San Donato Milanese

Researchers are evaluating the effects of enicepatide, a dual GLP-1GIP receptor agonist, at multiple doses compared with placebo for weight management in adults with obesity or overweight who do not have Type 2 diabetes. This Phase III, randomized, double-blind study aims to assess both the efficacy and safety of once-weekly enicepatide in this population, addressing weight-related comorbidities such as prediabetes, hypertension, and cardiovascular conditions. Participants will be randomly assigned to receive either placebo or one of three enicepatide dosing regimens, administered once weekly via an integrated drug-device combination product. The treatment phase lasts through 72 weeks, during which changes in body weight and other health measures are monitored. The study includes multiple assessments to track body weight percentage change, waist circumference, fasting glucose and insulin levels, lipid profiles, blood pressure, and quality of life measures. Throughout the study, participants will undergo regular evaluations including physical examinations, laboratory tests, and questionnaires related to physical functioning and urinary incontinence. Researchers will monitor adverse events, patient-reported health questionnaires, and biomarkers at baseline and weekly intervals through week 72. This long-term follow-up allows for a comprehensive assessment of treatment effects and safety in participants managing obesity or overweight without Type 2 diabetes.

Researchers are evaluating a predictive tool called the Multifactorial Dynamic Perfusion Index MDPI to estimate the risk of acute kidney injury after cardiac surgery involving cardiopulmonary bypass CPB. This observational study involves adults and infants undergoing cardiac surgery, aiming to validate the MDPI in adults, develop a version for infants under 20 kg, and explore if the MDPI can predict other complications including mortality. The MDPI combines seven variables measured during CPB, many of which can be modified by the surgical team to potentially improve patient outcomes. The study is divided into three parts first, validating the MDPI in 800 adult cardiac surgery patients from two centers using existing CPB monitors that collect data such as hematocrit, oxygen delivery, arterial pressure, and transfusions second, developing a modified MDPI for 200 infants under 20 kg undergoing congenital heart surgery with additional infant-specific variables and third, investigating whether the MDPI can predict other postoperative issues like low cardiac output, longer ICU stays, bleeding complications, and 30-day mortality. Data collection includes parameters recorded during surgery and postoperative creatinine values. Participants will undergo cardiac surgery with CPB, during which relevant physiological data will be continuously recorded by specialized monitors. After surgery, kidney function and other outcomes will be monitored for up to 48 hours, with extended follow-up for complications and mortality over 30 days. Researchers will analyze how well the MDPI predicts acute kidney injury and other clinical outcomes, aiming to incorporate the MDPI into real-time monitoring devices to guide therapeutic decisions during surgery.

Researchers are evaluating the safety and effectiveness of three different dose regimens of MORF-057, a small molecule drug, in adults with moderately to severely active Crohns disease CD. This Phase 2, randomized, double-blind, placebo-controlled, multicenter study aims to compare these doses with a matching placebo during an induction treatment period. The study includes adult participants who have active symptoms of CD and have not adequately responded to other treatments. Participants will first undergo a 14-week induction period where they receive either one of the three blinded MORF-057 dose regimens or a matching placebo, all taken orally. Following this, all participants enter a 38-week maintenance period receiving open-label MORF-057. Those who complete this 52-week treatment phase may have the chance to continue treatment for an additional 52 weeks during a long-term extension. MORF-057 is designed to selectively inhibit integrin 47. During the study, participants will have their disease activity monitored using endoscopic assessments and clinical symptom scores, such as the Simple Endoscopic Score for Crohns Disease SES-CD and the Crohns Disease Activity Index CDAI. Researchers will assess the proportion of participants showing endoscopic response and clinical remission at Week 14. Safety and adherence will be closely followed throughout the treatment and extension phases. The entire study spans up to 6 years, allowing for long-term evaluation.

Researchers are evaluating the safety and effectiveness of NNC0487-0111 in people who have excess body weight and knee osteoarthritis. This study compares two doses of NNC0487-0111 given as weekly injections under the skin against a placebo, with the goal of helping participants lose weight and reduce knee pain. Participants have knee osteoarthritis confirmed by clinical and radiographic criteria and will follow a reduced-calorie diet and increased physical activity throughout the study. Participants will be randomly assigned to receive one of three treatments NNC0487-0111 dose level 1, NNC0487-0111 dose level 2, or a placebo, all given once weekly by subcutaneous injection using a pre-filled pen injector. The injections will be administered to the thigh, abdomen, or upper arm. All participants will be encouraged to follow a reduced-calorie diet and increase physical activity during the trial. The treatment period lasts for 80 weeks. Throughout the study, participants will have regular assessments of body weight, knee pain, physical function, and other health measures. Researchers will collect data on changes in weight, knee pain scores using the WOMAC index, physical function, blood pressure, cholesterol levels, blood sugar markers, and use of pain medication. Safety will be monitored through reporting of adverse events. The study is expected to continue until August 2028, with visits and evaluations occurring at scheduled intervals during the treatment period.

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.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can reduce plaque buildup in the hearts blood vessels in people who have had a heart attack. The study focuses on patients with acute myocardial infarction and compares the effects of ziltivekimab against a placebo. This phase 3 trial aims to understand the impact of ziltivekimab on heart vessel plaque over about 15 months. Participants will be randomly assigned to receive either ziltivekimab or a placebo, both given as monthly injections under the skin for 12 months alongside standard heart care. The study uses advanced imaging techniques like intravascular ultrasound, near-infrared spectroscopy, and optical coherence tomography to monitor changes in the arteries. The treatment is administered shortly after participants undergo certain heart procedures. During the study, participants will undergo detailed heart imaging and blood tests at the start, at 4 weeks, and at 52 weeks to measure changes in plaque volume and inflammation markers. Researchers will monitor heart-related events like heart attacks, strokes, and deaths throughout the year. The study includes adherence tracking and safety monitoring to evaluate the treatments effects and any risks over the full duration.

Researchers are evaluating the safety and effectiveness of the drugs eltrekibart and mirikizumab in adults with moderately to severely active ulcerative colitis UC, a chronic inflammatory bowel disease. This Phase 2 study aims to find out how these treatments work alone or in combination to improve UC symptoms and health. The study is sponsored by Eli Lilly and Company and will last about 4 to 5 years, including screening. Participants will be randomly assigned to receive one of several treatments eltrekibart with a placebo, mirikizumab with a placebo, both drugs together, or placebo alone. The study is double-blinded, meaning neither the participants nor the researchers know which treatment is given to ensure unbiased results. The treatment period includes dosing with the study drugs or placebo, and participants will be monitored for safety and response. Participants will be involved in the trial for around 69 weeks, including a screening period of up to 35 days before starting treatment. Throughout the study, they will undergo assessments to measure clinical remission, response, endoscopic improvement, and quality of life using questionnaires. Blood samples will be taken to study drug levels, and researchers will monitor safety and disease activity regularly. The main outcome is the percentage of participants achieving clinical remission at Week 12, with additional measures assessed up to Week 52.

Researchers are evaluating the safety and effectiveness of several long-acting antibody treatments for adults with moderately to severely active ulcerative colitis UC. This Phase 2, multicenter platform study aims to compare multiple investigational therapies, including both single agents and combinations, to better understand their potential benefits and risks. The study is sponsored by Spyre Therapeutics, Inc. and involves adults aged 18 to 75 years with active UC confirmed by endoscopy and histology.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Researchers are evaluating the use of the pulsed field ablation system, which includes the VARIPULSE Catheter, TRUPULSE Generator, and the new VARIPULSE Pro software, for treating participants with paroxysmal atrial fibrillation PAF and persistent atrial fibrillation PsAF. The study focuses on the workflow effectiveness of this system during cardiac ablation procedures aimed at managing irregular heartbeats in these populations. Participants will undergo pulsed field ablation PFA using the VARIPULSE Catheter and TRUPULSE Generator with the VARIPULSE Pro software. The study involves a single group receiving this device-based intervention to treat symptomatic PsAF or PAF through pulmonary vein isolation PVI alone or combined with cavotricuspid isthmus-dependent atrial flutter ablation. The treatment is delivered during an ablation procedure with the device system. During the study, participants will be monitored for various outcomes including acute effectiveness during the procedure, durability of pulmonary vein isolation at 3 months, and procedural details such as pulsed field application time and number of applications. Safety assessments include monitoring for serious and non-serious adverse events up to 3 months post-procedure, neurological evaluations using MRI and cognitive scales, and assessment of pulmonary vein stenosis. The total participation duration extends at least 3 months post ablation for follow-up and outcome measurement.