Joliette

Researchers are evaluating how well the approved weekly injectable insulin icodec controls blood sugar levels compared to daily injectable basal insulins in adults with type 2 diabetes. This Phase 4 study focuses on people who need to start basal insulin treatment and have had type 2 diabetes for at least 180 days. The goal is to understand the effectiveness of once-weekly insulin icodec against standard daily basal insulins in real-world clinical practice over about 13 months. Participants will receive either insulin icodec once a week or one of the daily basal insulin analogues, such as insulin glargine, insulin detemir, or insulin degludec. Both treatments are given by subcutaneous injection. The choice between weekly or daily insulin is based on current treatment standards for type 2 diabetes. The study lasts approximately 52 weeks, during which participants maintain their assigned insulin regimen. During the study, researchers will monitor changes in participants' blood sugar control using the glycated hemoglobin (HbA1c) test from the start until week 52. Participants will have their HbA1c measured within 90 days before starting the treatment. Safety and any reactions to the insulin will also be tracked. The study aims to assess how well the weekly insulin icodec works compared to daily basal insulins in managing blood sugar over a year.

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.

This research aims to evaluate the effectiveness and safety of different dose escalation plans of retatrutide in adults who are overweight or have obesity but do not have type 2 diabetes. The study focuses on participants with specific weight-related health conditions or a history of unsuccessful weight loss attempts. This is a Phase 3b, randomized, controlled, double-blind trial designed to compare multiple dose strategies. Participants will receive retatrutide, a drug given by subcutaneous injection. The study investigates various dosing schedules to understand how different dose escalations impact safety and efficacy in managing weight. The intervention period includes dose escalation schemes to determine the optimal approach for this population. Participants will be involved for about 113 weeks, during which their body weight will be regularly monitored, with the primary measurement being the percent change from baseline to week 104. Throughout the study, safety and health parameters will be assessed to ensure participant well-being and to track the drug's effects. This long-term follow-up allows researchers to evaluate the sustained impact of retatrutide on body weight and safety over time.

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 effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

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 improve the use of Prison Needle Exchange Programs (PNEPs) in Canadian federal prisons, focusing on people who inject drugs while incarcerated. The study involves nine federal prisons, including five women's prisons where more individuals report injection drug use. The goal is to increase program adoption and sustainability by identifying what helps and hinders participation and implementing strategies based on evidence. The study uses a step-wedge design over 24 months, with nine prisons divided into three groups that receive the intervention at staggered intervals every six months. The intervention involves the Network for the Improvement of Addiction Treatment (NIATx) model, which uses expert coaching and quality improvement tools aimed specifically at behavioral healthcare settings to enhance access and retention. After the intervention period, there is an additional 12-month phase to assess how well the program is sustained. Participants include all people incarcerated at the study sites during the intervention period. Researchers will observe changes in PNEP uptake throughout the study and monitor the effectiveness of the NIATx strategy in improving program engagement. The study also assesses sustainability of the needle exchange programs after the intervention ends, with no exclusions at the participant level since the intervention is applied site-wide.

Researchers are comparing the value of care received in emergency departments, walk-in clinics, and primary care physician practices for ambulatory patients aged 18 and older with various acute health concerns. These include symptoms such as acute diarrhea, sore throat, nasal congestion, earache, shortness of breath, cough, muscle aches, anosmia, dysgeusia, urinary symptoms, limb injuries, back pain, and fever. The study evaluates care from both patient and healthcare system perspectives, especially in the context of increased telemedicine use during the COVID-19 pandemic. The study involves recruiting eligible patients either in person or via telemedicine at one of 14 sites in Quebec and Ontario. Recruitment is done by trained research assistants who screen patients based on specific complaints and obtain consent. Participants receive follow-up phone calls at 1-3 days to collect demographic and motivation data, and again at 8-14 days to measure patient-reported outcomes, experiences, and costs. A time-driven activity-based costing method is applied to calculate the costs associated with each care episode. Participants will be monitored through medical records, provincial databases, and follow-up questionnaires to assess outcomes such as patient-reported outcome scores, experience scores, costs borne by patients, return visits within 3 and 7 days, mortality, hospital admissions, intensive care placements within 30 days, and adherence to practice guidelines. The study aims to provide evidence for policymakers, patients, and providers to determine the most appropriate care setting for managing ambulatory emergency conditions based on value.