Takasaki

Researchers are evaluating whether retatrutide and tirzepatide can prevent major adverse liver outcomes in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized controlled trial aims to assess these treatments compared to placebo in about 4,500 adults over approximately 224 weeks. The study is sponsored by Eli Lilly and Company and focuses on liver disease progression and related health measures. Participants will be randomly assigned to receive retatrutide, tirzepatide, or placebo, all administered by subcutaneous injection. The trial includes two placebo groups corresponding to each experimental drug. After completing the main study, eligible participants may join a 2-year extension where all will receive either retatrutide or tirzepatide regardless of their initial assignment. During the study, participants may attend around 25 to 30 clinic visits for health monitoring, study procedures, and assessments of liver function and disease status. Researchers will measure the time to major adverse liver outcomes, changes in liver fibrosis scores, liver stiffness, liver fat content, liver enzyme levels, body weight, and cardiovascular events. Monitoring will continue from baseline through study completion, with detailed evaluations at multiple timepoints including week 104.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

This research aims to evaluate the antiviral effects of S-337395 compared with a placebo in adults who are not hospitalized but have respiratory syncytial virus RSV infection and are at high risk of progressing to severe disease. Participants must start treatment within 72 hours of showing RSV symptoms. The study is a Phase 2b trial and involves adults with specific risk factors such as older age and chronic lung or cardiovascular disease. Participants will be randomly assigned to receive either a high dose or low dose of S-337395, or a matching placebo. The treatment is given orally twice daily for up to 5 days. The study is double-blind, meaning neither participants nor researchers know which treatment is being administered during the trial. Throughout the study, participants will be monitored closely with assessments including nasal swabs to measure RSV RNA levels at several time points up to day 6. Researchers will also track symptoms using questionnaires and record any side effects up to 28 days. Blood samples will be collected to measure drug levels, and safety will be monitored throughout the study, which runs until December 2026.

Researchers are evaluating the safety and effects of the medicine ritlecitinib for adults with chronic spontaneous urticaria CSU that is not well controlled by antihistamines. CSU causes itchy hives and swelling in the skin and fatty tissue without a clear cause. This phase 2 study aims to compare two oral doses of ritlecitinib, 50 mg and 100 mg, against a placebo to learn how well they work and their safety profiles. Participants will be randomly assigned to one of three groups taking 50 mg ritlecitinib, 100 mg ritlecitinib, or a placebo, each taken once daily by mouth for 12 weeks Period A. After this, those on ritlecitinib continue their doses for another 12 weeks Period B, while those initially on placebo switch to 100 mg ritlecitinib for the same duration. Placebo capsules matching the active doses will be given to maintain study blinding. Participants will be involved in the study for about 8 months and will visit the study site up to 9 times. During visits, they will have physical exams, hearing tests, blood tests, chest X-rays, and ECGs. They will also complete daily questionnaires about their symptoms using an electronic diary. The main outcome measured is the change in their urticaria activity score after 12 weeks, along with monitoring for any side effects or adverse events throughout the study.

Researchers are evaluating the safety and effectiveness of a study medicine called PF-08049820 for treating atopic dermatitis AD, also known as eczema. This condition often causes severe itching and rashes on the skin. The study focuses on adults aged 18 to 64 who have moderate to severe AD confirmed at least six months prior and who do not currently have a suitable prescribed medicine for their condition. Participants in the study will take either PF-08049820 tablets or placebo tablets daily by mouth for 12 weeks during two stages of the trial. The placebo tablets look like the study medicine but do not contain any active drug. Clinic visits occur on Day 1, Weeks 1, 2, 4, 6, 8, and 12, with a follow-up visit at Week 16. At these visits, participants will have their health and skin condition evaluated, including blood and urine tests and questionnaires about their symptoms and quality of life. Throughout the study, researchers will compare the experiences of those receiving PF-08049820 with those receiving placebo to determine safety and effectiveness. They will measure changes in the severity of eczema using tools like the Eczema Area and Severity Index EASI and other assessments of itching and skin appearance. Safety will be monitored by tracking any adverse events and changes in laboratory tests. Total participation lasts about 16 weeks from the first dose through follow-up.

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 combination of capivasertib with CDK46 inhibitors and fulvestrant in adults with hormone receptor-positive and HER2-negative locally advanced or metastatic breast cancer. This Phase IbIII study aims to determine the safe dose for the combination treatment in the initial Phase Ib part and then compare its effectiveness and safety to standard treatment in the Phase III part in participants who have not received prior endocrine therapy in the advanced setting. In the Phase Ib portion, participants receive capivasertib combined with one of the CDK46 inhibitorspalbociclib, ribociclib, or abemacicliband fulvestrant to establish recommended doses. In the Phase III part, participants are randomly assigned to receive either capivasertib plus fulvestrant with a chosen CDK46 inhibitor palbociclib or ribociclib or fulvestrant with a CDK46 inhibitor alone. Treatments are given in 28-day cycles with specific dosing schedules for each drug, including oral doses of capivasertib and CDK46 inhibitors and injections of fulvestrant. Participants undergo screening and regular monitoring throughout the study, including assessments of treatment side effects, tumor progression, and blood samples for pharmacokinetics and biomarker analysis. The primary outcomes include dose-limiting toxicities and adverse events in Phase Ib and progression-free survival in Phase III, with follow-up lasting up to several years to evaluate overall survival, response rates, physical functioning, and quality of life.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are evaluating the effects of early treatment with finerenone in patients hospitalized with acute heart failure AHF who have a left ventricular ejection fraction of 40% or more. This phase 4, randomized, double-blind, placebo-controlled trial aims to determine whether starting finerenone during the early phase of hospitalization improves outcomes compared to placebo. Participants are randomly assigned to receive either finerenone or a matching placebo orally. The dosing of finerenone depends on kidney function for those with an eGFR of 60 mLmin1.73 m or less, dosing starts at 10 mg once daily up to 20 mg for those with an eGFR above 60 mLmin1.73 m, dosing starts at 20 mg once daily up to 40 mg. The study treatment is initiated within 36 hours of hospital admission, with randomization occurring within 24 hours. During the study, participants are monitored up to 12 weeks for a composite outcome of death and worsening heart failure, with assessments including heart failure rehospitalization, changes in heart failure symptoms, and biomarker levels such as NT-proBNP. Additional evaluations cover urine output, dyspnea, atrial fibrillation symptoms, and quality of life via questionnaires. Safety and efficacy are closely observed throughout the treatment and follow-up period.