Hachioji

Researchers are evaluating the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of LY3962681 in both healthy volunteers and patients with Parkinson's disease. This study includes a Single Ascending Dose (SAD) phase with healthy volunteers and a Multiple Ascending Dose (MAD) phase involving Parkinson's patients to better understand the effects of the drug administered into spinal fluid. The study is a Phase 1 trial designed to gather important safety and dosage information for LY3962681 compared to a placebo (artificial cerebrospinal fluid). The study consists of two parts: the SAD study where healthy volunteers receive a single dose of LY3962681 or placebo via intrathecal (IT) injection, and the MAD study where Parkinson's patients receive two doses of LY3962681 or placebo spaced 12 to 24 weeks apart, also by IT injection. The treatment period lasts one day in the SAD study and two days in the MAD study. Follow-up for both parts extends up to 52 weeks after the last dose to monitor participants. Participants will undergo medical evaluations, including cognitive assessments and specific Parkinson's disease diagnostic tests for patients. The study monitors serious and treatment-emergent adverse events, as well as discontinuations due to side effects, for up to 76 weeks. Throughout the study, researchers will closely observe participants' safety, tolerability, and the body's processing of the drug to determine its effects over time.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). The study aims to assess how well duvakitug maintains clinical remission compared to a placebo over time. Participants will receive either duvakitug or placebo administered by subcutaneous injection during a 40-week pivotal maintenance period. Following this, eligible participants may join a 240-week open-label extension phase where they can continue receiving treatment. Participants who do not join the extension will complete a 45-day follow-up visit. The study includes up to 32 on-site visits, with 21 visits during the maintenance phase and 11 visits during the extension phase. Throughout the study, participants will be monitored for clinical remission using the modified Mayo Score by week 40. Safety and efficacy will be assessed regularly during office visits. The total study duration may last up to 286 weeks, including treatment, extension, and follow-up periods, ensuring thorough evaluation of long-term outcomes and safety of duvakitug in UC management.

Researchers are assessing the side effects and behavior of LY3971297, an injectable drug given under the skin, in healthy adults and obese adults with high blood pressure. The study aims to understand how much of the drug enters the bloodstream and how long it stays in the body. This research includes seven parts, with study durations of about 60 days for Parts A and F, and approximately 90 days for Parts B, C, D, E, and G. Participants will receive LY3971297 or a placebo either by under-the-skin injection or intravenously. Different groups will receive varying doses of the drug across the seven parts of the study. Each part includes specific dosing schedules and monitoring periods. Some parts allow stable background treatments for related conditions like hypertension and diabetes. The trial also includes participants with decreased kidney function in Part G. During the study, participants will undergo blood tests to check drug levels and adverse effects. Researchers will monitor side effects from the day of dosing up to 29 or 57 days depending on the part. Safety assessments include checking for treatment-emergent and serious adverse events possibly related to the drug. The study also measures pharmacokinetics such as drug concentration over time. Participants will be evaluated through medical history, physical exams, and vital sign monitoring throughout their involvement.

Researchers are evaluating the safety, tolerability, and how the body processes the drug LY4006896 when given intravenously compared to a placebo in both healthy adults and adults with Parkinson's disease. This Phase 1 study aims to generate evidence on these aspects to better understand the effects of LY4006896 in these two groups. Participants include healthy individuals and those diagnosed with Parkinson's disease, reflecting a broad study population. Participants with Parkinson's disease undergo a screening period of up to 120 days and receive four doses of the study drug or placebo. Healthy participants have a shorter screening period of up to 35 days and receive a single dose. The treatment and follow-up last up to 61 weeks for Parkinson's disease participants and 48 weeks for healthy participants. Both LY4006896 and placebo are administered intravenously during the study. During the study, participants will have regular assessments including evaluations for any serious or treatment-emergent adverse events up to 48 weeks for healthy participants and 61 weeks for those with Parkinson's disease. Researchers will monitor safety, tolerability, and drug effects through blood sampling and clinical evaluations over a total duration of up to 78 weeks for Parkinson's disease participants and 53 weeks for healthy participants. Cognitive function and treatment stability are also monitored in Parkinson's disease participants.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 who have mild to severe Alzheimer's Disease (AD) accompanied by moderate to severe psychosis related to AD. This phase 3 study aims to better understand how KarXT compares to a placebo in treating the psychotic symptoms associated with Alzheimer's Disease. Participants must have documented AD diagnosis and a history of psychotic symptoms lasting at least two months prior to starting the study. Participants will receive either KarXT or a placebo, with specified doses given on designated days. The study is designed as a randomized, double-blind, placebo-controlled trial with parallel groups to assess the treatment's effects. Details about dosing schedules and administration are planned but not specified here. During the study, researchers will measure changes from baseline in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score up to week 14 to evaluate the impact on psychosis symptoms. Participants will undergo brain imaging (MRI or CT) if not already done within the past five years to rule out other conditions, and safety monitoring including laboratory tests will be conducted. The total participation duration covers screening through at least 14 weeks of treatment and assessment.

Researchers are evaluating the effectiveness and safety of KarXT in Japanese adults aged 18 to 65 who are experiencing acute psychotic episodes due to schizophrenia. The study focuses on adults diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) and confirmed by a psychiatric interview. Participants must have a specific range of symptom severity measured by the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity (CGI-S) scale. Participants are randomly assigned to receive either KarXT or a placebo during a 5-week double-blind phase where neither the participants nor the researchers know which treatment is given. After this, there is a 52-week open-label extension where all participants receive KarXT. The doses are specified and administered on set days throughout the study. Throughout the study, researchers monitor changes in schizophrenia symptoms using the PANSS score at week 5 and track any treatment-emergent adverse events up to week 52 during the open-label extension. The study involves regular assessments to ensure safety and effectiveness over both the short and long term, with total participation lasting up to 57 weeks.

Researchers are evaluating the safety and effects of a study medicine called PF-07275315 for treating adults with moderate-to-severe asthma that is not well controlled. This condition makes breathing difficult and affects quality of life. The study is a Phase 2, randomized, double-blind, placebo-controlled trial aiming to determine if PF-07275315 is safe and effective for this group. Participants will receive either PF-07275315 or a placebo through multiple subcutaneous injections administered in the clinic over 12 weeks. The study compares these two groups to assess treatment responses. The trial includes a total of 9 clinic visits and lasts about 7.5 months for each participant. During the study, participants will undergo various assessments including lung function tests to measure forced expiratory volume in 1 second (FEV1), safety monitoring through adverse event tracking, laboratory tests, vital sign checks, and electrocardiograms. These evaluations occur from baseline through 24 weeks to observe changes and treatment tolerability.

Researchers are evaluating the early use of a once-daily oral drug called empagliflozin 10 mg in patients hospitalized with acute heart failure (AHF) who are at high risk for serious complications. This multicenter, randomized, double-blind, placebo-controlled Phase 3 trial aims to assess the efficacy and safety of empagliflozin compared to a matching placebo in this patient group. The trial focuses on patients requiring intravenous diuretic therapy and exhibiting specific clinical signs and biomarker levels related to heart failure severity. Participants are randomly assigned to receive either empagliflozin 10 mg once daily or a placebo shortly after hospital admission. Treatment begins within 12 hours of hospital presentation and continues during the hospitalization period. The study excludes patients with very low kidney function, recent use of similar drugs, certain heart conditions, and other specific medical issues to ensure safety and clear evaluation of the drug's effects. During the study, patients will be closely monitored for outcomes including death, rehospitalization for heart failure, worsening heart failure during the hospital stay, and urine output within 48 hours of treatment start. Researchers will use a combined measure called the win ratio to assess these outcomes over 90 days. Participants will undergo clinical evaluations, laboratory tests, and safety assessments throughout the study period to track the drug's impact and monitor for any adverse events.

Researchers are evaluating the effectiveness, safety, and tolerability of subcutaneous lunsekimig compared to a placebo in adults aged 40 to 80 years with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. This Phase 2b/Phase 3, parallel, 3-arm study focuses on participants who have a history of COPD with an eosinophilic profile and have not achieved control with current treatments. Eligible participants will receive either lunsekimig or a matching placebo through subcutaneous injections over a randomized treatment period of approximately 48 weeks. The study involves three periods: an initial screening period lasting up to 4 weeks, followed by the 48-week treatment period, and finally an 8-week follow-up period. The total study duration may last up to 60 weeks. During the study, participants will be regularly assessed for the annualized rate of moderate-to-severe COPD exacerbations from baseline up to 48 weeks. Researchers will monitor safety, tolerability, and treatment effects through various evaluations throughout the treatment and follow-up periods. Participant involvement includes completing assessments and receiving scheduled injections as part of the study protocol.

Researchers are evaluating the long-term effects of iptacopan (LNP023) in people with C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis (IC-MPGN). This open-label extension study follows participants who have completed earlier Phase 2 or Phase 3 studies to gather more data on the drug's safety, effectiveness, and tolerability over an extended period. The study supports regulatory submissions by collecting long-term information about iptacopan's impact on these kidney conditions. Participants receive open-label iptacopan capsules, continuing treatment after completing prior studies CLNP023X2202, CLNP023B12301, or CLNP023B12302. The study includes adults and adolescents with C3G or IC-MPGN and allows continued access to the medication while collecting additional safety and efficacy data. The extension may last up to approximately 168 months or until the drug becomes commercially available or if the benefit-risk balance changes. During the study, researchers monitor participants regularly for kidney function, safety labs, vital signs, ECGs, and adverse events. They measure outcomes such as composite renal endpoints, changes in kidney tissue deposits, and incidence of safety concerns over 6 to 9 months and longer. Participants are expected to continue in the study from a minimum of 60 months up to 84 months or more, with ongoing assessments to support long-term safety and efficacy profiles of iptacopan.