Le Creusot

Researchers are evaluating the safety and effectiveness of NNC0487-0111 for treating adults with excess body weight. This phase 3 clinical trial compares weekly injections of NNC0487-0111 against placebo injections, both given under the skin. Participants also follow a reduced-calorie diet and increased physical activity as part of the study. Participants receive subcutaneous injections once a week of either NNC0487-0111 or a placebo. The study uses a randomized, parallel design with quadruple masking to assign treatments by chance. Treatments are given alongside lifestyle changes involving diet and exercise. During the trial, participants will be monitored over 92 weeks with regular assessments including body weight, waist circumference, blood pressure, blood sugar markers, cholesterol levels, and quality of life questionnaires. Safety is evaluated by tracking any adverse events. The primary measurement is the relative change in body weight from week 40 to week 92. The study is sponsored by Novo Nordisk AS and runs until mid-2028.

Researchers are studying maridebart cafraglutide to evaluate its effect on reducing cardiovascular problems and death in people with atherosclerotic cardiovascular disease who are also overweight or obese. This Phase 3 trial compares maridebart cafraglutide to a placebo, both given alongside standard care, to see if maridebart cafraglutide works better in lowering heart-related risks. Participants will receive either maridebart cafraglutide or a placebo, both administered by subcutaneous injection. The study lasts for up to approximately 35 months, during which researchers monitor several heart and health outcomes. These include heart attacks, strokes, death rates, hospitalizations, blood pressure, body measurements, blood sugar control, cholesterol levels, kidney function, and inflammatory markers. During the trial, participants will have regular assessments including physical exams, blood tests, and monitoring of heart events. Researchers track the time to first major heart-related events and changes in health markers over the study period. Safety is also monitored by recording any adverse events. The total participation time can last nearly three years, allowing careful observation of the effects of the study drug compared to placebo.

Charcot foot is a complication of diabetes that causes progressive damage to bones, soft tissues, and tendons in the ankle and foot, often leading to joint dislocation. This condition is not well understood by patients and caregivers, and its non-specific symptoms often result in delayed or missed diagnosis. Researchers are studying a group of patients with chronic Charcot foot in France to assess how quality of life changes over two years and to identify factors that predict worse outcomes among these patients. Participants in this observational study will complete questionnaires including the SF-36, FAAM-F, PHQ-9, PHQ-2, and a simplified EPICES score to evaluate quality of life, foot and ankle function, depression, and social precarity. These assessments will be conducted at the start, after 12 months, and after 24 months. In addition, X-rays will be used to track changes in foot bone and joint deformities. The study will also monitor diabetes complications, medical treatments for Charcot foot, presence of wounds or infections, amputations, hospitalizations, and depression symptoms over the two-year period. Participants will be asked to fill out questionnaires at these three time points and undergo foot X-rays and clinical evaluations to track their condition. Researchers will evaluate results from these questionnaires and imaging studies to understand how quality of life evolves and what factors contribute to outcomes. The study includes a comprehensive assessment of diabetic complications, foot deformities, and mental health. Participants will be followed for two years to gather this detailed information and help improve understanding of chronic Charcot foot.

This research aims to evaluate the effects of combining baxdrostat 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 a systolic blood pressure of at least 130 mmHg, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial focusing on preventing heart failure events and cardiovascular death. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those starting the baxdrostatdapagliflozin treatment may begin with a lower baxdrostat dose that can be increased if certain criteria are met. A run-in period with dapagliflozin alone for 4 to 6 weeks may occur for those not previously treated or treated less than 4 weeks with SGLT2 inhibitors. Treatment visits will occur at about 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months until study closure. Participants will undergo screening for eligibility within a 14-day period, with an optional pre-screening phase that does not require site visits or consent. During the study, regular assessments including monitoring for heart failure events and cardiovascular outcomes will be conducted. If participants stop the blinded treatment early, they may continue with open-label dapagliflozin unless specific discontinuation criteria apply. The study will continue until a predetermined number of cardiovascular events occur, with ongoing data collection and visits according to protocol.

Diabetic foot ulcer DFU is a common and serious complication in people with diabetes, often leading to lower-limb amputation and linked to decreased quality of life and increased health care costs. This research aims to better understand why patients with DFU have a higher risk of premature death, exploring factors beyond cardiovascular disease such as inflammation, infections, and cancers. The study is a prospective, observational, multi-center cohort conducted in France. Adults with diabetes and DFU will be followed for up to 5 years to measure outcomes including mortality rates, causes of death, and prognostic factors. The study will include a 3-year enrollment period starting in 2020. Researchers will also assess changes in health-related quality of life and the economic burden of DFU using healthcare claims data. Participants will be monitored regularly over 5 years or until death. Researchers will collect data on survival without active or recurrent DFU, major limb and vascular events, and overall health status. The study will provide important data on the course of DFU and its impact on patients lives and health care systems.