Huaian

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 a new form of hormone therapy called ASP5541 for men with advanced prostate cancer that has spread to other parts of the body. This phase 2 study compares ASP5541 given by injection with the standard abiraterone acetate tablets, both combined with a steroid called prednisone or prednisolone. The study aims to assess how well ASP5541 works and its safety in men who have not previously been treated with androgen receptor pathway inhibitors, including specific evaluation in Japanese men. Participants are divided into three groups based on their cancer type and treatment history. ASP5541 is given as a muscle injection every 12 weeks, while abiraterone acetate is taken as a daily tablet. Men with metastatic castration-resistant prostate cancer take prednisone or prednisolone twice daily, and men with metastatic hormone-sensitive prostate cancer take it once daily. All groups also receive standard care such as androgen deprivation therapy. Some participants will monitor blood pressure at home weekly. During the study, men visit the clinic regularly for health checks, safety monitoring, and scans to observe any changes in their cancer. The frequency and type of visits depend on each participants health and treatment stage. Researchers will measure prostate-specific antigen PSA levels, adverse events, physical exams, ECGs, and performance status to evaluate treatment effects and safety. The study may last up to about 3 years for some outcomes, with longer follow-up for certain measures.

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 efficacy and safety of tulisokibart in participants with moderately to severely active Crohns disease. This program includes two studies Study 1 involves both induction and maintenance treatment phases, while Study 2 focuses only on induction treatment. The main goal is to determine if one or more doses of tulisokibart are more effective than placebo in achieving clinical remission and endoscopic response at various time points up to Week 52. Participants are randomly assigned to receive different dosing regimens of tulisokibart or placebo. These regimens include high or low doses administered intravenously followed by subcutaneous injections, or subcutaneous injections alone. Some participants may continue in an extension phase receiving subcutaneous doses after completing their original treatment arm if they meet specific requirements. The studies use a double-blind design to compare tulisokibarts effects against placebo. During the trial, participants undergo regular assessments to measure clinical remission, endoscopic response, and other health outcomes using tools like the Crohns Disease Activity Index and stool frequency with abdominal pain scores. Safety evaluations include monitoring adverse events and treatment discontinuations. The studies last up to 52 weeks for Study 1 and 12 weeks for Study 2, with multiple visits to assess treatment effects and participant health under medical supervision.

Researchers are studying chronic rhinosinusitis with nasal polyps CRSwNP in Chinese adults to assess nasal polyps score and symptom changes after starting treatment with tezepelumab. This Phase 3b, open-label, single-arm study focuses on participants with an eosinophilic type of CRSwNP, as defined by a specific JESREC score. About 230 participants will be enrolled from multiple sites across China to evaluate this treatments impact on their condition. Eligible participants will receive a fixed dose of tezepelumab 210 mg administered subcutaneously every four weeks for up to 24 weeks, totaling six doses. All doses will be given at the study sites. This study uses a single group design where all participants receive the same treatment, aiming to observe changes over time without a comparison group. Participants will be involved for about 24 weeks during which researchers will assess nasal polyp scores and nasal congestion changes from baseline to the end of treatment. They will also monitor symptom improvements using various patient-reported measures and clinical tests at multiple time points throughout the study. Safety and response to treatment will be carefully tracked to understand tezepelumabs effects on nasal polyps and related symptoms.

Familial hypercholesterolemia FH is an inherited condition that causes high levels of low-density lipoprotein cholesterol LDL-C and increases the risk of early coronary artery disease in both men and women. This research aims to evaluate the effectiveness and feasibility of a child-parent screening program to identify children around 2 years old and their parents who carry FH mutations and are at high risk of inherited heart disease. The study will help establish early diagnosis methods and screening techniques for FH families. The screening process involves multiple steps first, children aged around 2 years will have a fingertip capillary blood test to measure total cholesterol TC. Those with TC above the 95th percentile will be retested, and children with TC above the 99th percentile will undergo whole exome sequencing WES to identify FH mutations. Additionally, parents of children diagnosed with FH through this process will receive TC and mutation testing. The Childrens Hospital of Fudan University will provide further treatment to identified cases. Participants will be involved in the initial blood tests and genetic testing if indicated. Researchers will assess cholesterol levels through fingertip and serum tests, analyze genetic mutations, and determine FH status for both children and their parents. The primary outcome measured is the affected status of familial hypercholesterolemia at enrollment. Secondary outcomes include fasting total cholesterol levels from finger blood tests, FH mutation status, and serum LDL cholesterol levels in children with high TC. The study is observational and will enroll children aged 1 to 3 years.

Researchers are evaluating the efficacy and safety of fospropofol disodium for injection during painless endoscopic diagnosis and treatment, including gastrointestinal endoscopy and colonoscopy, in adults aged 50 to 65 years. This multicenter, randomized, double-blind, controlled clinical study compares fospropofol disodium with propofol to find an appropriate anesthesia method that improves patient comfort, stabilizes anesthesia induction, and reduces adverse events like hypoxemia and cardiovascular complications. Participants are randomly assigned to one of two groups one receives slow intravenous sufentanyl plus fospropofol disodium at 8 mgkg completed within 60 seconds, and the other receives slow intravenous sufentanyl plus propofol at 2 mgkg completed within 60 seconds. Two fixed anesthesiologists administer the drugs. The study focuses on sedation success, anesthesia induction duration, and incidence of hypoxemia, among other safety and effectiveness measures. During the trial, participants undergo painless gastrointestinal procedures while researchers monitor sedation success, total drug doses, intraoperative vital signs, body movements, injection pain, and recovery quality at intervals up to 30 minutes after awakening. The study also tracks hemodynamic stability and adverse reactions to assess the overall safety profile. The total study duration exceeds two years, with careful follow-up to support rapid recovery and reduce hospitalization costs.

Researchers are evaluating lunsekimig, a subcutaneous injection, compared with placebo in adults aged 40 to 80 years with inadequately controlled Chronic Obstructive Pulmonary Disease COPD characterized by an eosinophilic phenotype. This Phase 2bPhase 3 parallel study aims to assess the efficacy, safety, and tolerability of lunsekimig in reducing COPD exacerbations and improving lung function and symptoms. Participants are randomly assigned to one of three groups lunsekimig dose regimen A, lunsekimig dose regimen B, or a matching placebo. They will receive subcutaneous injections during a 48-week treatment period. The study also includes a screening period of up to 4 weeks before treatment and an approximately 8-week follow-up period after treatment, totaling up to 60 weeks of participation. During the study, participants will undergo regular assessments including lung function tests such as post- and pre-bronchodilator Forced Expiratory Volume in 1 second FEV1, questionnaires measuring respiratory health and symptoms, and monitoring of COPD exacerbations. Safety will be evaluated through reported adverse events and laboratory tests. Researchers will also monitor blood levels of lunsekimig and the presence of antidrug antibodies. Participants will be followed closely throughout the study duration to assess treatment impact and safety.

Researchers are evaluating the use of indomethacin, a non-steroidal anti-inflammatory drug NSAID, as an early treatment for acute pancreatitis AP, a condition where the pancreas becomes inflamed due to enzyme activation. The study aims to clarify the effects of NSAIDs on AP treatment, as previous animal studies suggested potential benefits but clinical evidence has been inconsistent. This Phase 4, multi-center, double-blinded, placebo-controlled trial seeks to provide high-quality data on this topic. Participants will be randomly assigned to receive either indomethacin SR 50 mg suppositories every 12 hours from admission day 1 to day 7 alongside standard AP treatments or similar placebo suppositories on the same schedule with standard care. Standard treatment includes adequate intravenous fluids, pain relief, and early enteral nutrition if possible. The study compares these two groups to assess the impact of indomethacin on AP outcomes. During the study, participants will be monitored for organ dysfunction related to AP over one week, which is the primary outcome. Secondary outcomes include rates of pancreatic necrosis, ICU admission, and mortality within one month. Assessments will involve clinical evaluations and imaging. The study runs from admission through at least one month, with close safety monitoring and follow-up to understand treatment effects and patient health outcomes over time.