Joliette

Researchers are evaluating the efficacy and safety of elecoglipron, an oral tablet taken once daily, for weight management in adults with obesity or overweight. This Phase III global, randomized, double-blind, placebo-controlled trial includes two independent pivotal studies one in adults without type 2 diabetes T2DM and the other in adults with T2DM, all having at least one weight-related health condition. The goal is to understand how elecoglipron compares to placebo when combined with diet and exercise. Participants will be randomly assigned to receive either one of two doses of elecoglipron or a matching placebo daily. Study 1 involves about 3000 adults living with obesity or overweight without T2DM, while Study 2 involves about 1500 adults with obesity or overweight and T2DM. Both studies last 72 weeks, during which changes in body weight and other health measures will be monitored. During the trial, participants will undergo regular health assessments including measurements of body weight, waist circumference, blood sugar control, blood pressure, and other related health indicators. Researchers will track percent change in body weight from baseline at 72 weeks as the primary outcome. Participants will be monitored closely throughout the study to assess safety and effectiveness of the treatment in managing weight and associated health conditions.

Researchers are evaluating how well once-weekly insulin icodec maintains blood sugar levels compared to daily basal insulin injections in adults with type 2 diabetes. The study focuses on people who need to start basal insulin treatment after using other glucose-lowering medications. This phase 4 trial aims to assess insulin icodecs effectiveness in real-world clinical practice over about 13 months. Participants will be randomly assigned to receive either weekly subcutaneous injections of insulin icodec or daily subcutaneous injections of basal insulin analogues such as insulin glargine, detemir, or degludec. The study compares these two insulin regimens as part of standard type 2 diabetes care. Treatment continues during the 52-week period to monitor blood sugar control and treatment satisfaction. Throughout the study, participants will undergo assessments including measuring changes in glycated hemoglobin HbA1c from baseline to week 52. They will also complete questionnaires on treatment adherence, satisfaction, and burden, and researchers will track severe hypoglycemia episodes and insulin doses. The trial spans about 13 months, providing thorough monitoring of treatment impact and safety in daily clinical use.

Researchers are evaluating the drug orforglipron in people who have obesity or are overweight and also suffer from osteoarthritis OA of the knee with pain. This study aims to assess how well and safely orforglipron works for this group of participants. The trial is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study sponsored by Eli Lilly and Company. Participation in the study will last about 74 weeks. Participants will be randomly assigned to receive orforglipron or a placebo orally. The study includes two independent groups under a master protocol, each comparing orforglipron to placebo. Treatment is given once daily, and the study design is parallel-arm, meaning participants remain in their assigned group throughout the trial. During the study, participants will undergo various assessments including pain evaluation using the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC pain subscale, physical function tests, body weight measurement, health surveys, walking tests, and blood tests for inflammation markers and cholesterol. Safety and drug levels will also be monitored. These evaluations occur from the beginning of the study through week 72, with participant involvement spanning about 74 weeks total.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

This research aims to improve the use of Prison Needle Exchange Programs PNEPs in Canadian federal prisons to help people who inject drugs while incarcerated. The study is conducted in nine federal prisons, including five womens prisons where more individuals report injection drug use. The goal is to identify obstacles and supports to increase PNEP adoption and make these programs more sustainable over time. The study uses a step-wedge design with a Type 2 hybrid implementation trial to evaluate how the Network for the Improvement of Addiction Treatment NIATx strategy bundle affects PNEP uptake over 24 months. Nine prisons are divided into three groups that receive the NIATx intervention in staggered intervals every six months. Each group undergoes a control period, a NIATx intervention period, and then a 12-month maintenance phase to assess how well improvements last. Participants include all people incarcerated at the study sites during the intervention period. Researchers will monitor measures such as the effectiveness of program uptake, bloodborne virus care, and enrollment in opioid agonist therapy throughout the intervention. The study includes ongoing observation during and after the intervention to assess program sustainability, with a total study period extending up to 54 months for some groups.

Researchers are evaluating the value of care received by ambulatory adult patients with acute health concerns such as sore throat, cough, fever, and limb injuries. The study compares care in emergency departments EDs, walk-in clinics WICs, and primary care physician PCP practices, including telemedicine visits, to understand which setting offers the best patient outcomes and cost-effectiveness. This observational research involves multiple centers in Quebec and Ontario and addresses the impact of telemedicine adoption during the COVID-19 pandemic. Participants will receive care either in an ED by physicians unfamiliar with them, in walk-in clinics via in-person or virtual visits, or in primary care clinics where they may see their own or a colleague physician. The study uses a time-driven activity-based costing method to calculate care episode costs, followed by monitoring patients through follow-up phone calls conducted 1-3 days and 8-14 days after the initial visit. These calls gather data on patient experience, outcomes, and costs. During the study, patient data are collected from medical records, provincial databases, and follow-up questionnaires. Researchers will measure patient-reported outcome scores seven days after the visit as the primary outcome, along with experience scores, return visit rates, healthcare costs, hospital admissions, and adherence to care guidelines. The study includes safety monitoring up to 30 days post-visit and aims to help policymakers and providers decide on the most appropriate care setting for ambulatory emergency conditions. The total participation involves at least two follow-up calls after the initial consultation.