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Found 6 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating eloralintide, a drug given once weekly, in adults who have persistent obesity or are overweight, including those with or without type 2 diabetes. The study focuses on people who are already on stable incretin therapy, aiming to compare the effects and safety of eloralintide to a placebo over about 80 weeks. This phase 3 trial is sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive one of four different doses of eloralintide or a placebo, all administered by subcutaneous injection. The treatment period involves weekly dosing, continuing through the study duration. The study uses a double-blind design, meaning neither participants nor researchers know who receives the drug or placebo. The main goal is to measure changes in body weight from the start to week 64, along with other health indicators. Throughout the study, participants will undergo various assessments including measurements of waist circumference, blood pressure, fasting glucose, insulin levels, and inflammatory markers. They will also complete questionnaires about their quality of life and eating behaviors. Researchers will monitor medication use and drug levels in the body to understand how eloralintide behaves. The total participation time is about 80 weeks, with safety and efficacy evaluations at regular intervals.

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

Researchers are studying whether enlicitide decanoate is safe and effective for treating children and adolescents aged 6 to 17 years with heterozygous familial hypercholesterolemia HeFH, a condition causing high levels of LDL cholesterol in the blood. The study aims to understand how enlicitide behaves in the body over time, how well children tolerate it, and whether it lowers cholesterol better than a placebo. Participants receive enlicitide decanoate orally once daily at doses based on their age. The study includes a short initial treatment of up to 2 weeks, followed by a longer treatment of up to 24 weeks comparing enlicitide to placebo. Those who complete the initial parts may join an open-label extension receiving enlicitide for up to 3 years. During the study, participants undergo blood tests to measure cholesterol levels and the amount of drug in their blood at designated times. Researchers monitor safety by tracking side effects and whether participants discontinue treatment due to adverse events, with follow-up lasting up to about 188 weeks. The study assesses changes in LDL cholesterol and other blood lipids, as well as carotid artery thickness, to evaluate effects over time.

Age: 6Years - 17YearsAll GendersPhase 2Phase 3
40 locations
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Actively Recruiting

Researchers are evaluating how well elritercept works to improve anemia in adults with myelofibrosis MF who are already taking ruxolitinib. The study compares elritercept to a placebo and aims to see if elritercept can reduce tiredness, improve MF-related symptoms, and help participants perform physical activities more easily. It also looks at elritercepts effects on bone marrow, spleen size, antibody development, and long-term safety. Participants receive either elritercept or a placebo by subcutaneous injection once every 4 weeks during a 36-week double-blinded treatment period. The starting dose of elritercept is 3.75 mgkg, with a possible increase to 5.0 mgkg after the second cycle based on response and safety. After 36 weeks, participants who took placebo may switch to receive elritercept in an extended open-label phase. During the study, participants undergo assessments including blood transfusion independence, symptom and fatigue questionnaires, spleen imaging, and bone marrow evaluation. Researchers monitor safety, antibody formation, and survival for up to 7 years. The main outcome is the proportion of participants who become independent from red blood cell transfusions for at least 12 consecutive weeks during the 36-week treatment. Participants are involved in regular visits and evaluations throughout the treatment and follow-up periods.

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

Researchers are studying finerenone, a drug under development, to treat newborns, children, and young adults with heart failure caused by left ventricular systolic dysfunction LVSD. LVSD weakens the left side of the heart, making it hard to pump blood properly, which can cause symptoms such as shortness of breath, tiredness, and poor growth. This Phase 3 study aims to evaluate the long-term safety and effects of finerenone when added to standard heart failure treatment in this young population, including those rolling over from a previous study and newly enrolled newborns under 6 months old. Participants will receive finerenone treatment for up to 9 months, alongside their usual heart failure care. The study will follow them for around 10 to 11 months, depending on their enrollment status. During this time, they will attend at least six visits where the study team will monitor vital signs, take blood samples, perform physical exams, and use heart imaging tests like electrocardiograms and echocardiography. Parents or guardians will also provide feedback on medication use and, for newborns and infants, on the drugs formulation acceptability. Throughout the study, researchers will track any medical problems that arise, changes in blood potassium levels, blood pressure, and kidney function. They will also measure heart function and levels of NT-proBNP, a marker related to heart failure. After finishing treatment, participants will have a follow-up health check one month later. This careful monitoring helps the team understand the safety and effects of finerenone in children and young adults with heart failure and LVSD.

Age: 0 - 18YearsAll GendersPhase 3
132 locations
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Actively Recruiting

Researchers are investigating a new treatment for children with heart failure and left ventricular systolic dysfunction LVSD, a condition where the heart cannot pump enough blood. This study aims to find out if finerenone, a drug that blocks a protein involved in heart and blood vessel damage, can help improve heart function compared to a placebo. This is the first study to test finerenone specifically in children with these heart problems. Participants aged 6 months to less than 18 years with heart failure and LVSD will be randomly assigned to receive either finerenone or a placebo for about 3 months, while continuing their usual heart failure care. After this period, those who qualify can join a 9-month open-label extension where everyone receives finerenone. Participants not joining the extension will have a follow-up visit 30 days after their last treatment. During the study, children will visit the study site at least three times for physical exams, heart tests like ECG and echocardiogram, blood pressure and vital sign checks, blood samples, and medication and side effect reviews. Researchers will measure changes in NT-proBNP, a protein indicating heart stress, and monitor safety through tracking adverse events and other heart and kidney function tests. The total participation can last up to approximately one year including the extension phase.

Age: 6Months - 17YearsAll GendersPhase 3
133 locations
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Actively Recruiting

Diffuse large B-cell lymphoma DLBCL is a fast-growing and uncommon cancer affecting certain immune cells, and it is the most common type of non-Hodgkin lymphoma. Follicular lymphoma FL is a slower-growing form of non-Hodgkin lymphoma. This research aims to evaluate how well the investigational drug epcoritamab works in adults with advanced DLBCL and FL in real-world medical settings. Participants will receive epcoritamab as prescribed by their doctors following local country guidelines. The study will include about 700 adults treated across roughly 80 sites in 12 to 20 countries. Treatment is given as subcutaneous injections, and the study observes participants over up to three years to gather effectiveness information. During the study, participants will continue their regular hospital or clinic visits as part of their usual care, without extra procedures or visits added by the trial. Researchers will monitor the percentage of participants who achieve an overall response to the treatment over approximately three years. The study is observational, meaning it follows patients receiving epcoritamab under normal clinical practice without altering their care.

Age: 18Years +All Genders
73 locations