that look like vicadrostat plus empagliflozin. All participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. The study treatment is taken once daily for a period ranging from two and a half years up to four years and three months. During the study, participants visit the study site regularly where doctors collect health information and take blood samples. The doctors track any cardiovascular events and monitor participants for any side effects. The main outcome measured is the time until the first cardiovascular death or heart failure event over a period of up to 51 months. Several other heart and kidney-related outcomes are also evaluated throughout the study.

Researchers are evaluating the effects of KAI-9531, given as a weekly subcutaneous injection, in adults living with obesity or overweight who have weight-related health conditions but do not have diabetes. This Phase 3, randomized, double-blind, placebo-controlled study aims to compare changes in body weight between different doses of KAI-9531 and placebo over time. Participants will be randomly assigned to receive one of four different doses of KAI-9531 or a matching placebo once a week. The study treatment is administered by injection under the skin. The main comparison focuses on the percent change in body weight at week 76, with doses 3 and 4 compared specifically to placebo. Secondary measures include changes in waist circumference, blood pressure, cholesterol levels, quality of life scores related to weight, and other health indicators. During the study, participants will undergo regular assessments including weight measurements, blood tests, questionnaires about eating behavior and quality of life, and monitoring for any side effects. The study will track body weight changes, metabolic markers, and the presence of antibodies against the study drug up to week 80. The total participation time includes the treatment and follow-up periods lasting over a year and a half, allowing researchers to evaluate both efficacy and safety over the long term.