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Found 26 Actively Recruiting clinical trials

G

Actively Recruiting

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.

Age: 18Years +All GendersPhase 3
321 locations
P

Actively Recruiting

Researchers are evaluating the safety and effectiveness of LBL-024 combined with other drugs in treating patients with advanced oesophageal squamous cell carcinoma, a type of advanced solid tumor. This open-label, multicenter, Phase II clinical study aims to compare the LBL-024 combination therapy against another drug combination, focusing on how well the treatments control tumor growth and patient response rates. The study begins with a safety run-in period where a small group of patients receive the LBL-024 combination therapy for 21 days to monitor safety and tolerability. Following this, eligible participants will be randomly assigned in a 21 ratio to either the experimental group receiving LBL-024 combined with Paclitaxel and Cisplatin or 5-Fluorouracilcapecitabine plus cisplatin, or the control group receiving Tislelizumab combined with the same chemotherapy drugs. Oral and intravenous drug administrations are included, and the study plans to enroll up to 110 subjects. Participants will have regular visits for treatment administration and monitoring, including laboratory tests to check organ and bone marrow function, tumor assessments using RECIST 1.1 criteria, and evaluation of side effects. Researchers will measure outcomes such as the objective response rate, disease control rate, duration of response, and drug pharmacokinetics. Safety follow-up is conducted up to 28 days after stopping the study drug or before starting new anti-tumor therapy, with the total study period extending until the end of 2028.

Age: 18Years +All GendersPhase 2
7 locations
A

Actively Recruiting

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.

Age: 18Years +All GendersPhase 3
1365 locations
P

Actively Recruiting

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Age: 18Years - 130YearsAll GendersPhase 3
709 locations
P

Actively Recruiting

Researchers are evaluating the addition of Saruparib AZD5305 to standard radiation therapy RT and androgen deprivation therapy ADT for men with high-risk or very high-risk localized or locally advanced prostate cancer who have a BRCA1 or BRCA2 mutation. The study aims to determine if Saruparib improves metastases-free survival compared to placebo when added to these treatments. This phase 3 trial involves approximately 700 adult male participants. Participants are randomly assigned to receive either Saruparib or a matching placebo alongside physicians choice of ADT, with or without abiraterone and prednisoneprednisolone, depending on their cohort. Cohort A includes those receiving RT and continuous ADT, while Cohort B includes participants receiving RT, ADT, and abiraterone. Saruparib and placebo are administered orally. Treatment continues with close monitoring throughout the study. Participants will undergo scans including CT or MRI, bone scans, and PSMA-PET after their planned RT to confirm eligibility and monitor disease status. They will be followed for survival and disease progression for up to approximately 11 years. Researchers will assess metastasis-free survival, overall survival, prostate cancer-specific survival, biochemical recurrence, physical function, and urinary symptoms. Safety and drug levels will also be monitored. An independent committee will review safety and efficacy regularly throughout the trial.

Age: 18Years +MALEPhase 3
342 locations
P

Actively Recruiting

Researchers are evaluating a new medicine called YL201 compared to the standard chemotherapy chosen by doctors in people with locally advanced or metastatic esophageal squamous cell carcinoma who have stopped responding to first-line treatment. The goal is to see if YL201 works better and is safer. The study is a large, randomized phase III trial involving multiple hospitals and also investigates how YL201 is processed in the body, immune reactions it might cause, and whether certain biological markers can predict its effects. Participants will be assigned to one of two groups one group receives YL201 alone, given as an intravenous infusion on the first day of each 3-week cycle. The other group receives a chemotherapy drug chosen by their doctor, which may be paclitaxel, docetaxel, or irinotecan, each given intravenously on specific schedules every 3 weeks. The study treatment continues as planned, with monitoring throughout the treatment period. During the study, participants will undergo regular evaluations including scans and laboratory tests to measure how well the treatments are working and to monitor side effects. The main outcome researchers will track is overall survival for up to about 36 months. They will also assess progression-free survival, response rates, duration of response, and adverse events during this time. The study will last until the end of 2028, with ongoing monitoring and data collection.

Age: 18Years +All GendersPhase 3
81 locations
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Actively Recruiting

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.

Age: 55Years +All GendersPhase 4
40 locations
P

Actively Recruiting

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.

Age: 16Years - 80YearsAll GendersPhase 3
499 locations
P

Actively Recruiting

Researchers are evaluating the efficacy and safety of two inhalers, BDA MDI budesonide and albuterol and AS MDI albuterol sulfate, in reducing severe asthma attacks among symptomatic Chinese adults with asthma. This Phase III, randomized, double-blind, multicenter study involves about 1000 participants who have been diagnosed with asthma and continue to experience symptoms despite maintenance therapy. Participants will be randomly assigned to receive either BDA MDI 160180 mcg two puffs of 8090 mcg or AS MDI 180 mcg two puffs of 90 mcg as needed to relieve asthma symptoms or before exercise. The study includes a screening period lasting 14 to 28 days, followed by a treatment period of at least 24 weeks and up to 52 weeks, and concludes with a safety follow-up about two weeks after the last treatment visit. During the trial, participants will attend regular visits to monitor their asthma control and lung function. Researchers will assess the time to the first severe asthma exacerbation, the rate of exacerbations, steroid use, and responses to asthma control questionnaires. Safety will be carefully followed during and after treatment, with the total participation lasting up to approximately one year.

Age: 18Years +All GendersPhase 3
102 locations
C

Actively Recruiting

Researchers are comparing the effects and safety of two drugs, GQ1005 and Trastuzumab Emtansine T-DM1, in adults with HER2-positive breast cancer that cannot be removed by surgery or has spread to other parts of the body. This phase III trial focuses on patients who have previously been treated with trastuzumab and taxane. The study aims to understand which treatment might better manage this advanced form of breast cancer. Participants will be randomly assigned to receive either GQ1005 or T-DM1. Both drugs are given through intravenous infusions every 21 days. About 228 patients will take part, and the treatments will continue to be monitored over approximately 24 months to assess their impact on cancer progression and safety. During the study, participants will have regular assessments including scans to measure tumor size and blood tests to monitor the drugs in their system. Researchers will track how long patients live without cancer progression, overall survival, response rates, adverse events, and quality of life changes. These evaluations will help understand the benefits and risks of each treatment over time.

Age: 18Years - 75YearsAll GendersPhase 3
70 locations

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