Penzance

Researchers are studying the safety and effectiveness of brenipatide, given alongside standard treatment, compared to a placebo with standard treatment, to see if it can delay the return of symptoms in adults with major depressive disorder. This is a Phase 3, randomized, double-blind study involving adult participants aged 18 to 75 years. The trial is designed to assess how long it takes for depression symptoms to relapse after starting the adjunctive treatment. Participants will receive either brenipatide or placebo, both administered by subcutaneous injection, in addition to their stable standard of care medication. The study has three main periods: a screening period lasting about one month, followed by a treatment phase of at least 12 months where participants receive the assigned injections, and finally a follow-up period of roughly two months. The total time in the study can be shorter if symptoms worsen or if a participant withdraws. During the trial, participants will need to attend scheduled visits, self-inject the study drug, maintain study diaries, and complete questionnaires. Researchers will monitor participants closely to determine the time until relapse of major depressive disorder symptoms occurs. Safety and adherence to study procedures will be tracked throughout the trial, with the primary outcome measuring the number of days from randomization until relapse.

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.

This research aims to evaluate the gastrointestinal tolerance and acceptability of a high energy, high protein oral nutritional supplement in adults who are malnourished or at risk of malnutrition. It is a multi-center, prospective, non-randomized, non-blinded, single-arm study focusing on adults aged 18 years and older. The study includes participants identified by dietitians or clinicians based on malnutrition risk factors, such as recent weight loss or current use of oral nutritional supplements, with normal gastrointestinal function. Participants will receive a high energy, high protein oral nutritional supplement designed to support their nutritional needs. The study treatment lasts for at least 7 days, during which participants consume the supplement as assessed necessary by a dietitian or clinician. The study does not include a comparison group and focuses on a single treatment regimen during the study period. During the study, participants will be monitored for gastrointestinal tolerance from the first study day through day seven. Researchers will assess how well participants tolerate the supplement and their acceptability of the product. Safety and compliance will be observed through clinical assessments, with attention to any adverse effects or difficulties related to the supplement. The total participation time centers on this one-week evaluation period.

Researchers are evaluating the effects of baxdrostat combined 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 systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.

Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.