Victoriaville

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 investigating the effectiveness and safety of KarXT combined with KarX-EC in treating cognitive problems associated with mild to moderate Alzheimer's Disease. This phase 3 study focuses on patients diagnosed according to the National Institute on Aging and Alzheimer's Association criteria, targeting those with specific dementia stages and confirmed disease pathology. The goal is to assess whether this combination therapy can improve cognitive function in this population. Participants will receive either KarXT and KarX-EC together or a placebo, with doses given on specified days during the study. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active treatment or placebo during the trial. The treatment period lasts up to 24 weeks to evaluate the effects of these medications on cognitive impairment. During the study, participants will be closely monitored through cognitive assessments including the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 and the Clinician's Interview-Based Impression with caregiver input, both measured at 24 weeks. Caregivers play an important role by maintaining regular contact, reporting on the participant's condition, and helping with medication adherence. Safety and cognitive function will be regularly evaluated to understand the impact of the treatment over the study period.

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 effects and safety of AZD6793 tablets in adults aged 40 years and older who have moderate to very severe chronic obstructive pulmonary disease (COPD). This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study involving approximately 1160 participants at around 400 sites worldwide. The study aims to compare three different doses of AZD6793 against placebo tablets over 24 weeks to assess how well the treatment works and its safety profile in this population. Participants will be randomly assigned to one of four groups receiving either one of three doses of AZD6793 or a placebo in equal proportions. The treatment involves oral administration of AZD6793 tablets or placebo tablets daily for 24 weeks. The study is designed with parallel groups and includes careful dose-ranging to evaluate different levels of the investigational drug. During the study, participants will be monitored for the annualized rate of moderate or severe COPD exacerbations from baseline up to 24 weeks. Assessments include lung function tests such as pre- and post-bronchodilator FEV1/FVC ratios, symptom questionnaires like the COPD Assessment Test (CAT), and documentation of COPD exacerbation history. Safety will be continually evaluated through clinical assessments and laboratory tests throughout the treatment period.

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 efficacy, safety, and tolerability of lunsekimig compared with a placebo in adults aged 40 to 80 years who have inadequately controlled Chronic Obstructive Pulmonary Disease (COPD) characterized by an eosinophilic phenotype. This Phase 2b/Phase 3 study focuses on patients with COPD who have specific lung function criteria, prior exacerbations, and blood eosinophil counts, aiming to better manage their condition using a new subcutaneous treatment. Eligible participants will receive subcutaneous injections of either lunsekimig or a matching placebo during a randomized intervention period lasting approximately 48 weeks. The study includes a screening period of up to 4 weeks before treatment and a follow-up period of about 8 weeks after treatment, making the total study duration up to 60 weeks. Participants remain in one of three study arms throughout this timeline. During the study, participants will be monitored regularly to measure the annualized rate of moderate-to-severe COPD exacerbations from baseline up to 48 weeks. Researchers will assess safety, tolerability, lung function, and other health outcomes. The study collects data on participants' lung function, exacerbation frequency, and blood markers, along with adherence to treatment and safety follow-up over the entire study period.

Researchers are evaluating a plant-based seasonal recombinant trivalent virus-like particle (TVLP) influenza vaccine in adults aged 18 years and older, including those 65 years and above. This Phase 1/2 study aims to assess the safety, tolerability, and immune response of this vaccine and to determine the appropriate doses for further development in these age groups. Participants will receive either the plant-based recombinant influenza vaccine or a commercially available influenza vaccine in a randomized, observer-blind format. The study involves dose-ranging to find the optimal dose for adults and older adults. Vaccinations and follow-up visits occur according to the study schedule, with careful monitoring of adverse events and immune responses. Participants will be monitored closely for immediate and delayed adverse effects using clinical assessments, blood tests, urine tests, and questionnaires. The main outcomes include safety evaluations at multiple time points up to 182 days after vaccination and measurement of antibody responses on Day 0 and Day 28. The study includes ongoing communication and multiple visits to ensure participant safety and gather detailed immunogenicity data throughout the study period.

Researchers are evaluating the effects of single and multiple doses of ABCL635, given by subcutaneous injection, in healthy men and postmenopausal women, including those with moderate-to-severe vasomotor symptoms (VMS) related to menopause. This study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ABCL635, as well as its impact on the frequency and severity of VMS in affected postmenopausal women. The study includes both healthy volunteers and women experiencing menopausal symptoms to understand the treatment's effects across these groups. The study has three parts: Part A and Part B are Phase 1 studies involving single ascending doses and multiple ascending doses of ABCL635 or placebo, respectively, given to healthy men and postmenopausal women. Part C is a Phase 2 study where a single dose of ABCL635 or placebo is given to postmenopausal women with moderate-to-severe VMS. After completing Part C, participants may join an open-label extension to receive an additional single dose of ABCL635 following a 12-week evaluation period. Participants will be monitored from day 0 to day 197 for safety outcomes including frequency and severity of adverse events, abnormalities in ECGs, physical examinations, and laboratory tests covering biochemistry, hematology, endocrinology, and urinalysis. The study involves thorough health assessments, breast cancer screening for women, and hormone level checks for men. Researchers will measure how the treatment affects menopausal symptoms and overall participant health throughout the study and extension period.

Researchers are evaluating the effects of Taplucainium Inhalation Powder (NOC-110) in adults aged 18 to 80 who have refractory or unexplained chronic cough lasting at least 12 months. This phase 2b study aims to assess the medicine's efficacy, safety, and tolerability compared to a placebo in a randomized, double-blind, controlled setting. The study will involve about 455 participants, with up to 1264 screened to identify eligible adults. Participants will receive either NOC-110 inhalation powder or a matching placebo once daily during the treatment period. The study includes a screening phase followed by approximately 13 weeks of participation, during which participants will use the assigned inhalation powder. The trial is designed to monitor how the treatments impact cough frequency and overall tolerability over this period. Throughout the study, participants will be closely monitored for changes in their 24-hour cough rates, measured from baseline to the end of treatment. Researchers will also assess safety and any side effects. Participants will provide informed consent and follow contraceptive guidance if applicable. The study includes detailed tracking of medical history, respiratory health, and other relevant factors to ensure participant safety and gather comprehensive data on treatment effects.