Li Shui Shi

Researchers are conducting a phase 3 study to evaluate the safety and effectiveness of orforglipron for treating hypertension in adults who are overweight or have obesity. The study framework supports two independent trials and aims to better understand how orforglipron works in this specific population with high blood pressure and excess weight. Participants receive orforglipron or a placebo orally once daily. The study includes screening and baseline visits to confirm eligibility based on blood pressure and body mass index. Treatment is randomized and double-blind, meaning neither participants nor researchers know who receives the active medication or placebo during the trial. Throughout the study, researchers monitor blood pressure and other health factors to assess the number of participants assigned to each treatment group. Safety and efficacy are evaluated regularly, with ongoing observation of participants’ response to the medication and any potential side effects.

Researchers are evaluating the safety and effectiveness of orforglipron for treating people who have both hypertension and are either overweight or obese. This study is part of a larger master protocol called GZPL and focuses specifically on these health conditions. The trial is designed as a Phase 3 study to provide important information about this potential treatment. Participants will receive either orforglipron or a placebo, both given orally once daily. The study compares these two groups to understand the impacts of orforglipron on blood pressure and weight-related health issues. The treatment period lasts up to 36 weeks, during which participants are monitored closely. During the study, participants will have their office systolic blood pressure measured to track changes from the start of the trial to week 36. Researchers will also monitor safety and other health measures throughout the trial. The study involves regular visits and assessments to ensure participant well-being and to gather thorough data on the treatment's effects.

This research aims to assess the effectiveness and safety of orforglipron for treating hypertension in adults with obesity or overweight. It is conducted as part of the GZPL master protocol and focuses on participants who have both high blood pressure and elevated body weight. The study is designed as a Phase 3 clinical trial to provide detailed evaluation of this new treatment approach. Participants will receive either orforglipron or a placebo, both given orally once daily. The study compares these two groups to understand the benefits and any side effects of orforglipron when used for managing hypertension in this specific population. The treatment period and detailed dosing schedule are based on the master protocol, which guides participant management and study procedures. During the study, participants will have their systolic blood pressure measured regularly to track changes from the start through week 36. Researchers will monitor safety and treatment effects closely, following all procedures outlined in the master protocol. The overall duration of participant involvement and additional assessments are determined by the master protocol guidelines for this comprehensive evaluation.

Esophageal squamous cell carcinoma (ESCC) is a serious cancer with high rates of diagnosis at advanced stages and poor survival outcomes, especially in China. This research evaluates the combination of induction immunochemotherapy followed by concurrent chemoradiotherapy as a treatment approach for patients with inoperable ESCC. The study also focuses on using circulating tumor DNA (ctDNA) monitoring to predict treatment response and tumor progression, as ctDNA changes may occur before imaging can detect recurrence or metastasis. Participants receive induction immunochemotherapy with toripalimab combined with paclitaxel and cisplatin every three weeks for two cycles. This is followed by concurrent chemoradiotherapy involving weekly paclitaxel and cisplatin for five cycles, along with radiation treatments delivered five days per week. ctDNA testing is performed initially using tissue and blood samples and repeatedly before, during, and after treatment to track tumor DNA changes over time. During the study, patients will undergo regular ctDNA blood tests, clinical assessments, and laboratory tests to monitor treatment effects and safety. Researchers will measure progression-free survival after one year as the primary outcome. The study includes ongoing monitoring of blood markers and physical health to evaluate how well the combined treatment controls the cancer and to explore links between ctDNA results and patient prognosis. Participants are expected to be involved throughout the treatment and follow-up periods as specified.

Researchers are evaluating the safety, tolerability, how the body processes, and the anti-tumor activity of a drug called BGB-B2033 alone and in combination with tislelizumab, with or without bevacizumab. This first-in-human Phase 1 study includes participants who have locally advanced or metastatic hepatocellular carcinoma, alpha-fetoprotein-producing gastric cancer, extragonadal yolk sac tumors or non-dysgerminomas, and glypican-3-positive squamous non-small cell lung cancer. Participants will receive BGB-B2033 through intravenous infusion either alone or combined with tislelizumab, and sometimes with bevacizumab given by intravenous infusion as well. The study evaluates different dosing levels to find the maximum tolerated dose and the recommended dose for Phase 2. Treatment will be monitored over approximately two years in various parts of the study. During the study, participants will have tumor tissue samples collected and undergo assessments including safety monitoring for adverse events, evaluations of tumor response by an independent review committee, and tests to understand drug effects and dosing. The study will measure overall response rates and track safety and tolerability over up to about two years, with ongoing monitoring of health and treatment effects.

Researchers are evaluating the safety and effects of fosmanogepix, a study medicine, for treating candidemia and invasive candidiasis, which are serious fungal infections caused by Candida species. This Phase 3 clinical trial compares fosmanogepix to the standard treatment of caspofungin followed by fluconazole, aiming to show that fosmanogepix is not worse than the standard therapy by a margin of 15%. The study includes adult patients diagnosed with these infections. Participants will receive either fosmanogepix or caspofungin as an intravenous infusion daily at the study clinic. After the initial infusion phase, patients may switch to oral tablets of fosmanogepix or fluconazole capsules, which can be taken at the clinic or at home if discharged. Treatment duration varies by individual, lasting up to six weeks depending on infection clearance and symptom improvement. A follow-up visit will take place six weeks after stopping treatment. During the study, patients will undergo multiple visits to monitor their health and treatment response. Researchers will assess outcomes such as the proportion of patients alive at 30 days and the overall treatment success at the end of study treatment, up to day 42. Safety will be closely monitored throughout the study and during follow-up, ensuring comprehensive evaluation of the treatments over the entire participation period.

Researchers are evaluating the safety and effectiveness of Transarterial Tirapazamine Embolization (TATE) compared to conventional Transarterial Chemoembolization (TACE) in patients with intermediate-stage hepatocellular carcinoma (HCC), a common form of liver cancer. This phase II/III clinical trial aims to determine whether TATE offers benefits over the traditional TACE approach for treating this condition. The study involves two main treatment methods. One group will receive tirapazamine injected directly into the artery feeding the tumor, followed by embolization using lipiodol and gelfoam to block tumor blood vessels and cause tumor hypoxia (TATE). The other group will receive the standard TACE treatment with epirubicin chemotherapy delivered through the arteries to target the tumor. Both treatments are delivered through intra-arterial procedures targeting the liver tumors. Participants will be monitored for up to 36 months to measure progression-free survival, which tracks how long patients live without the cancer worsening. Assessments will include evaluations of liver function, overall health status, and side effects. Safety and treatment responses will be closely followed throughout the study to provide valuable information on the potential advantages of TATE compared to TACE in managing intermediate-stage HCC.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.