Nan Yang Shi

Researchers are evaluating the effectiveness and safety of B001 injection in patients who have neuromyelitis optica spectrum disorder NMOSD and test positive for aquaporin-4 antibodies. This condition involves recurrent attacks affecting the nervous system. The study is a multicenter, randomized, double-blind, placebo-controlled trial conducted in phases II and III to understand how well B001 works and how safe it is for these patients. Participants will receive intravenous doses of either B001 or a placebo on Day 1 and Day 15 during the randomized controlled period. The study includes two groups one receiving B001 injections and the other receiving placebo injections matching B001s schedule. The trial will extend over several years, monitoring patients closely for disease relapse and treatment side effects. During the study, participants will be regularly assessed for the time to their first NMOSD attack, changes in disability status, vision acuity, and opticospinal function. Researchers will also observe the annual relapse rate and document any adverse events. The trial includes safety monitoring for about three years to ensure comprehensive data collection on treatment impact and participant health.

Researchers are evaluating the safety and early effectiveness of an injectable drug called IMC-001 in improving the stability of atherosclerotic plaques in patients diagnosed with acute coronary syndrome ACS, which includes conditions like acute myocardial infarction or unstable angina. This early phase 1, randomized, double-blind, placebo-controlled study is being conducted at two centers and aims to better understand how IMC-001 affects plaque stability in these patients. The study involves two dose groups with nine subjects each, where six receive IMC-001 plus optimal medical therapy and three receive a placebo plus optimal medical therapy. Participants will receive injections of either IMC-001 or placebo alongside standard treatments for coronary artery disease. The trial includes a dose escalation design to assess safety and preliminary efficacy. Participants will be monitored for changes in coronary artery low-attenuation plaque volume using coronary computed tomography angiography CCTA at baseline and again six months after treatment. The study will track safety, plaque volume changes, and other clinical assessments during the treatment and follow-up periods. The total participation duration includes the treatment phase and a six-month evaluation after dosing to assess the primary outcome measure.

Researchers are evaluating the efficacy and safety of TQB6411 for Injection in adults with advanced lung cancer. This phase IbII clinical trial focuses on patients aged 18 to 75 years who have lung cancer confirmed by histology or cytology and meet specific health criteria. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and aims to determine the recommended phase II dosage and measure response rates over time. Participants will receive TQB6411 for Injection as the treatment, administered in cycles every 21 or 28 days. The study includes monitoring for response rates, disease control, duration of relief, progression-free survival, overall survival, adverse events, and the presence of anti-drug antibodies. Blood samples will be collected at specified cycles and timepoints before and after dosing to assess drug levels and immune responses. During the study, participants will be evaluated for tumor response using recognized criteria and undergo laboratory tests to monitor safety and drug effects. The study duration includes follow-ups up to three years for overall survival assessment. Participants will be regularly monitored for side effects and treatment efficacy to ensure comprehensive data collection throughout the trial period.

Researchers are evaluating the safety, tolerability, and effectiveness of a drug called RC278 for treating locally advanced unresectable or metastatic malignant solid tumors. The study aims to find the highest safe dose, the recommended dose for further testing, and to assess how well RC278 works at that dose. This trial is a combined Phase III clinical study sponsored by RemeGen Co., Ltd., focusing on patients with solid tumors who meet specific health criteria. The study includes several stages starting with five groups receiving increasing doses of RC278 to identify the maximum tolerated dose or maximum administered dose. Following this dose-escalation, selected doses will be further tested in a randomized manner to determine the recommended Phase II dose. In the expansion phase, this dose will be studied in different types of cancers to further evaluate safety and effectiveness. RC278 is given intravenously every three weeks, and treatment continues until unacceptable side effects occur, the disease progresses, or the participant withdraws. Participants will be monitored for up to 24 months to track dose-limiting toxicities, adverse events, and tumor response using standard criteria. Assessments include imaging to measure tumor size, safety evaluations, and pharmacokinetic testing. The study collects data on how well participants tolerate the drug and how their tumors respond. Follow-up continues throughout the study to ensure participant safety and to gather comprehensive information on the drugs effects.

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 effectiveness of early treatment with BXOS110 injection in reducing disability for patients who have had an acute ischaemic stroke. This phase 3 clinical trial compares BXOS110 to a placebo to better understand its safety and impact when given within three hours of stroke onset. The study includes adults aged 18 to 85 diagnosed with acute ischaemic stroke, with specific neurological and functional criteria for participation. Participants are randomly assigned to one of two groups one receiving a single intravenous infusion of BXOS110 at a dose of 3.0 mgkg up to 300 mg, and the other receiving a placebo infusion of the same volume and dose schedule. The study is double-blind and placebo-controlled, meaning neither participants nor researchers know which treatment is given. The trial consists of a screening and baseline phase, a treatment phase with immediate administration of the study drug, followed by a follow-up period with evaluations on days 2, 3, 10 or at discharge, day 30, and day 90 after treatment. Throughout the study, participants undergo assessments to measure disability and neurological function, including the modified Rankin Scale mRS, NIH Stroke Scale NIHSS, Barthel Index BI, and EQ-5D quality of life questionnaire. The main outcome measured is the proportion of patients achieving an mRS score of 0 to 2 on day 90, indicating good recovery. Safety and efficacy are monitored closely during follow-up visits and at discharge. The total study duration includes screening, treatment, and a 90-day follow-up period to assess outcomes and safety.

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 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.

Researchers are evaluating the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults with Type 2 Diabetes Mellitus T2DM who are already being treated with insulin and other glucose-lowering medications. This Phase III study focuses on adults with T2DM who have had the condition for at least 90 days and meet certain health criteria. 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 taken orally once daily. The study treatment period lasts up to 40 weeks, during which participants continue their background insulin and glucose-lowering medications. During the study, participants will have regular assessments to monitor changes in blood sugar control, including Hemoglobin A1c HbA1c, body weight, blood pressure, and insulin dose. Researchers will also track safety, side effects, and tolerability. The main outcome is the change in HbA1c from baseline to Week 40. Overall, participation involves visits for monitoring and evaluations over approximately 40 weeks.