Malmesbury

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 safety and immune response of the MTBVAC vaccine in adolescents and adults aged 12 to 55 years living with and without HIV in South Africa. The study includes participants grouped by HIV status and immune markers, such as CD4 T cell counts and interferon-gamma release assay results. The trial is designed to compare MTBVAC with the BCG vaccine and is conducted as a Phase 2a randomized study without a placebo group. The study is divided into two parts Part A includes two cohorts with four groups each, and Part B includes one cohort with four groups. Participants receive a single 0.1 mL intradermal injection of either MTBVAC or BCG in the upper arm at the start of the study. Enrollment of the third cohort will occur only if safety criteria are met in the first two cohorts. Following vaccination, participants are monitored for 48 weeks. Participants will attend clinic visits for safety assessments and immune response evaluations through blood tests measuring specific immune cells and antibodies at various time points, including weeks 4, 10, 24, and 48. Researchers will track adverse events, vaccine acceptability, and immune system changes by analyzing blood samples and gene expression. The study ensures thorough follow-up to assess both the safety and the bodys immune reaction to the vaccines over nearly a year.

This research aims to compare two asthma inhalers that use different propellants in people with mild to moderate asthma. The study evaluates whether an investigational inhaler with a new climate-friendly propellant, HFA-152a, works as safely and effectively as inhalers using the existing HFA-134a propellant. This global Phase II study plans to enroll 468 patients in Europe, Latin America, Ukraine, South Africa, and the United Kingdom. Participants will use one of three inhaler treatments in a randomized, double-blind crossover design the investigational CHF5993 pMDI with HFA-152a, CHF5993 pMDI with HFA-134a, or CHF718 pMDI with HFA-134a. Each inhaler is taken as two puffs twice daily. The study compares lung function effects of these inhalers during treatment periods. During the trial, participants will be assessed for lung function through measurements like forced expiratory volume in 1 second FEV1 at baseline and after treatment. Researchers will monitor safety, treatment adherence, and asthma control over the study period. Participants undergo scheduled visits for these evaluations, with the study expected to complete in June 2027.

Researchers are evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.