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Found 9 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the efficacy and safety of enicepatide, a dual GLP-1GIP receptor agonist, at multiple doses compared with placebo for weight management in adults with obesity or overweight and type 2 diabetes mellitus T2DM. This Phase III study aims to better understand how enicepatide affects body weight and other health measures in this population. Participants will be randomly assigned to receive either placebo or one of three dosing regimens of enicepatide, administered once weekly using an integrated drug-device combination product. The study lasts for 72 weeks, during which participants will self-administer the study drug or receive injections from a trained individual if needed. Throughout the study, participants will undergo various assessments including body weight, hemoglobin A1c, waist circumference, fasting glucose and insulin, cholesterol levels, blood pressure, and quality of life questionnaires. Safety will be monitored through adverse event reporting and specific rating scales. This comprehensive evaluation will help determine the effects of enicepatide on weight and diabetes management over the study period.

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

Researchers are evaluating the efficacy, safety, and tolerability of combining elecoglipron and dapagliflozin compared to each drug alone in adults with type 2 diabetes mellitus T2DM who have not achieved adequate control through lifestyle changes or other glucose-lowering medications. This Phase III study aims to better understand how these treatments work together in managing blood sugar levels in this population. Participants are randomly assigned to one of five groups two groups receive elecoglipron at different dose levels combined with dapagliflozin two groups receive elecoglipron at different dose levels combined with a placebo matching dapagliflozin and one group receives dapagliflozin alone with a placebo matching elecoglipron. All medications are taken orally once daily. The treatment period lasts 40 weeks, during which the effects of the drugs on blood sugar and other health measures will be monitored. Throughout the study, participants will have regular assessments of their blood sugar control, body weight, and blood pressure. Researchers will measure changes in Hemoglobin A1c HbA1c, fasting plasma glucose, and self-monitored blood glucose levels. Other outcomes include weight loss and the need for rescue medication. Safety and tolerability will be closely monitored. Participation in the trial lasts for 40 weeks, during which participants will attend scheduled visits for evaluation and medication monitoring.

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

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Age: 40Years - 80YearsAll GendersPhase 3
921 locations
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Actively Recruiting

Healthy Volunteer

Dengue fever is caused by infection with the dengue virus. This trial studies how safe and effective the Dengue Tetravalent Vaccine TDV is in activating the immune system of young children aged 6 to 21 months. The study aims to better understand the vaccines safety and immune response in infants and toddlers. Children will receive two doses of either TDV or a placebo injection, given three months apart. Participants are divided into two age groups 6 to less than 12 months and 12 to less than 21 months. Each group receives either the vaccine or placebo through subcutaneous injections on Day 1 and Day 90. Participants will visit the clinic eight times for vaccinations, blood draws, and health checks throughout the study. Blood samples are collected before and after vaccination to assess immune response. Researchers will monitor adverse events, immune responses, and overall health during the study, which continues until the final assessments at Day 1170.

Age: 6Months - 20MonthsAll GendersPhase 3
4 locations
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Actively Recruiting

Researchers are evaluating the effectiveness of claseprubart DNTH103 compared to a placebo in adults with chronic inflammatory demyelinating polyneuropathy CIDP. This Phase 3 study aims to assess treatment outcomes in participants with typical CIDP or certain CIDP variants, focusing on improving disease activity and disability measures. The study consists of several periods Part A includes an open-label phase lasting up to 13 weeks where participants receive an intravenous loading dose of claseprubart followed by subcutaneous injections every two weeks. Part B is a randomized, placebo-controlled, double-blind treatment phase lasting up to 52 weeks for those who respond to treatment in Part A, with participants receiving either claseprubart or placebo subcutaneously every two weeks. Eligible participants may then join an optional open-label extension lasting up to 104 weeks, continuing claseprubart treatment subcutaneously every two weeks, followed by a safety follow-up period of 40 weeks. Participants will undergo regular assessments throughout the study, including evaluations of disease relapse using the Adjusted Inflammatory Neuropathy Cause and Treatment INCAT score, disability scales, grip strength measurements, quality of life, fatigue severity, and antibody levels. Safety monitoring involves tracking adverse events and drug serum concentrations. The total study duration can extend up to approximately 209 weeks, including all treatment and follow-up phases, with careful monitoring of participants neurological stability and treatment responses.

Age: 18Years - 75YearsAll GendersPhase 3
180 locations
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Actively Recruiting

This research aims to compare the effectiveness of two pain relief drugs, mirogabalin and pregabalin, after unilateral primary total knee arthroplasty TKA in adults aged 50 to 85 years. The study evaluates which drug better reduces pain and improves function following knee replacement surgery. It is a randomized controlled trial conducted by Thammasat University Hospital. After surgery, participants are randomly assigned to receive either mirogabalin or pregabalin alongside standard medications. Those in the mirogabalin group take 5 mg tablets twice a day after breakfast and dinner for two weeks. Participants in the pregabalin group take 75 mg tablets once daily before bedtime for two weeks. During the study, participants pain scores will be measured frequently, starting every six hours for two days, then twice daily for two weeks, and weekly up to 12 weeks after surgery. Researchers will also monitor morphine use, knee movement range, knee function scores, sedation levels, incidence of sleepiness and dizziness, and hospital stay length. The total participation lasts up to 12 weeks post-surgery, with regular assessments to track recovery and safety.

Age: 50Years - 85YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating tozorakimab as an additional treatment to standard care in adults hospitalized with viral lung infection who need supplemental oxygen. The study aims to determine if tozorakimab can help prevent death or the need for invasive mechanical ventilation or extracorporeal membrane oxygenation. This Phase III trial involves a large group of participants to assess the safety and effectiveness of this approach. Participants are randomly assigned to one of two groups one group receives a single intravenous dose of tozorakimab on the first day, while the other group receives a matching placebo. The study uses a double-blind design, meaning neither participants nor researchers know which treatment is given. This helps ensure unbiased results. The treatments are given once, and participants continue to receive standard care during the trial. During the study, participants are closely monitored and evaluated up to 60 days after treatment. Researchers track important outcomes such as death rates, progression to invasive ventilation, days alive outside intensive care, and oxygen use. They also assess clinical progression using a World Health Organization scale and monitor for any anti-drug antibodies. The trial lasts until November 2027, with multiple assessments throughout to understand the treatments impact and safety.

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

This research aims to evaluate the effects of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with a systolic blood pressure of at least 130 mmHg, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial focusing on preventing heart failure events and cardiovascular death. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those starting the baxdrostatdapagliflozin treatment may begin with a lower baxdrostat dose that can be increased if certain criteria are met. A run-in period with dapagliflozin alone for 4 to 6 weeks may occur for those not previously treated or treated less than 4 weeks with SGLT2 inhibitors. Treatment visits will occur at about 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months until study closure. Participants will undergo screening for eligibility within a 14-day period, with an optional pre-screening phase that does not require site visits or consent. During the study, regular assessments including monitoring for heart failure events and cardiovascular outcomes will be conducted. If participants stop the blinded treatment early, they may continue with open-label dapagliflozin unless specific discontinuation criteria apply. The study will continue until a predetermined number of cardiovascular events occur, with ongoing data collection and visits according to protocol.

Age: 40Years +All GendersPhase 3
953 locations
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Actively Recruiting

Researchers are evaluating the safety and effectiveness of endovascular therapy compared to medical therapy alone for treating acute ischemic stroke caused by blockage in the M2 segment of the middle cerebral artery. This study is a randomized, controlled trial with open-label treatment and blinded outcome assessment, aiming to improve functional outcomes after stroke. Participants are randomly assigned to receive either endovascular therapy alongside medical treatment or medical treatment alone. The intervention involves initiating endovascular therapy within 30 minutes of randomization. The study includes a 90-day follow-up period to assess recovery and safety outcomes. This trial is conducted after the therapy is already approved for market use. During the study, participants undergo assessments including the modified Rankin Scale to measure functional outcomes at 90 days, neurological evaluation with the NIH Stroke Scale at 48 hours, and imaging to monitor for brain bleeding. Quality of life questionnaires are also completed. Safety is closely monitored for events such as intracranial hemorrhage and death. The total participation time covers up to three months following randomization.

Age: 18Years - 84YearsAll GendersPhase Not Applicable
3 locations