Guelph

Researchers are evaluating the safety and effectiveness of NNC0487-0111 for people with excess body weight and knee osteoarthritis. This Phase 3 study compares NNC0487-0111 to a placebo, a treatment with no active medicine, to see if it helps reduce weight and knee pain. Participants have knee osteoarthritis diagnosed by specific clinical and radiographic criteria and experience ongoing knee pain. Participants receive weekly injections under the skin using a pre-filled pen injector. The injections, either NNC0487-0111 or placebo, are given in the thigh, abdomen, or upper arm. The study treatments include two dose levels of NNC0487-0111. Treatment assignment is randomized and blinded, meaning participants receive either the medicine or placebo by chance, not by choice. During the study, participants will be monitored for changes in body weight and knee pain using a standardized pain questionnaire over about 80 weeks. They will follow specific instructions about pain medication before assessments. Researchers will track treatment effects, safety, and any side effects throughout the study period.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the safety and effectiveness of eloralintide, a drug given by injection, in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 study includes both a main phase and an extension phase to understand the drug's impact on body weight and overall health in this population. The study aims to compare eloralintide with a placebo to see how well it works in reducing weight. Participants will receive either eloralintide or a placebo, both administered under the skin once a week. The main study phase will last about 75 weeks, during which participants will be regularly monitored. Those participants who have prediabetes will have the option to continue into an extension phase lasting an additional 2 years to further assess long-term effects. During the study, participants will have their body weight measured at the start and throughout the trial, with the primary outcome being the percent change in body weight at week 64 compared to baseline. Researchers will also monitor safety and any side effects. Participants will be asked about their weight history and health conditions, and they must maintain stable body weight before joining. The total involvement time for most participants will be about 75 weeks, with longer follow-up for some.

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.

Researchers are evaluating an online sexual assault resistance program called IDEA3, designed for undergraduate women aged 17 to 24. Sexual violence is common among college women, with about 40% experiencing assault during their studies. The study aims to test whether the internet-delivered IDEA3 program can reduce sexual violence victimization over a 12-month period. IDEA3 builds on a proven in-person program that reduced sexual assault rates by about 50% in young women. The study compares two groups of participants. Those in the intervention group attend four 3-hour online group sessions of the IDEA3 sexual assault resistance program, which teaches skills to recognize and respond to risky situations, overcome emotional barriers, use effective verbal and physical self-defense, and explore sexual values and boundaries. The control group participates in a single 60-minute virtual consent workshop about understanding and giving consent. Both groups complete surveys. Participants will be followed for one year after randomization. Researchers will collect information on sexual assault experiences at baseline, 1 week after the intervention, and at 6 and 12 months afterwards. The study measures completed rape as the primary outcome to assess the program's impact. Participants are matched in pairs and attend scheduled sessions together, with ongoing surveys throughout the study period.

Researchers are evaluating how psychotherapy works for children and adolescents aged 8 to 15 who experience anxiety, depression, trauma, or disruptive behavior. The study aims to understand whether the regulation of negative emotions is a key factor that influences how well children respond to therapy. This study focuses on biobehavioural regulation of emotion as a potential common mechanism across these mental health conditions. Participants will be randomly assigned to either a flexible, evidence-based therapy called the Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems (MATCH-ADTC) or a waitlist control group. MATCH-ADTC includes 33 treatment modules tailored to address the child’s primary issues and any additional concerns. The treatment is personalized for each child and delivered by trained clinicians. Both groups will undergo baseline assessments, weekly symptom tracking and medication monitoring, and quarterly evaluations every three months. After the treatment or waitlist period, post-test assessments are completed. Children and their parents will take part in various assessments including symptom questionnaires, clinical interviews, experimental tasks, and physiological measurements like heart rate and skin conductance. These evaluations will be conducted before, during, and after the intervention or waitlist period, which typically lasts about four to six months. Researchers will measure changes in child psychopathology symptoms, emotional and behavioral problems, impairment, emotion regulation, and physiological responses to better understand treatment effects and mechanisms.

Researchers are evaluating how a healthy beef-centric diet compares to a healthy U.S.-style dietary pattern in affecting inflammation and other metabolic health outcomes in adults with metabolic syndrome and/or pre-diabetes. The study aims to understand whether focusing on beef as the main protein source can influence glycemic control, inflammation, lipid risk factors, and overall quality of life over a 5-week period. Participants will follow either a healthy beef-centric diet where 70% of daily energy comes from beef, with the remainder from other protein and fats plus low-carb fruits and vegetables, or a healthy U.S.-style diet based on USDA guidelines emphasizing a balanced intake of fruits, vegetables, whole grains, lean proteins, and low-fat dairy. The beef-centric diet excludes grains and is low in carbohydrates but slightly higher than a ketogenic diet. Both diets will be followed during the 5-week intervention period. During the study, participants will be monitored through assessments measuring inflammation levels and metabolic health factors from baseline to week 5. Researchers will track changes in markers such as blood tests and questionnaires related to quality of life. The study collects data on diet adherence and metabolic markers to evaluate the effects of the diets on inflammation and metabolic syndrome characteristics.

Researchers are studying the effects of the Feel Free4 Classic Tonic on stress in healthy adults aged 21 to 55 years. This randomized, double-blind, placebo-controlled trial aims to evaluate how two different doses of the tonic influence self-reported and physiological stress and anxiety levels. Additionally, a pharmacokinetic sub-study will examine how the tonic's ingredients, including kava and kratom, are absorbed and processed in the body. The tonic is traditionally used for relaxation and mood support and is thought to be generally well tolerated. Participants will be randomly assigned to one of three groups: a placebo group, a full-strength tonic group (TP1), or a half-strength tonic group (TP2). The study will monitor changes over 29 days, focusing on stress reduction and the body's response to the tonic. The pharmacokinetic sub-study involves repeated blood draws and video conference visits. Participants are expected to follow specific lifestyle and treatment restrictions throughout the study period, including abstaining from nicotine, alcohol, and other related products. During the study, participants will complete questionnaires such as the Perceived Stress Scale-10 (PSS-10) to measure changes in stress from baseline to day 29. Researchers will also monitor physiological measures and collect safety laboratory tests, including liver enzyme levels. Participants will be asked to maintain consistent dietary and lifestyle habits and comply with contraceptive and other study-specific restrictions. The study includes safety monitoring and requires participants to be able to understand and complete study procedures over the entire duration.

Researchers are investigating how partial sleep deprivation affects cardiac output and blood pressure during cycling exercise in young healthy adults aged 18 to 50 years, including both males and females. The study focuses on understanding whether decreases in plasma volume contribute to lower cardiac output and blood pressure after a night of reduced sleep. Additionally, it aims to explore differences between males and females in these responses. Participants will complete three visits: the first to measure aerobic fitness and establish exercise intensity, and two randomized testing visits after nights of normal sleep and partial sleep deprivation (about 40% of normal sleep duration). During testing, participants will perform a 60-minute cycling exercise while researchers measure blood pressure, stroke volume, cardiac output, and plasma volume. Blood samples will be collected via intravenous lines to support these assessments. Throughout the study, participants will keep daily diaries of their sleep and food intake and wear wrist devices to monitor sleep before testing visits. The researchers will compare cardiac output responses during cycling between normal sleep and partial sleep deprivation over approximately three weeks. Safety and adherence to protocols will be closely monitored throughout the study period.