Newton

Researchers are studying a medicine called enlicitide to reduce low-density lipoprotein cholesterol (LDL-C) in adults with high cholesterol (hyperlipidemia). This trial aims to find out if taking enlicitide together with rosuvastatin, a standard cholesterol-lowering drug, works better than a placebo in lowering LDL-C levels. The study is a Phase 3 trial that is randomized, double-blind, and placebo-controlled to ensure accurate and unbiased results. Participants will receive oral tablets of enlicitide or placebo along with oral capsules of rosuvastatin or placebo. The study compares the effect of enlicitide plus rosuvastatin against placebo to evaluate their impact on LDL-C. The treatment period lasts 8 weeks, during which participants take their assigned medications as directed. During the study, researchers will measure the average percent change in LDL-C from the start of the trial to week 8. Participants will be monitored for safety and any side effects throughout the study. The total participation time includes screening, treatment, and follow-up assessments to evaluate the medicines' effects and safety in adults aged 18 to 64 with hyperlipidemia.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating a vaccine called BLB-201 for respiratory syncytial virus (RSV) in infants and children aged 8 to 59 months. This Phase 1/2a randomized, placebo-controlled trial aims to study the safety, tolerability, and immune response after vaccination. Children included may have had prior RSV infection or not, allowing assessment in both seronegative and seropositive groups. The trial tests two doses of the BLB-201 vaccine: a low dose (10^6 PFU) and a high dose (10^7 PFU). Participants receive either one dose on Day 1 or two doses on Day 1 and Day 57. A placebo group receives a saline solution matching the low dose diluent. The study compares these groups to monitor how the vaccine is handled by the body and whether it produces an immune response. During the study, children are carefully monitored for side effects, including solicited adverse events from Day 1 to 15 and unsolicited events through Day 29. Their health is assessed through medical history, physical exams, and laboratory tests. Researchers track vaccine safety and immune response over the study period, with parents or guardians providing consent and helping with participation. The total study duration and follow-up ensure thorough evaluation of vaccine effects in young children.

Researchers are evaluating the safety and effectiveness of orforglipron, taken once daily, in people who are overweight or have obesity and also suffer from knee osteoarthritis with pain. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to understand how well orforglipron works over about 74 weeks. The study is part of a larger master protocol supporting two independent studies focused on this condition and population. Participants will receive either orforglipron or a placebo, both administered orally. The study compares these two groups in a parallel-arm design to assess treatment effects. The trial includes a long treatment and observation period lasting about 74 weeks to monitor changes and safety outcomes. Throughout the study, participants will be assessed for changes in their knee pain using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, measured at the start and at week 72. Researchers will also monitor the participants' safety and overall health during the trial. The participation duration is approximately 74 weeks, including screening, treatment, and follow-up visits.

Researchers are evaluating how effective, safe, and tolerable a vaccine for Clostridioides difficile (C. difficile) infection is in adults aged 65 years and older. The study focuses on reducing the number of C. difficile infections, which can cause diarrhea, in this older adult population. This is a Phase 3, placebo-controlled, double-blinded, randomized trial involving participants who are at risk because of recent or planned contact with healthcare systems or recent antibiotic use. Participants will receive either the C. difficile vaccine or a saline placebo. Both are given by injection into the upper arm muscle. The study includes 3 planned clinic visits and 3 phone visits initially, followed by yearly clinic visits until the study ends. Participants will remain in the study until enough infection events have occurred—this period may last up to about three and a half years, but could be shorter or longer depending on how quickly events happen or if the study stops early due to clear results. Throughout the study, participants will report any side effects such as local reactions and systemic events for 7 days after each vaccination, and adverse events for up to one month. Serious adverse events are monitored for up to 18 months after the last dose. If participants experience 3 or more loose stools within 24 hours during the study, they must save the next stool and contact the study team for infection testing. This ongoing monitoring helps assess the vaccine's impact on preventing medically attended C. difficile infections over time.

The goal of this trial is to determine the efficacy of advanced cognitive training for cancer survivors suffering from cancer- and cancer-treatment-related cognitive dysfunction. For millions of cancer survivors, cognitive dysfunction is a prevalent, severe, and persistent problem that has long been associated with poor work-related and health-related outcomes. Evidence suggests that a significant subset of breast cancer survivors (BCS) incur cognitive changes that may persist for years after treatment. Unfortunately, the scientific basis for managing these cognitive changes is extremely limited. Available evidence from pilot studies, including our work, suggests that advanced cognitive training, which is based on the principles of neuroplasticity (ability of brain neurons to re-organize and form new neural networks), may be a viable treatment option. However, previous trials to date have been limited by lack of attention-controlled designs, small samples of BCS, or limited outcome measures. Therefore, to overcome limitations of past studies and build on our pilot results, the purpose of this 2-group, double-blind, randomized controlled trial is to conduct a full-scale efficacy trial to compare advanced cognitive training to attention control in BCS.

Researchers are collecting and storing tissue and blood samples from patients with various types of cancer to create models that help study cancer and test new treatments. This observational study focuses on patients with confirmed or suspected cancer diagnoses, including solid tumors and hematologic malignancies, to improve laboratory research and drug development. The study involves obtaining tumor tissue and blood samples during medically necessary procedures related to the patient's cancer treatment. These samples will be preserved using xenograft models (transplantation into another species) or cell cultures for future analysis. Sample collection is timed carefully around treatment cycles to ensure tissue viability. Participants will undergo tissue and blood collection as part of their clinical care, with no additional procedures solely for the study. Researchers will review pathology and flow cytometry reports to confirm viable cancer cells in the samples. The main outcome is the successful procurement and storage of these biological materials for research over a follow-up period of up to five years.

This research aims to evaluate the safety and effectiveness of Eloralintide (LY3841136) in adults who have osteoarthritis knee pain and are either obese or overweight. Conducted under a master protocol supporting two independent studies, the trial focuses on participants with a body mass index of 27 or higher who experience knee osteoarthritis symptoms such as pain and stiffness. The study is a Phase 3 randomized, double-blind, placebo-controlled trial designed to provide clear evidence on this treatment's impact. Participants will receive either Eloralintide or a placebo, both administered by subcutaneous injection once weekly. The study includes a screening phase followed by about 75 weeks of participation. The treatments aim to assess changes in body weight and knee pain severity. The study excludes participants with recent surgeries for obesity, diabetes, active knee infections, recent serious heart events, or recent use of weight loss medications. During the study, participants will be regularly monitored for changes in body weight and knee pain using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale. Researchers will track safety and effectiveness through scheduled visits and assessments over the approximately 75-week period. The trial will help determine if Eloralintide provides benefits in managing osteoarthritis knee pain alongside obesity or overweight conditions.

Researchers are evaluating the effectiveness and safety of GL0034 in adults with type II diabetes who are overweight or obese and have related health conditions. This phase II, randomized, double-blind, placebo-controlled study aims to compare various doses of GL0034 against a placebo to understand its impact on blood sugar control, specifically measuring changes in HbA1c levels over 36 weeks. Participants will receive weekly subcutaneous injections of GL0034 at one of six dose levels or a placebo following an initial dose titration period that can last up to about 20 weeks. The study includes multiple treatment arms and a placebo arm, with dosing maintained once a week throughout the study. During the 36-week treatment period, participants will undergo blood tests to monitor HbA1c and other health indicators. They will also perform home blood glucose monitoring and use an electronic device to record their responses. Researchers will track safety and tolerability while assessing changes in blood sugar control from the start to the end of the study.

Researchers are studying the effectiveness and safety of KAI-9531, a drug given as a once-weekly subcutaneous injection, in adults living with obesity who do not have diabetes. The study aims to show that KAI-9531 leads to greater weight loss compared to semaglutide, another injection given weekly, and a placebo. This is a Phase 3 randomized, partially-blinded trial that compares these treatments in people with a body mass index (BMI) of 35 kg/m² or higher who have tried and failed to lose weight through diet and exercise within the last six months. Participants will be assigned to receive either KAI-9531, semaglutide, or a placebo, all administered by subcutaneous injection once a week. The study will monitor changes in body weight over a period of 76 weeks to assess which treatment is more effective. The trial design includes active and placebo-controlled groups to carefully evaluate the impact of KAI-9531 on weight management. During the study, participants will undergo assessments to measure their body weight and other health parameters at baseline and throughout the 76-week period. The main outcome being measured is the percent change in body weight from the start of the study to week 76. Safety and tolerability of the treatments will also be monitored. Participants will be followed closely to ensure adherence and to track any side effects or changes in health status throughout the study duration.