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Found 24 Actively Recruiting clinical trials
Actively Recruiting
Researchers are studying a medicine called enlicitide to lower low-density lipoprotein cholesterol LDL-C in people with high cholesterol. This trial aims to learn if enlicitide given with rosuvastatin, a standard cholesterol-lowering treatment, works better than a placebo. The study is a phase 3, randomized, double-blind, placebo-controlled trial evaluating the combinations effect on LDL-C levels in adults with hyperlipidemia. Participants will be assigned to one of four groups enlicitide with a placebo matching rosuvastatin, enlicitide with rosuvastatin, rosuvastatin with a placebo matching enlicitide, or placebos for both drugs. All treatments are taken orally once daily for up to 12 weeks. This setup helps researchers compare the effects of enlicitide alone, rosuvastatin alone, their combination, and placebo. During the study, participants will have their LDL-C levels measured at baseline and at weeks 8 and 12. Researchers will also monitor apolipoprotein B, non-high-density lipoprotein cholesterol, lipoproteina, and adverse events. The main outcome is the percent change in LDL-C at week 8. Safety and tolerability are assessed throughout the treatment and up to about 20 weeks. The total participation duration is up to 12 weeks of treatment with follow-up monitoring.
Actively Recruiting
Researchers are evaluating how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes T2D, lose weight. The purpose of this clinical study is to find out how safe and effective CagriSema is for body weight loss compared to semaglutide, a medicine already prescribed by doctors. This is a Phase 3 randomized trial lasting about 83 weeks. Participants will be randomly assigned to receive either one of two doses of CagriSema or semaglutide, all given once weekly by injection under the skin during a 72-week treatment period. CagriSema is a new medicine being tested, while semaglutide serves as an active comparator. The study compares these treatments for their effects on weight loss and related health measures. During the study, participants will have regular assessments including body weight, body mass index BMI, waist circumference, cholesterol levels, and blood sugar control measured by HbA1c. Researchers will also monitor physical function and quality of life through questionnaires. Safety is tracked by recording any adverse events up to 80 weeks. The main outcome is the change in body weight from the start of treatment to the end of the 72-week period.
Actively Recruiting
Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 bcg on heart and lung outcomes in people with chronic obstructive pulmonary disease COPD who have a higher risk of heart and lung problems. This Phase III study compares this triple therapy to a dual therapy inhaler containing glycopyrronium and formoterol fumarate GFF MDI 14.49.6 bcg. The trial is randomized, double-blind, and conducted at multiple centers to assess which treatment better affects cardiopulmonary outcomes.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the safety, tolerability, and immune response of an intranasal vaccine called BLB-201, which is designed to protect against respiratory syncytial virus RSV infection. This Phase 12a randomized, placebo-controlled trial includes infants aged 8 to 24 months and children aged 18 to 59 months, some of whom may have had prior RSV infection. The study aims to understand how different doses affect these young participants. Participants receive one or two doses of BLB-201 at either a low dose 106 PFU or a high dose 107 PFU given through the nose. Some children receive a placebo, which is a harmless saline solution, to compare effects. The doses are given on Day 1, and for some groups, a second dose is given on Day 57. The study includes groups based on age and prior RSV exposure to assess responses across different participant types. Throughout the trial, participants are closely monitored for any side effects from Day 1 to Day 29, including both expected and unexpected events. The study team also evaluates how well the vaccine triggers the immune system. Caregivers provide consent and ensure their child attends all scheduled visits. The entire study runs until late 2028, allowing researchers to gather thorough safety and immune response data over time.
Actively Recruiting
Researchers are evaluating the medication orforglipron in people who are obese or overweight and have osteoarthritis OA of the knee with pain. The study aims to understand how well and safely orforglipron works for this group. This phase 3 trial is sponsored by Eli Lilly and Company and participation will last about 74 weeks. Participants will be randomly assigned to receive either orforglipron or a placebo, both taken orally. The study includes two independent groups within the protocol, each with an orforglipron and placebo arm. Treatments are given once daily, and the trial is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo during the study. During the study, participants will have regular assessments including pain and physical function evaluations using the WOMAC score, body weight measurements, walking tests, and blood tests for inflammation markers. The main outcome is the change in knee pain from the start to week 72. Safety and drug levels in the blood will also be monitored. Participants may use allowed pain medications, and all assessments will help researchers understand the effects of orforglipron over the study period.
Actively Recruiting
Researchers are evaluating CD388, a long-acting antiviral treatment, to prevent symptomatic influenza infections in adults and adolescents at higher risk for influenza complications. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess how well CD388 works compared to placebo, as well as its safety and tolerability. Participants are randomly assigned to receive either a single dose of 450 mg CD388 or a matching placebo, both given by three subcutaneous injections. The study is conducted across multiple centers and includes participants aged 12 years and older. The trial compares the incidence of influenza-like illness starting from 7 days after dosing up to 24 weeks later. During the study, participants undergo screening tests including rapid antigen tests for influenza and COVID-19 before dosing. Researchers monitor participants for influenza-like illness, collect blood samples at several visits to measure CD388 levels and immune responses, and record any side effects. The overall participation lasts up to about 24 weeks, during which adherence to study procedures and safety are closely followed.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the effectiveness, safety, and tolerability of a vaccine designed to reduce Clostridioides difficile C. difficile infections in adults aged 65 years and older. This phase 3 study compares the vaccine to a placebo in a group of older adults who have recent or planned contact with healthcare systems or recent antibiotic use. The purpose is to understand how well the vaccine works to prevent infections and to monitor any side effects or reactions. Participants will receive either the C. difficile vaccine or a placebo shot injected into the upper arm muscle. The study is randomized, double-blinded, and placebo-controlled. The vaccination period includes two doses and participants will be monitored for up to about three and a half years. Follow-up includes three planned clinical visits and three phone visits initially, then yearly clinic visits until the study ends. Participants are asked to report and save stool samples if they experience three or more loose stools in 24 hours to check for possible infection. During the study, researchers will track local and systemic reactions to the vaccine within seven days after each shot, adverse events up to one month after each vaccination, and serious adverse events for up to 18 months after the last dose. The main measurement is the occurrence of medically attended primary C. difficile infections from two weeks after the second vaccination through the surveillance period. Safety monitoring and annual visits will continue until the study is completed, which could be sooner or later depending on infection rates.
Actively Recruiting
Researchers are evaluating the effectiveness of computerized cognitive training methods to help breast cancer survivors who experience cognitive difficulties related to cancer and its treatments. This trial focuses on breast cancer survivors with non-metastatic disease who report cognitive problems after their cancer therapy, aiming to address the long-lasting challenges that affect their work and health. The study is a Phase III, double-blind, randomized controlled trial comparing two types of cognitive training methods. Participants will be assigned to one of two groups. The first group will use global stimulation games featuring non-speeded, strategy-based exercises like solitaire, sudoku, and word search that do not adapt to the players skill. The second group will use neuroplasticity games designed to improve cognitive functions such as attention, working memory, processing speed, and executive function, with exercises that adapt to the users performance. The training involves eight exercises tailored to address cognitive concerns common among breast cancer survivors. During the study, participants will be monitored over 12 weeks post-randomization for self-reported cognitive impairment, with further assessments extending to 36 weeks. Researchers will collect data through cognitive tests, questionnaires, and behavioral tracking within the programs to measure changes in cognitive performance. The trial will also evaluate the safety and adherence to the training programs, with the total participation period lasting up to 36 weeks from randomization.
Actively Recruiting
Researchers are collecting and storing tissue and blood samples from patients with various types of cancer to help create better models for studying cancer and testing new cancer drugs. This observational study focuses on patients with hematopoietic and lymphatic system neoplasms, malignant solid tumors, metastatic malignant solid tumors, and recurrent malignant solid tumors. The goal is to procure biological tissues and materials to develop preclinical cancer models for future laboratory analysis. During the study, tumor tissue and blood samples are collected during medical procedures required for the patients cancer treatment. These samples are then preserved using methods such as xenograft models, where tissues are transplanted to another species, or in vitro cell cultures. This process allows for future scientific study without additional invasive procedures beyond routine clinical care. Participants will be involved in routine clinical procedures during which tissue and blood samples are collected. Researchers will store these specimens and monitor their use in creating cancer models over a period of up to five years. The main outcome measured is the successful procurement and storage of tissue and blood specimens for research purposes. Participation will continue as long as samples can be collected during clinical management, with no additional treatment or interventions required specifically for this study.
Actively Recruiting
Researchers are studying how well and safely Eloralintide LY3841136, given once weekly, works in adults who are overweight or have obesity and suffer from knee osteoarthritis pain. This study uses a master protocol design to support two independent Phase 3 randomized, double-blind, placebo-controlled trials. It aims to evaluate changes in body weight and knee pain among participants with osteoarthritis and obesity or overweight. Participants will be randomly assigned to receive either Eloralintide or a placebo, both administered by subcutaneous injection. The treatment period lasts about 64 weeks, with dosing occurring once weekly. The study includes a total participation time of approximately 75 weeks, which encompasses screening and follow-up. Both experimental and placebo groups are included to compare the effects of Eloralintide. During the study, participants will undergo assessments including body weight, knee pain scores using the WOMAC pain subscale, physical function, blood pressure, cholesterol levels, inflammatory markers, and walking ability measured by a 6-minute walk test. Researchers will also monitor changes in medication use and safety through regular evaluations. The study collects data from baseline through week 64, with ongoing safety monitoring and outcome measurements throughout the participation period.
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