Zhou Kou 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 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 a facial image-based artificial intelligence AI algorithm designed to screen for coronary artery disease CAD in high-risk community populations, including those with diabetes, hypertension, or aged over 65. The study aims to verify if the AI can accurately identify high-risk and low-risk groups by comparing the actual CAD prevalence, and to compare the AI screening detection rate with natural detection rates in a real-world cohort. Participants are divided into two groups. One group undergoes AI-based facial image screening followed by Coronary Computed Tomography Angiography CCTA to confirm CAD diagnosis. The other group represents a real-world setting without the AI screening and is observed to track natural CAD detection and major adverse cardiovascular events MACE over a six-month follow-up period. During the study, all participants receive monitoring for six months to assess CAD presence and cardiovascular outcomes, including heart attacks and revascularization procedures. Researchers will measure differences in CAD prevalence between AI-identified risk groups, detection rates of CAD, and the incidence of cardiovascular events and deaths. This follow-up period helps evaluate the AI screenings performance compared to usual detection methods.

Primary aldosteronism PA is a common cause of secondary hypertension, and its diagnosis and treatment pose significant challenges. This research investigates adrenal venous sampling AVS, which is considered the best method to distinguish between different types of PA. The study aims to address clinical, technical, and methodological questions about AVS and to understand how AVS-guided management influences long-term health and biochemical results to improve patient care. Participants with PA will undergo adrenal venous sampling through either the antecubital or femoral vein to identify whether aldosterone overproduction is unilateral or bilateral. This observational study evaluates the AVS procedure itself and its clinical outcomes, refining protocols and standardizing practices to optimize treatment decisions and patient prognosis. Throughout the study, researchers will monitor major cardiovascular events one year after AVS. They will also assess procedure success rates, complications, medication changes, blood pressure, heart and kidney function, and clinical outcomes over multiple years. The follow-up includes assessments at 1, 3, 6, 12, 18 months, and up to 10 years, enabling comprehensive evaluation of long-term effects and safety.

Researchers are evaluating the long-term effectiveness and safety of drug-coated balloon DCB strategies, including DCB alone or combined with drug-eluting stents DES, compared to DES-only treatment in patients with chronic total occlusion CTO of coronary arteries after successful reopening. This multicenter randomized controlled trial aims to fill the gap in direct comparative data between DCB and DES treatments for CTO, with the goal of optimizing treatment strategies, reducing stent use, lowering complication risks, and improving patient outcomes. Participants will be randomly assigned to either the DCB group, which involves balloon angioplasty with drug coating and possible provisional DES implantation if needed hybrid strategy, or the DES-only group receiving standard drug-eluting stent placement. Both groups receive standard medical therapy including at least 12 months of dual antiplatelet therapy DAPT. The study includes a 9-month primary endpoint assessment and a 36-month follow-up period to monitor long-term outcomes. During the study, patients will undergo angiographic evaluation for late lumen loss at 9 months, assessed by an independent laboratory using quantitative coronary angiography. Clinical events such as target lesion failure, cardiac death, myocardial infarction, and repeat revascularization will be monitored up to 36 months. Patient-reported outcomes like angina status and quality of life, as well as intravascular imaging and safety parameters, will also be collected. Overall participation spans over three years with regular follow-up visits to assess treatment effects and safety.

Acute ischemic stroke is a leading cause of death worldwide, and intravenous thrombolysis with recombinant tissue plasminogen activator rt-PA within 4.5 hours of symptom onset is the most effective treatment currently available. However, some patients experience stroke progression and early reocclusion after thrombolysis, which can worsen neurological outcomes. This trial evaluates whether early antiplatelet therapy with oral aspirin, given soon after thrombolysis, can improve recovery without increasing bleeding risks. The study randomly assigns patients to receive either early oral aspirin within 3 hours of starting intravenous thrombolysis or a placebo, alongside the best medical care based on current guidelines. Aspirin is administered as a 300 mg dose, either chewed or given via nasogastric tube if swallowing is difficult. The trial includes a control group receiving placebo under similar conditions to compare outcomes. This is a Phase 3, multicenter, quadruple-blind, randomized clinical trial. During the study, participants will be closely monitored for neurological status and functional recovery using the modified Rankin scale at 30 and 90 days after stroke, as well as other assessments like NIH Stroke Scale scores within the first week. Researchers will track early neurological changes and safety outcomes such as intracranial hemorrhage. Follow-up will include evaluations at multiple time points up to 90 days post-stroke to determine the effects of early antiplatelet treatment on stroke recovery.

Researchers are investigating the safety and effectiveness of combining an interleukin-6 receptor inhibitor called tocilizumab with endovascular therapy for patients who have acute posterior circulation large-vessel occlusion stroke. This phase III clinical trial uses a randomized, double-blind, placebo-controlled design to assess whether adding tocilizumab can improve outcomes compared to endovascular treatment alone. The study is led by Capital Medical University and focuses on patients with this specific type of ischemic stroke. Participants will be randomly assigned to receive either endovascular treatment combined with a single intravenous infusion of 240 mg tocilizumab or endovascular treatment combined with a placebo infusion. The infusion is diluted to 100 mL and administered within 30 minutes after randomization, lasting more than one hour. The study will compare these two groups to evaluate the effects of the added tocilizumab treatment. During the study, researchers will monitor patients for 90 days, assessing their recovery using the modified Rankin Scale mRS to measure disability and function. Other assessments include neurological improvement at 24 hours, NIH Stroke Scale scores at 7 days or discharge, quality of life using EQ-5D-5L, and the Barthel Index for daily living activities. Safety and efficacy will be closely followed through clinical evaluations and standard laboratory tests throughout the trial period.

Researchers are evaluating Linperlisib, a PI3K delta inhibitor, in patients with relapsed or refractory large granular T lymphocytic leukemia T-LGLL. This phase 2, multicenter, single-arm study aims to assess the effectiveness and safety of Linperlisib in treating this rare blood cancer. The study is sponsored by the Institute of Hematology & Blood Diseases Hospital in China. Participants will receive Linperlisib orally at a dose of 80 mg daily in 28-day cycles. Treatment will continue until the disease progresses or intolerable side effects occur. This single-arm study focuses on monitoring patients over the course of their therapy without using a comparison group. During the study, patients will be regularly evaluated for hematologic remission between 8 to 12 weeks after starting treatment. Researchers will also monitor for any adverse events or side effects. Participant involvement includes clinical assessments, laboratory tests, and safety monitoring throughout the treatment period until disease progression or unacceptable toxicity. The study is expected to complete by January 2026.

Researchers are evaluating the efficacy and safety of oral minocycline in patients who have experienced an acute spontaneous intracerebral hemorrhage within 48 hours of onset. This prospective, multicenter, randomized, double-blind, placebo-controlled Phase III trial aims to improve patient outcomes and explore the effects of minocycline on venous neuroinflammation in this condition. Participants will be randomly assigned to receive either minocycline or a matching placebo for 5 days alongside standard medical care. The minocycline group will take an initial dose of 200 mg immediately after randomization, followed by 100 mg every 12 hours for a total of 10 doses. Those with swallowing difficulties may receive the medication through a nasal feeding tube. The trial includes screening, treatment, and follow-up phases with visits scheduled at screening, 72 hours, 7 days, 90 days, and 180 days after randomization. During the study, participants will undergo assessments including neurological evaluations and imaging at specified time points. Researchers will measure outcomes such as the modified Rankin Scale score at 90 days, changes in neurological scores, inflammation markers, and stroke recurrence. Safety and efficacy will be monitored through these evaluations, with total participation lasting up to 180 days post-randomization.

This research aims to evaluate the safety and effectiveness of TQA2225AP025, a recombinant human FGF21-Fc fusion protein, in adults with Non-Alcoholic Steatohepatitis NASH. It is a randomized, double-blind, placebo-controlled Phase II study designed to assess how well two different doses of this treatment work in managing NASH, a liver condition characterized by fat buildup and inflammation. Participants will receive either 25mg or 50mg of TQA2225AP025 or a matching placebo, given by weekly subcutaneous injections for 48 weeks. The study includes two experimental groups receiving the different doses, and all treatments are administered under blinded conditions to assess the treatment effects accurately. During the study, participants will undergo liver biopsies at the start and after 48 weeks to measure changes in liver condition using the NASH CRN scoring system. Safety will be closely monitored by tracking any adverse events throughout the treatment period. The study is expected to provide detailed information on both the treatment impact on liver health and its safety profile over nearly a year of participation.