Xuan Cheng Shi

Researchers are evaluating the efficacy and safety of elecoglipron, an oral tablet taken once daily, for weight management in adults with obesity or overweight. This Phase III global, randomized, double-blind, placebo-controlled trial includes two independent pivotal studies one in adults without type 2 diabetes T2DM and the other in adults with T2DM, all having at least one weight-related health condition. The goal is to understand how elecoglipron compares to placebo when combined with diet and exercise. Participants will be randomly assigned to receive either one of two doses of elecoglipron or a matching placebo daily. Study 1 involves about 3000 adults living with obesity or overweight without T2DM, while Study 2 involves about 1500 adults with obesity or overweight and T2DM. Both studies last 72 weeks, during which changes in body weight and other health measures will be monitored. During the trial, participants will undergo regular health assessments including measurements of body weight, waist circumference, blood sugar control, blood pressure, and other related health indicators. Researchers will track percent change in body weight from baseline at 72 weeks as the primary outcome. Participants will be monitored closely throughout the study to assess safety and effectiveness of the treatment in managing weight and associated health conditions.

Researchers are evaluating the effectiveness, safety, and tolerability of elecoglipron alone or combined with dapagliflozin compared with a placebo in adults with type 2 diabetes mellitus T2DM who are not adequately controlled by lifestyle management alone or who are on other background glucose-lowering medications. This Phase III study aims to understand how these treatments impact blood sugar control and related health factors. Participants will be randomly assigned to one of four groups elecoglipron at dose level 1 with dapagliflozin-matched placebo, elecoglipron at dose level 2 with dapagliflozin-matched placebo, a combination of elecoglipron at one of the studied doses with dapagliflozin, or matching placebos for both drugs. All treatments are taken orally once daily. The study uses a quadruple-blind design to compare these options over a treatment period lasting up to 40 weeks. During the study, participants will have their blood sugar levels measured by changes in Hemoglobin A1c HbA1c from baseline to week 40. Other assessments include body weight, blood pressure, and the time to start any additional rescue medication. Participants will attend regular visits for monitoring and safety evaluations throughout the study duration, which extends until the primary completion date in July 2028.

This trial is for adults who have had an acute ischemic stroke caused by a blood clot blocking a brain vessel. It focuses on people whose stroke occurred or was discovered more than 4.5 hours ago, including those who woke up with stroke symptoms. The study aims to find out if the medicine tenecteplase helps recovery when given after this 4.5-hour window, compared to standard medical care. Tenecteplase is already used within 4.5 hours after stroke onset, but this study tests its effect when given later. Participants are randomly assigned to one of two groups one receives a single injection of tenecteplase into a vein, and the other receives the usual standard treatment. Both groups have an equal chance of receiving either treatment. The study lasts about three months, starting with approximately one week of hospital stay. During the study, participants have seven clinical examinations or visits, with the final two visits conducted remotely from home to allow for easier participation. Throughout the study, doctors regularly assess participants recovery using a scale that measures disability and dependence in daily activities. They also monitor overall health and record any side effects. The main outcome measured is the level of recovery 90 days after treatment, comparing the two groups. This includes neurological improvement, bleeding events, and survival over the study period.

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 whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.

Researchers are establishing a standardized clinical database for patients with liver cancer, including hepatocellular carcinoma and related types, to support high-quality real-world clinical studies. This observational study is led by the Department of Hepatobiliary Surgery at the First Affiliated Hospital of the University of Science and Technology of China USTC in collaboration with multiple centers nationwide. The purpose is to collect detailed clinical information to better understand liver cancer outcomes over time. Participants will receive routine clinical treatments for liver cancer, such as surgical resection, ablation, transarterial chemoembolization TACE, hepatic arterial infusion chemotherapy HAIC, and various anti-tumor drugs including immunologic, targeted, and chemotherapy agents. The study observes and records these standard treatments without assigning interventions. The research will track these patients in a cohort database to monitor their treatment and progression. During the study, participants will be followed for up to 10 years to assess overall survival, recurrence-free survival, and survival time after cancer recurrence. Researchers will collect blood and surgical tissue samples and perform regular follow-up visits to gather clinical data and pathology results. This long-term monitoring aims to provide comprehensive insights into liver cancer progression and treatment outcomes.

Researchers are evaluating the drug TNTL to treat adults with non-proliferative diabetic retinopathy, a condition related to diabetes that affects the eyes. This Phase III clinical study aims to find out if TNTL can improve vision and reduce the severity of retinopathy compared to a placebo. It also assesses the safety of TNTL for participants with this eye condition and specific traditional Chinese medicine syndromes. Participants are randomly assigned to receive either TNTL or a placebo, taking 4 tablets orally three times a day after meals for 24 weeks. The study includes a double-blind design where neither participants nor researchers know who receives the drug or placebo. Visits to the clinic occur every 4 weeks for checkups and testing throughout the 6-month treatment. During the study, participants will have their vision measured using the best corrected visual acuity BCVA test at multiple time points, along with eye exams including retina imaging and optical coherence tomography. Blood tests will monitor blood sugar control and safety indicators. Participants will keep a diary to track symptoms and changes. Safety and effectiveness are closely observed throughout the treatment period.

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 effectiveness and safety of two low-dose atropine sulfate eye drops 0.01% and 0.02% in slowing the progression of myopia in children and adolescents aged 6 to 12 years. This randomized, double-blind, placebo-controlled Phase III trial aims to compare these treatments against a placebo over 96 weeks, with an exploratory period extending to 144 weeks to assess long-term effects and potential rebound after stopping treatment. Participants receive either 0.01% atropine, 0.02% atropine, or placebo eye drops, applying one drop in each eye every night before sleep. Each application is followed by gently pressing the tear duct area on both sides for about one minute. The study includes a 96-week treatment period with evaluations and an optional extended follow-up to monitor sustained treatment effects and safety. Throughout the study, children will attend regular visits for eye exams measuring changes in vision and eye length. Researchers will assess the degree of myopia progression and safety at 12 and 24 months, including tests of refraction and ocular morphology. Careful monitoring ensures adherence to treatment and tracks any side effects, with the primary outcome being the change in spherical refraction after 96 weeks.