Truro

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 the effect of AZD6793, an oral medication, in adults with moderate to very severe chronic obstructive pulmonary disease COPD. This Phase IIb, randomized, double-blind, placebo-controlled study involves approximately 970 participants across about 350 global sites. The trial aims to compare the efficacy and safety of two different doses of AZD6793 against placebo over a 24-week period. Participants will be randomly assigned to one of three groups receiving either dose 1 of AZD6793, dose 2 of AZD6793, or a matching placebo tablet. The study medication is taken orally and the trial lasts for 24 weeks. The study is designed as a parallel-group format with a 111 allocation ratio among the three arms. During the study, participants will be monitored through various assessments including lung function tests measuring forced expiratory volume FEV1, questionnaires evaluating breathlessness, cough, sputum, and quality of life, and tracking of COPD exacerbation events. Blood samples will be collected to measure plasma concentrations of AZD6793. Safety and efficacy outcomes will be evaluated up to 24 weeks, with the main outcome being the rate of moderate or severe COPD exacerbations.

This research aims to evaluate the safety and reactions caused by the mRNA-1469 vaccine designed to prevent Ebola-Bundibugyo Virus Disease in healthy adults aged 18 to 65. The study is a Phase 1 trial sponsored by ModernaTX, Inc., focusing on understanding local and systemic adverse reactions, as well as immune response, to this vaccine. Participants include adults in good health or with stable chronic conditions, with a body mass index between 18.5 and 39 kgm2. Participants will be randomly assigned to receive a single injection on Day 1 of either one of three dose levels of the mRNA-1469 vaccine or a matching placebo injection. The study uses a quadruple masking design to compare the effects across six groups three experimental vaccine dose levels and three placebo groups. The trial includes follow-ups extending up to 337 days to monitor safety and immune response. During the study, participants will be monitored for various outcomes including local and systemic reactions during the first 7 days after injection, any adverse events up to 28 days, medically attended adverse events for 6 months, and serious adverse events or events leading to discontinuation throughout the study. Immune response is assessed by measuring specific antibodies at Day 29 and through Day 337. The total participation time can last nearly 11 months with regular safety checks and laboratory assessments.

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.