Chiyoda City

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the efficacy and safety of brenipatide combined with standard of care compared to placebo plus standard of care in delaying the worsening of symptoms in adults with bipolar disorder. This Phase 2, randomized, double-blind study aims to understand if brenipatide can help delay relapse in bipolar disorder patients. The study is sponsored by Eli Lilly and Company and focuses on adults aged 18 to 75 years diagnosed with bipolar disorder I or II. Participants will be randomly assigned to receive one of two doses of brenipatide or a placebo, each administered by subcutaneous injection alongside their standard of care medication. The trial is divided into three periods a screening period lasting about one month, a treatment period lasting at least six months, and a follow-up period lasting approximately two months. The total duration of participation may vary and can be shortened if symptoms worsen or if the participant withdraws. During the study, participants will self-inject the study medication, maintain study diaries, and complete questionnaires assessing their condition. Researchers will monitor time to relapse, changes in functional impairment, mood symptoms using specific rating scales, quality of life, patient global impressions, body weight, and pharmacokinetics. Safety will be closely observed, including the presence of treatment-emergent anti-drug antibodies. Participants are expected to attend regular visits throughout the treatment and follow-up periods.

Researchers are evaluating the safety and effectiveness of brenipatide alongside standard care compared to a placebo plus standard care in adult participants with major depressive disorder. This study aims to see if brenipatide can delay the return of major depressive symptoms. It is a Phase 3, randomized, double-blind trial sponsored by Eli Lilly and Company. Participants receive brenipatide or placebo through subcutaneous injections combined with their regular treatment. The study includes three periods a screening period lasting about 1 month, a treatment period of at least 12 months, and a follow-up period of about 2 months. The study duration may be shortened if depressive symptoms worsen or if participants withdraw. During the trial, participants will attend regular visits where various assessments will be conducted, including depression rating scales, functional impairment scores, and quality of life questionnaires. Researchers will monitor body weight changes, anxiety levels, and blood samples to measure drug levels and immune responses. The primary outcome is the time until relapse of major depressive disorder symptoms. Safety and adherence to self-injection and study procedures will be closely followed throughout participation.

Researchers are conducting a Phase 3 randomized study to evaluate the safety, effectiveness, tolerability, and how the body processes pharmacokinetics the oral drug JNT-517 in adults aged 18 years or older who have phenylketonuria PKU. The study aims to compare JNT-517 with a placebo to understand its impact on plasma phenylalanine levels and other health outcomes related to PKU. Participants will be randomly assigned to receive either JNT-517 or a placebo for the first six weeks, with about a 67% chance of receiving JNT-517. After this initial period, all participants continuing in the study will receive one of two doses of JNT-517 75 mg or 150 mg twice daily for an additional 46 weeks. The study includes a screening period of up to 35 days to ensure dietary stability and proper amino acid levels before treatment begins. During the study, participants will take the study medication twice daily for up to 365 days. They will attend clinic visits or receive visits from a mobile health nurse for checkups and tests. Participants will also collect urine samples at home on specific days and keep a food diary for three days before each visit. Researchers will measure changes in plasma phenylalanine levels, ADHD symptoms, dietary intake, and monitor for any treatment-emergent adverse events throughout the study.

This research aims to evaluate how well and safely orforglipron works in adult female participants with stress urinary incontinence SUI who also have obesity or are overweight. SUI is a condition where urine leaks during activities such as coughing or exercising. The study is a Phase 3 clinical trial conducted under a master protocol supporting two independent studies, focusing on this specific population. Participants will be randomly assigned to receive either orforglipron or a placebo, both given orally once daily. The study uses a double-blind design with parallel groups to compare the effects of orforglipron against placebo. The treatment period lasts approximately 52 weeks, followed by safety follow-up, making total participation about 58 weeks from screening to study completion. During the study, participants will undergo assessments including measuring changes in the frequency of incontinence episodes, body weight, quality of life related to urinary incontinence, use of continence pads, and cholesterol levels. Researchers will monitor waist circumference and patient impressions of their condition as well. Safety follow-up continues after treatment to ensure participant well-being throughout the study duration.

Researchers are evaluating the effectiveness and safety of Corabotase IPN10200 in adults with moderate to severe glabellar lines, which are wrinkle-like lines between the eyebrows that may affect appearance and confidence. This Phase III study compares a single dose of Corabotase to a placebo in a double-blind phase, followed by an open-label phase to assess repeat doses over time. Participants will receive injections of Corabotase or placebo into selected facial muscles. The study includes a screening period of up to 20 days, a treatment period with up to four treatment cycles where participants may receive Corabotase or placebo in the double-blind phase and Corabotase in the open-label phase, and a follow-up period lasting 24 weeks after the last injection. Multiple visits occur during the first month of treatment, followed by monthly visits. During the study, participants will have health assessments including blood tests, physical exams, ECGs, questionnaires, and diaries. Researchers will measure treatment response at week 4 and monitor safety and satisfaction through week 104. Total participation lasts up to 107 weeks, and participants may withdraw at any time.

Researchers are evaluating the effectiveness and safety of a combination of follitropin alfa and lutropin alfa in Japanese women with luteinizing hormone LH and follicle stimulating hormone FSH deficiency who are undergoing assisted reproductive technology ART. This Phase 3 study focuses on women who have had at most one previous ART stimulation without pregnancy and aims to compare this combination product with human menopausal gonadotropin hMG. Participants will receive either a fixed combination of recombinant follitropin alfa and lutropin alfa in a 21 ratio or hMG during ovarian stimulation. The follitropin alfalutropin alfa combination is administered subcutaneously once daily starting with 150 IU of follitropin alfa and 75 IU of lutropin alfa for up to 18 days. Additional medications such as cetrorelix acetate, corio gonadotropin alfa, and progesterone gel are used during ovarian stimulation, final follicular maturation, and luteal phase support. During the study, participants will be monitored through vaginal ultrasound scans, semen analysis, and cytologic tests. Researchers will measure the total number of oocytes retrieved, hormone levels, number of follicles, fertilization rates, blastocyst freezing, and pregnancy outcomes. Safety will be assessed by tracking adverse events, ovarian hyperstimulation syndrome occurrences, laboratory changes, and local reactions over approximately 5.5 months for nonpregnant participants and up to 13 months for those with confirmed pregnancy.

Researchers are evaluating the efficacy and safety of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease COPD who are receiving inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on adults aged 40 to 80 years who have experienced multiple COPD exacerbations in the year prior to enrollment. The trial aims to assess tezepelumabs impact compared to placebo on COPD exacerbations and lung function. Participants will receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. Treatment duration ranges from a minimum of 52 weeks to a maximum of 76 weeks. Following the treatment period, participants will undergo a 12-week off-treatment safety follow-up to monitor any lasting effects. Throughout the study, participants will be regularly assessed for COPD exacerbations, lung function changes measured by forced expiratory volume FEV1, and quality of life using questionnaires such as the St. Georges Respiratory Questionnaire and COPD Assessment Test. Blood samples will be collected to measure drug levels and immune responses. Safety and efficacy will be closely monitored, with total participation lasting up to approximately 88 weeks including follow-up.

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 evaluating two different approaches to antithrombotic therapy after Left Atrial Appendage Closure LAAC in people with non-valvular atrial fibrillation who have a high risk of bleeding. The study compares Non-Antithrombotic Therapy NAPT followed by oral anticoagulants OAC monotherapy for 45 days against Single Antiplatelet Therapy SAPT with aspirin. This Phase 4 trial aims to determine if the NAPT approach is not worse than SAPT over an observation period of up to 4 years, focusing on a combination of serious events including death, heart attack, stroke, embolism, and bleeding complications. Participants are randomly assigned to one of two groups the SAPT arm or the NAPT arm, with equal chance of assignment. Both groups start with oral anticoagulants for 45 days after LAAC. After this period, the SAPT group continues with low-dose aspirin, while the NAPT group does not receive further antithrombotic medication for the remainder of the study. The study includes visits at 45 days, 1 year, and 2 years after enrollment, along with telephone follow-ups up to 4 years. During their participation, subjects will undergo clinical evaluations to monitor safety and effectiveness, including imaging tests to check for device-related thrombus at specific intervals. Researchers will track major health events such as mortality, heart attacks, strokes, embolism, and bleeding incidents throughout the study. The study includes regular hospital visits, phone assessments, and ongoing observation, lasting up to 4 years per participant to thoroughly assess long-term outcomes.