Kawaguchi

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 to assess the treatments effects over a course of about 75 weeks, aiming to provide insights into managing weight in this population. Participants are randomly assigned to receive one of several doses of eloralintide or a placebo, all administered by weekly subcutaneous injections. The study involves a double-blind design, meaning neither participants nor researchers know which treatment is given. The treatment period lasts 64 weeks, during which body weight and other health measures are closely monitored. Participants will undergo regular assessments including measurements of body weight, fat mass, waist circumference, blood sugar control HbA1c, blood pressure, and other health indicators. Questionnaires about quality of life and eating behavior are also used. Safety and medication use changes are tracked throughout. Participation includes screening, treatment, and follow-up visits over the total duration of about 75 weeks.

Researchers are evaluating the combined use of vicadrostat and empagliflozin in adults with chronic heart failure who have a reduced left ventricular ejection fraction LVEF below 40%. Participants must have had chronic heart failure diagnosed at least three months before starting the study. The trial aims to find out if this combination helps people with symptomatic heart failure classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups, with an equal chance of receiving either vicadrostat plus empagliflozin tablets or placebo plus empagliflozin tablets. The study medicines are taken once daily for approximately six months up to about 3.5 years. During this time, participants may continue their usual heart failure treatments, excluding certain medications. The trial includes a double-blind design, meaning neither participants nor study staff know who receives the active drug or placebo. Throughout the study, participants visit the study site regularly, with the number of visits depending on how long they stay enrolled. Some visits may occur by phone. They answer questions about their well-being, and doctors monitor health status, record any heart failure worsening, hospitalizations, or deaths. The main outcome is the time until cardiovascular death, heart failure hospitalization, or urgent heart failure visit, which is compared between groups. Safety and side effects are also closely followed during the trial.

Researchers are evaluating the efficacy and safety of tozorakimab delivered under the skin in adults with uncontrolled asthma who are already using medium-to-high doses of inhaled corticosteroids. This phase IIb, double-blind, placebo-controlled study aims to find the optimal dosing range of tozorakimab in this population. The study is sponsored by AstraZeneca and uses a randomized, parallel design to compare different doses and placebo. Participants will receive subcutaneous injections of either tozorakimab at one of two dose levels or a placebo. The study arms include dosing with tozorakimab Dose 1, tozorakimab Dose 2, or placebo, administered under the skin. The treatment period lasts from 26 to 52 weeks, during which participants will be monitored for their asthma symptoms and lung function. Throughout the study, participants will undergo assessments including lung function tests such as forced expiratory volume in 1 second FEV1, asthma control questionnaires ACQ-6, quality of life questionnaires AQLQ12, and measurements of asthma exacerbations. Blood samples will be collected to measure drug levels and immune response. Safety and adherence will be closely monitored, and the primary outcome is the annualized rate of severe asthma exacerbations over the treatment period.

Researchers are evaluating the early use of empagliflozin, taken once daily by mouth, in patients hospitalized with acute heart failure who are at high risk of complications. This Phase 3, multicenter, randomized, double-blind trial compares empagliflozin to a placebo to assess its safety and effectiveness. The study is sponsored by Juntendo University and focuses on important outcomes like death, rehospitalization, worsening heart failure, and urine output within 90 days of treatment. Participants will be randomly assigned to receive either empagliflozin 10 mg once daily or a matching placebo. Treatment begins within 12 hours of hospital presentation. Both groups will be closely monitored during hospitalization and for up to 90 days after starting the study drug. The study uses a quadruple-blind design, meaning patients, caregivers, investigators, and assessors do not know which treatment is given. During the study, participants will undergo various assessments including monitoring of heart failure symptoms, urine output, blood tests for heart and kidney function, and quality of life questionnaires. Researchers will measure outcomes such as death rates, heart failure rehospitalizations, symptom changes, and kidney function over 90 days. Safety will be closely tracked throughout the study period. Total participation time varies but includes hospital stay and follow-up visits up to 90 days.

Researchers are investigating how well and safely Eloralintide LY3841136 works in adults who are overweight or obese and suffer from osteoarthritis pain in the knee. This study supports two independent phase 3 trials under a master protocol, focusing on improving knee osteoarthritis symptoms and body weight management in this population. Participants will receive either Eloralintide or a placebo by subcutaneous injection once weekly. The study follows a randomized, double-blind, parallel design with two separate arms for each independent study. Treatment and observation will last approximately 75 weeks, including the screening period. During the study, participants will undergo various assessments including measurements of body weight, knee pain using the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC pain subscale, blood pressure, physical function, inflammation markers, and metabolic parameters. Researchers will also track medication use, walk test performance, and other health-related quality of life measures over time to evaluate the effects and safety of Eloralintide.

This research aims to evaluate the effects of combining baxdrostat 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 a systolic blood pressure of at least 130 mmHg, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial focusing on preventing heart failure events and cardiovascular death. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those starting the baxdrostatdapagliflozin treatment may begin with a lower baxdrostat dose that can be increased if certain criteria are met. A run-in period with dapagliflozin alone for 4 to 6 weeks may occur for those not previously treated or treated less than 4 weeks with SGLT2 inhibitors. Treatment visits will occur at about 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months until study closure. Participants will undergo screening for eligibility within a 14-day period, with an optional pre-screening phase that does not require site visits or consent. During the study, regular assessments including monitoring for heart failure events and cardiovascular outcomes will be conducted. If participants stop the blinded treatment early, they may continue with open-label dapagliflozin unless specific discontinuation criteria apply. The study will continue until a predetermined number of cardiovascular events occur, with ongoing data collection and visits according to protocol.

Researchers are evaluating the effects of balcinrenone combined with dapagliflozin compared to dapagliflozin alone in patients who have chronic heart failure, impaired kidney function, and have recently experienced a heart failure event. This Phase III study is conducted internationally across about 700 sites and aims to assess how these treatments impact cardiovascular death and heart failure events. Participants will be randomly assigned to one of three groups balcinrenonedapagliflozin 15 mg10 mg plus placebo, balcinrenonedapagliflozin 40 mg10 mg plus placebo, or dapagliflozin 10 mg plus placebo. Each participant will take one capsule and one tablet daily. The study duration averages 22 months, including screening, about 20 months of blinded treatment, and a one-month follow-up with open-label dapagliflozin. During the study, participants will undergo assessments for heart failure events, hospitalizations, and cardiovascular death. Researchers will monitor these outcomes over about 38 months, including symptom scores and other health measures. Safety and treatment effects will be followed during the treatment and the one-month post-treatment period.