Le Creusot

Researchers are evaluating the safety and effectiveness of a medicine called NNC0487-0111 for adults with excess body weight, specifically targeting obesity. This Phase 3 clinical study aims to see if this treatment helps people maintain their weight loss compared to a placebo, which contains no active medicine. Participants are randomly assigned to either the treatment or placebo group to fairly compare results. The study involves two groups receiving weekly injections under the skin: one group gets NNC0487-0111, and the other receives a placebo designed to look the same. The treatment is given once a week, and participants reach a target dose during an initial run-in period before the main study phase begins. During the study, researchers track changes in body weight from week 40 to week 92 to assess how well the treatment works. Participants' safety and health are monitored throughout the study, including various medical assessments. The total participation time covers these weeks and includes ongoing observation to understand the treatment's effects over time.

Researchers are evaluating maridebart cafraglutide, a drug given as an addition to standard care, to see if it reduces heart-related problems and deaths better than a placebo in people with atherosclerotic cardiovascular disease who are overweight or obese. This phase 3 study focuses on cardiovascular events such as heart attacks, strokes, and deaths related to heart conditions, aiming to improve outcomes in this high-risk population. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study compares these two groups over a period of up to approximately 35 months, monitoring heart-related health events to assess the drug's impact. The placebo group will receive injections that look identical but contain no active drug, ensuring a double-blind study design. During the study, participants will be regularly evaluated for major cardiovascular events, including heart attack, stroke, heart failure, and death. Researchers will track the time until these events occur to measure the drug's effectiveness. Safety and health will be closely monitored throughout the study period, and participants will be followed for up to nearly three years to gather comprehensive data on cardiovascular outcomes and overall survival.

Researchers are evaluating the safety and effectiveness of the MEDTRUM Hybrid Closed Loop (HCL) System in children, adolescents, and adults aged 7 to 75 years with type 1 diabetes. The study aims to determine whether the Hybrid Closed Loop system is better at increasing the time spent in the target glucose range of 70-180 mg/dL compared to the manual Open Loop system. Participants will be trained on using the MEDTRUM A8 TouchCare Insulin Management system and randomized into either the Closed Loop or Open Loop group. They will also respond to self-administered questionnaires about hypoglycemia fear, quality of life, and treatment satisfaction. Participants will use either the MEDTRUM A8 TouchCare system in manual mode, where the Hybrid Closed Loop algorithm is not activated, or in automatic mode, where the Hybrid Closed Loop algorithm is activated. The system includes a patch pump, reservoir patches, continuous glucose monitoring with a glucose sensor and transmitter, a personal diabetes manager or app, and related software for tracking and managing glucose levels. The study will last six months, with participants using their assigned system during this time. During the study, researchers will monitor the time spent in the target glucose range during the last 12 weeks and compare results between the two groups. Participants will complete questionnaires on hypoglycemia fear, diabetes quality of life, and treatment satisfaction. Safety and effectiveness will be assessed through glucose monitoring and self-reported outcomes. The total participation duration is six months, with evaluations occurring at the end of this period.

Charcot foot, a complication of diabetes involving progressive damage to bones, soft tissues, and tendons with joint dislocation in the ankle and foot, is not well understood by patients and caregivers. This condition often goes undiagnosed or is diagnosed late due to non-specific clinical signs. The study focuses on a prospective multicenter cohort in France to evaluate how quality of life changes over two years in patients with chronic, wound-free Charcot foot and to identify factors that predict worse outcomes in this population. Participants with chronic Charcot foot will complete several questionnaires including the SF-36, FAAM-F, PHQ-9, PHQ-2, and a simplified EPICES score. These tools aim to assess various aspects of health and quality of life. The study will track patient responses over two years to understand how their condition evolves without wounds and how it impacts their daily functioning and well-being. Throughout the study, patients will fill out these questionnaires at inclusion and follow-up visits. Researchers will analyze the results at the start, 12 months, and 24 months to measure changes in quality of life and foot and ankle functionality. This approach will help capture the progression of symptoms, any deformities, and the effect of comorbidities or diabetic complications. Participants will be monitored for two years to gain insight into long-term outcomes.

Researchers are evaluating the effects of baxdrostat combined with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.

Diabetic Foot Ulcer (DFU) is a serious complication seen in people with diabetes, often leading to non-traumatic lower-limb amputation and linked to cognitive decline and lower quality of life. Despite advances in medical care, patients with DFU face a higher risk of early death, which may be due to factors beyond cardiovascular disease, such as inflammation, infections, and cancers. This research aims to be the first prospective, observational, multi-center cohort study in France to explore the 5-year mortality rate and its causes among patients with DFU, along with identifying important factors that predict outcomes. The study will include adults with diabetes who have a foot ulcer or an open lower-limb amputation wound caused by diabetic complications. Participants will be enrolled over a 3-year period starting in 2020 and followed for up to 5 years or until death. This observational study will use data from multiple centers across France and will also evaluate changes in health-related quality of life and the economic impact of DFU on the French healthcare system by using national claims databases. During the study, participants will be monitored for their health status, including the risk of diabetic foot ulcer recurrence or worsening, and causes of death over five years. Researchers will collect data on quality of life and healthcare costs to better understand the burden of DFU. The primary outcome measured will be the DFU risk score assessed 5 years after inclusion, providing insights into prognosis and factors influencing survival and health outcomes in this population.