Whitchurch Stouffville

Researchers are evaluating the effect of baxdrostat combined with dapagliflozin compared to baxdrostat with placebo on reducing albuminuria in people with chronic kidney disease (CKD) and high blood pressure. This Phase IIb, randomized, multicenter, double-blind study includes adults aged 18 years and older, with or without type 2 diabetes and regardless of current SGLT2 inhibitor treatment. The study aims to assess both the impact on albuminuria and the safety of these treatments. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or baxdrostat with a matching placebo. The study includes an optional pre-screening period to assess kidney function and other health markers, and those on SGLT2 inhibitors will undergo a washout before starting treatment. Randomization will consider diabetes status to ensure balanced groups. During the study, participants will be monitored up to 12 weeks to measure changes in albuminuria, specifically urinary albumin-to-creatinine ratio (UACR). Safety and other health parameters will also be assessed through blood tests and blood pressure measurements. The study ends when the last participant completes their final visit and procedures, ensuring thorough data collection on treatment effects and safety.

This research aims to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and its safety and effectiveness in adults with Irritable Bowel Syndrome-Diarrhea (IBS-D). The study focuses on participants who meet specific IBS-D criteria related to bowel movement patterns and abdominal pain. It is a Phase 2, randomized, double-blind, placebo-controlled trial lasting approximately 35 weeks. Participants will receive either brenipatide or a placebo, both administered under the skin through subcutaneous injection. The treatments are compared to assess their impact on IBS-D symptoms. The study involves careful monitoring of patients' responses to the medication over the treatment period, with no changes in diet allowed in the four weeks before screening. During the study, participants will track their symptoms daily using an electronic diary, including abdominal pain and stool consistency. Researchers will measure the percentage of days participants have a positive composite response between weeks 9 and 16. Safety and side effects will be monitored throughout the study, ensuring participants are closely observed during the full duration of about 35 weeks.

Researchers are evaluating the safety, reactogenicity, and immune response of a vaccine called monovalent mRNA-1982 designed to prevent Lyme disease in healthy adults aged 18 to 70 years. This is a Phase 2 randomized, observer-blind, dose-finding, placebo-controlled clinical study focused on determining the best dose and monitoring reactions to the vaccine. Participants will receive either the mRNA-1982 vaccine or a placebo, both given as injections. The study is designed to compare these two groups to assess the vaccine's safety and immune effects. The research includes careful monitoring of local and systemic reactions after the injection, as well as longer-term safety observations. During the study, participants will be monitored for adverse reactions from the day of injection up to 7 days for local and systemic reactions, 28 days for unsolicited adverse events, and up to 21 months for medically attended and serious adverse events. Safety, reactogenicity, and immunogenicity are the main outcomes measured throughout the study period. Participants will undergo medical evaluations including medical history and physical exams at screening to ensure eligibility and safety.

Researchers are evaluating the safety, tolerability, and immune response of a fifth dose of the 6-valent OspA-based Lyme disease vaccine called VLA15 in healthy individuals aged 7 years and older. This Phase 3, randomized, placebo-controlled, double-blinded study aims to understand the effects of an additional vaccine dose on protection against Lyme disease and to monitor for any adverse reactions or new medical conditions. Participants will be randomly assigned in a 5:1 ratio to receive either one dose of VLA15 or a saline placebo injection in the upper arm during the first clinic visit. The study involves about 1712 participants who have previously received four doses of VLA15 and had blood samples taken after the fourth dose. The total study duration is approximately 12 months, during which participants will attend four scheduled clinic visits. Throughout the study, participants will undergo health checks and provide small blood samples. Researchers will monitor for local and systemic reactions within 7 days after vaccination, adverse events up to one month post-vaccination, and any serious adverse events or newly diagnosed chronic medical conditions through the entire study period. Immune responses to the vaccine will be measured one month after the fifth dose. Safety will be overseen by an independent data monitoring committee.

Researchers are evaluating the safety, tolerability, and effects of AZD9550 alone and in combination with AZD6234 in people who are overweight or living with obesity, with or without type 2 diabetes (T2DM). This Phase I/II study includes participants aged 18 to 65 years for most parts and up to 75 years in some parts. The study aims to understand how AZD9550 is absorbed, distributed, and eliminated in the body and to assess safety when given alone or with AZD6234, especially in those with T2DM and obesity or overweight. The study is divided into multiple parts with different dosing schedules: Parts A-D investigate AZD9550 alone with doses increasing weekly or every few weeks; Part E studies the combination of AZD9550 and AZD6234 with increasing doses every 2 to 4 weeks; and Part F examines different ways to increase AZD9550 doses in participants without T2DM. Placebo injections matching the active treatments are used for comparison. Treatments are given as weekly subcutaneous injections. Participants will be closely monitored through various assessments including vital signs, ECGs, laboratory tests, and safety evaluations from screening until Day 261. Researchers will measure the number and percentage of participants experiencing adverse events, changes in lab or heart monitoring results, and the pharmacokinetics of AZD9550 such as concentration and elimination over time. The study also tracks tolerability and any treatment-related effects throughout the study duration.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

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.