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Researchers are evaluating the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults with Type 2 Diabetes Mellitus T2DM who are already being treated with insulin and other glucose-lowering medications. This Phase III study focuses on adults with T2DM who have had the condition for at least 90 days and meet certain health criteria. Participants will be randomly assigned to one of three groups elecoglipron at dose level 1, elecoglipron at dose level 2, or placebo. All treatments are taken orally once daily. The study treatment period lasts up to 40 weeks, during which participants continue their background insulin and glucose-lowering medications. During the study, participants will have regular assessments to monitor changes in blood sugar control, including Hemoglobin A1c HbA1c, body weight, blood pressure, and insulin dose. Researchers will also track safety, side effects, and tolerability. The main outcome is the change in HbA1c from baseline to Week 40. Overall, participation involves visits for monitoring and evaluations over approximately 40 weeks.

Researchers are evaluating the efficacy, safety, and tolerability of combining elecoglipron and dapagliflozin compared to each drug alone in adults with type 2 diabetes mellitus T2DM who have not achieved adequate control through lifestyle changes or other glucose-lowering medications. This Phase III study aims to better understand how these treatments work together in managing blood sugar levels in this population. Participants are randomly assigned to one of five groups two groups receive elecoglipron at different dose levels combined with dapagliflozin two groups receive elecoglipron at different dose levels combined with a placebo matching dapagliflozin and one group receives dapagliflozin alone with a placebo matching elecoglipron. All medications are taken orally once daily. The treatment period lasts 40 weeks, during which the effects of the drugs on blood sugar and other health measures will be monitored. Throughout the study, participants will have regular assessments of their blood sugar control, body weight, and blood pressure. Researchers will measure changes in Hemoglobin A1c HbA1c, fasting plasma glucose, and self-monitored blood glucose levels. Other outcomes include weight loss and the need for rescue medication. Safety and tolerability will be closely monitored. Participation in the trial lasts for 40 weeks, during which participants will attend scheduled visits for evaluation and medication monitoring.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

This observational study focuses on adults with Type 2 Diabetes Mellitus T2DM who are evaluated to identify and describe their condition and treatment patterns. The study aims to better understand patients with T2DM, particularly those whose diabetes management is not fully controlled by lifestyle changes or stable glucose-lowering medications. AstraZeneca sponsors this study to help link patients to ongoing or future T2DM clinical trials. Participants with T2DM will undergo assessments including blood sample collection about 2 mL and evaluation of medical history, medication use, and HbA1c blood sugar levels. The study involves a single visit where these data are collected to characterize patient demographics and treatment trends. Those interested and willing to participate may be referred to other relevant T2DM studies based on these findings. During the single study visit, participants provide informed consent and undergo blood sampling and questionnaires about their health and medication use. Researchers measure HbA1c levels and document medical and surgical histories. The main outcomes include demographic information, medication usage patterns, and the potential referral of participants to future T2DM trials. The entire participation lasts only one day, focusing on capturing detailed baseline information.

Metabolic dysfunction-associated steatotic liver disease MASLD, previously called non-alcoholic fatty liver disease NAFLD, is a common chronic liver condition linked to obesity, diabetes, and dyslipidemia. This condition ranges from simple fat buildup in the liver to more severe forms like metabolic dysfunction-associated steatohepatitis MASH, which can cause liver injury, advanced fibrosis, cirrhosis, or liver cancer. Patients with MASH also face risks of cardiovascular disease and death. Currently, there is no universally approved medication for MASH, and weight loss remains the main treatment approach. This study is a randomized controlled trial comparing two treatments for adults with obesity and biopsy-confirmed MASH and liver fibrosis. Participants will be randomly assigned to receive either metabolic surgery including Roux-en-Y Gastric Bypass or Sleeve Gastrectomy or medical treatment using incretin-based therapies such as liraglutide, semaglutide, or tirzepatide. The study will follow participants for two years, after which a repeat liver biopsy will assess changes in liver fibrosis and MASH. Participants will undergo a baseline liver biopsy if none is available, followed by treatment with either surgery or medication. Throughout the two-year study, they will be monitored regularly, with assessments including liver biopsies to measure fibrosis improvement or progression, resolution of MASH, weight changes, and quality of life. Safety and treatment adherence will also be tracked to understand the impact of these interventions on liver health and overall well-being.

Researchers are investigating the safety and effectiveness of the Flexagon SFM system combined with the OTOLoc device for creating Ileo-colic and Colo-colonic anastomoses in patients undergoing colon surgery. This prospective, multi-center, single-arm clinical study focuses on patients requiring specific colon surgeries, such as Right Hemicolectomy or SigmoidLow Anterior resection, to better understand how these devices perform in surgical settings. The study involves delivering the Flexagon Self Forming Magnets SFMs and OTOLoc devices laparoscopically andor endoscopically into sections of the ileum or colon meant to be joined. OTOLoc devices help position and allow communication between two lumens until the anastomosis is fully formed by coupling SFMs. This procedure is evaluated for patients undergoing colon surgery, with the primary focus on successful anastomosis creation without needing reoperation within 30 days. Participants will be monitored for surgical outcomes, including the success of the anastomosis formation. Assessments will include medical clearance for surgery, post-surgical follow-up, and adherence to study requirements such as refraining from smoking. The trial tracks participants for at least 30 days after surgery to evaluate the primary outcome and ensure safety. Participation involves regular clinical visits and evaluations throughout the study period.

Researchers are evaluating the safety and effectiveness of the Flexagon Self Forming Magnet SFM system combined with OTOLoc for creating a gastro-jejunal anastomosis in patients undergoing gastric surgery. This prospective, multi-center, single-arm clinical study focuses on patients who require gastric surgery and aims to assess clinical outcomes using this device combination. Participants undergo gastric-jejunal anastomosis where the Flexagon SFM and OTOLoc devices are placed laparoscopically or endoscopically into targeted sections of the stomach and jejunum. The OTOLoc device is first deployed into the stomach wall to allow placement of the Flexagon SFM, which is then similarly positioned in the jejunum. These magnets are coupled to form the anastomosis, allowing fluid communication until it is fully established. During the study, participants will be monitored for the success of the anastomosis creation without needing reoperation within 30 days. The study includes clinical evaluations and medical clearances before surgery, with follow-up assessments to observe outcomes and safety. Participants must remain within a certain distance from the study center and adhere to study requirements such as refraining from smoking during follow-up, with total participation lasting through the postoperative period.

Researchers are evaluating two strategies for complete revascularization in patients with acute myocardial infarction MI specifically ST-segment elevation MI STEMI or non-ST-segment elevation MI NSTEMI who also have multivessel coronary artery disease CAD and have undergone successful treatment of the culprit lesion with Percutaneous Coronary Intervention PCI. The study aims to compare physiology-guided complete revascularization to angiography-guided complete revascularization, focusing on both efficacy and safety outcomes. Participants are randomly assigned to one of two groups. One group receives physiology-guided PCI where the function of non-culprit lesions NCLs is assessed using resting full-cycle ratio RFR or fractional flow reserve FFR, with PCI performed on lesions meeting specific thresholds. The other group undergoes angiography-guided PCI, receiving routine staged PCI on all qualifying NCLs identified before randomization. Both approaches follow local practice standards for PCI. During the study, researchers monitor participants for a minimum of two years to assess the time to first occurrence of major cardiovascular events, including cardiovascular death, new MI, or ischemia-driven revascularization, as well as safety outcomes like significant bleeding, stroke, stent thrombosis, or kidney injury related to contrast use. The trial also includes an observational imaging study using optical coherence tomography in a subset of patients. Follow-up assessments will enable evaluation of both efficacy and safety over the study period.

Researchers are evaluating the impact of two different default dialysate sodium concentrations on major cardiovascular events and death in adults receiving maintenance haemodialysis for end-stage kidney disease. This pragmatic, cluster-randomised, open-label Phase 4 study compares sodium levels of 137 mmoll and 140 mmoll in real-world dialysis settings across multiple sites globally. Dialysis sites will be randomly assigned to use either a default dialysate sodium concentration of 137 mmoll or 140 mmoll for at least 90% of dialysis sessions. Other aspects of patient care will follow standard local practices. Sites must consent to participate, and individual patients will provide waiver or opt-out consent. The study expects to enroll sites over 5 to 7 years, with each participant followed for approximately 2 to 5 years until the study endpoints are reached. Participants will receive dialysis at their assigned sites with the designated sodium concentration. Researchers will monitor the time to first occurrence of major cardiovascular events or death as the primary outcome. Secondary outcomes include other cardiovascular events and individual components of the composite outcomes. Data collection and patient monitoring will continue throughout the study period, estimated to last around five years per participant.

Chronic kidney disease CKD affects over 800 million people worldwide and is expected to become the fifth leading cause of death by 2040. This trial investigates various treatments to find the best options or combinations that slow CKD progression and reduce the risk of kidney failure and related complications. The study is a Phase III, international, multi-center, adaptive, platform trial designed to answer multiple treatment questions efficiently within a common setup. Participants receive study treatments, such as finerenone tablets 10mg or 20mg or matched placebo tablets, taken orally once daily. Each treatment period lasts 2 years, with follow-up visits scheduled at about 1 month, 3 months, 6 months, 12 months, 18 months, and 2 years after starting treatment. A final visit occurs one month after completing the 2-year treatment phase. The trial is ongoing and allows participants to join multiple treatment arms either simultaneously or at different times. During the study visits, researchers collect blood and urine tests, evaluate safety, and monitor treatment adherence. Overall health status is assessed every 5 years. The main outcome measured is the change in kidney function eGFR slope from the start of treatment to week 108. Secondary outcomes include changes in albuminuria, kidney failure events, mortality, cardiovascular events, safety, and quality of life. The trial plans long-term follow-up and safety monitoring over several years.