Liao Cheng Shi

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 the safety and tolerability of DB-1303BNT323 in adults with advanced or metastatic solid tumors that express HER2. This Phase 12a trial focuses on patients with tumors that are advanced, unresectable, recurrent, or metastatic and have limited or no standard treatment options. The study aims to identify the best dose and explore early signs of effectiveness in a variety of HER2-expressing cancers. The trial has two parts an initial dose-escalation phase using an accelerated titration followed by a classic 33 design to find the maximum tolerated dose MTD or recommended Phase 2 dose RP2D, and a dose-expansion phase to further assess safety, tolerability, and potential effects at the established dose. Participants receive DB-1303BNT323 by intravenous infusion once every three weeks Q3W at various dose levels. Some groups are randomized to receive different dose levels or combinations with other drugs like Pertuzumab, Ritonavir, or Itraconazole to study drug interactions and responses. During the study, participants will have regular assessments including monitoring for dose-limiting toxicities, adverse events, and serious adverse events using standard criteria up to about one year after treatment. Researchers will also evaluate tumor responses using RECIST 1.1 criteria and collect pharmacokinetic and pharmacodynamic data. Other evaluations include heart function tests, organ function, and overall health status. The study duration varies per participant, with follow-up visits extending up to one year post-treatment to monitor safety and treatment effects.

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.

Researchers are evaluating the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults who have type 2 diabetes mellitus T2DM with impaired kidney function. Participants are also on dapagliflozin 10 mg as part of their guideline-directed medical therapy for chronic kidney disease CKD, along with other glucose-lowering medications. This Phase III study aims to understand how elecoglipron performs in this specific group of patients. Participants will be randomly assigned to one of three groups elecoglipron at dose level 1, elecoglipron at dose level 2, or placebo. All treatments are given orally once daily alongside background dapagliflozin 10 mg. The study uses a parallel design and includes a 40-week treatment period during which participants take their assigned medication. During the study, participants will have their blood sugar control measured through Hemoglobin A1c HbA1c levels from baseline to Week 40, which is the primary outcome. Additional assessments include body weight changes, blood pressure, fasting plasma glucose, and time to needing additional diabetes medication. Safety and tolerability will be monitored throughout the study, which lasts up to 40 weeks for each participant.

Bladder cancer is a common and serious tumor that originates from the bladders lining, with the majority being non-muscle invasive bladder cancer NMIBC. NMIBC has a high recurrence rate even after initial treatment, making postoperative bladder perfusion chemotherapy important to prevent tumor return. This research evaluates the use of patient-derived bladder cancer organoids to test drug sensitivities and guide individualized chemotherapy, aiming to improve treatment effectiveness and reduce recurrence for bladder cancer patients. The study involves preparing bladder cancer organoids from tumor tissue collected during surgery. Researchers perform drug sensitivity testing on these organoids with various chemotherapeutic agents, including gemcitabine, pirenzolubicin, epirubicin, mitomycin, and doxorubicin. Based on organoid sensitivity results, patients receive bladder perfusion chemotherapy with either sensitive or non-sensitive drugs, or receive BCG vaccine infusions. Treatment schedules include induction perfusion weekly for 4 weeks and maintenance perfusion monthly for 11 months, or BCG infusions following an induction and maintenance regimen over one year. Participants undergo regular clinical assessments including cystoscopy, urine cytology, and imaging as needed to monitor tumor recurrence and progression over up to three years. Researchers analyze one-year and three-year tumor recurrence-free and progression-free survival rates among groups. The study monitors patient compliance, adverse events, and clinical outcomes to assess the value of organoid drug sensitivity testing in guiding personalized bladder cancer perfusion chemotherapy.

Researchers are evaluating the efficacy and safety of ABP1011T tablets in participants with advanced solid tumors, including small cell lung cancer, esophageal cancer, cervical cancer, bladder cancer, and renal cell carcinoma. This open-label, multi-cohort Phase IIb study builds on prior safety and efficacy data from an earlier clinical trial. Priority enrollment is given to patients with small cell lung cancer who have failed at least two prior systemic therapies. Participants receive ABP1011T tablets orally once daily on an empty stomach with water, avoiding food for at least one hour before and after dosing. Treatment follows a continuous 21-day cycle, and the study includes multiple cohorts Cohort A focuses on small cell lung cancer patients, while Cohort B includes other advanced solid tumors. The study treatment is administered continuously throughout the trial. During the study, participants undergo regular assessments to monitor treatment effects and safety, including evaluations of tumor response using the objective response rate ORR over approximately two years. Secondary outcomes include duration of relief, progression-free survival, disease control rate, sustained response rate, overall survival, and treatment-related adverse events. Participants are monitored closely for up to two years to assess the impact of the study drug.

Researchers are evaluating the efficacy and safety of GB491 combined with Letrozole compared to placebo combined with Letrozole in treating patients with hormone receptor-positive HR and human epidermal growth factor receptor 2-negative HER2- locally advanced or metastatic breast cancer. This study focuses on patients who have not previously received systemic antitumor therapy for this condition and aims to provide new treatment insights. Participants are randomly assigned to one of two groups one receives GB491 at 150 mg orally twice daily along with Letrozole 2.5 mg orally once daily, while the other receives a placebo twice daily with the same Letrozole dose. Treatment cycles last 28 days, and the study is designed as a randomized, double-blind, placebo-controlled phase III trial. During the study, participants will be closely monitored for progression-free survival assessed by investigators using RECIST v1.1 criteria over approximately 60 months. Additional measures include overall survival, response rates, duration of response, disease control rates, clinical benefit rates, and the frequency and severity of adverse events. Regular assessments ensure safety and treatment adherence throughout the study period.

Researchers are evaluating whether Extract of Ginkgo Biloba Leaves Tablets can improve memory and thinking skills in people aged 55 and older who have had an ischemic stroke caused by a blocked blood vessel in the brain. This study also looks at the safety of taking these tablets alongside usual post-stroke treatments. Participants must have had a stroke confirmed by MRI within 7 to 14 days before joining the study and have mild cognitive impairment after their stroke. Participants will be randomly assigned to one of two groups one group will take 240 mg of Extract of Ginkgo Biloba Leaves Tablets daily for 12 months in addition to their usual stroke care, while the other group will receive only their usual care without the tablets. The study will take place at hospitals across China and will last for 52 weeks for each participant. Throughout the study, participants will visit the clinic at 4, 26, and 52 weeks after starting treatment for checkups and tests, including brain scans, cognitive assessments such as the Montreal Cognitive Assessment and other neuropsychological tests, and evaluations of neurological function. Follow-up phone calls will occur at 12 and 38 weeks to monitor health and any new stroke events. Researchers will measure changes in thinking, memory, cognitive speed, verbal skills, and neurological status to understand the tablets effects and safety over time.

Researchers are studying the safety and effectiveness of a single dose of PN20 in treating thrombocytopenia in adult patients with chronic liver disease who are undergoing elective procedures. This phase IbII trial aims to find out how well PN20 works and if it is safe for these patients, who have a low platelet count and specific liver disease conditions. The study is open-label in phase Ib and randomized, double-blind, placebo-controlled in phase II. The study has two stages phase Ib involves giving single doses of PN20 at increasing levels to small groups of patients to evaluate safety and dosing. Phase II randomly assigns patients to receive either one or two selected PN20 dose levels or a placebo via a single subcutaneous injection before their elective procedure. The doses used in phase II depend on the results from phase Ib. Participants will receive one injection and attend clinic visits for assessment. Researchers will monitor the proportion of patients who respond within 8 days around the surgery, as well as adverse events, drug levels in the body, and immune responses up to 28 days after dosing. The study lasts about one month per participant, focusing on safety, tolerability, and treatment effects.

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.