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Researchers are evaluating whether retatrutide and tirzepatide can prevent major adverse liver outcomes in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized controlled trial aims to assess these treatments compared to placebo in about 4,500 adults over approximately 224 weeks. The study is sponsored by Eli Lilly and Company and focuses on liver disease progression and related health measures. Participants will be randomly assigned to receive retatrutide, tirzepatide, or placebo, all administered by subcutaneous injection. The trial includes two placebo groups corresponding to each experimental drug. After completing the main study, eligible participants may join a 2-year extension where all will receive either retatrutide or tirzepatide regardless of their initial assignment. During the study, participants may attend around 25 to 30 clinic visits for health monitoring, study procedures, and assessments of liver function and disease status. Researchers will measure the time to major adverse liver outcomes, changes in liver fibrosis scores, liver stiffness, liver fat content, liver enzyme levels, body weight, and cardiovascular events. Monitoring will continue from baseline through study completion, with detailed evaluations at multiple timepoints including week 104.

Researchers are evaluating efruxifermin EFX in adults with non-cirrhotic nonalcoholic steatohepatitis NASH or metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage 2 or 3. This Phase 3, multi-center, randomized, double-blind, placebo-controlled study aims to assess the safety and efficacy of EFX compared with placebo. The trial includes about 1,650 participants divided into two cohorts based on liver biopsy characteristics and fibrosis stage. Participants will be randomly assigned to one of three groups EFX 28 mg, EFX 50 mg, or placebo, each given as a weekly subcutaneous injection. Cohort 1 will be evaluated over 52 weeks for histologic efficacy endpoints, while Cohort 2 will have assessments over 96 weeks. After these periods, participants may continue long-term treatment and clinical follow-up for up to approximately 240 weeks total. A follow-up visit will occur about 30 days after the last dose. During the study, participants will undergo liver biopsies, blood tests, and non-invasive assessments such as FibroScan and Enhanced Liver Fibrosis ELF score to monitor liver health and fibrosis. Researchers will track liver-related clinical outcomes, including liver events and survival, as well as safety and tolerability of the treatment. Participants who stop the study drug may still continue with scheduled assessments to support long-term safety and efficacy evaluations.

Researchers are evaluating a port delivery system PDS with ranibizumab for adults aged 50 and older who have neovascular age-related macular degeneration nAMD. This Phase IIIb study aims to assess the effectiveness, safety, and patient-reported outcomes of refilling the PDS implant every 36 weeks. The study focuses on maintaining vision and reducing the treatment burden for people with nAMD who have already received prior anti-VEGF injections. Participants will have a PDS implant surgically inserted in their study eye on Day 1, pre-filled with ranibizumab at a concentration of 100 mgmL. Those who show disease activity or receive supplemental ranibizumab injections before Week 24 will have refill exchanges every 24 weeks, while others will receive refill exchanges every 36 weeks. Supplemental intravitreal ranibizumab injections may be given as needed during the study. Throughout the trial, participants will undergo assessments including vision tests using the Early Treatment Diabetic Retinopathy Study chart, eye imaging, and monitoring of eye thickness. Researchers will track changes in vision, need for supplemental treatments, implant safety, and patient preferences. The study lasts until Week 72, with safety and adverse event monitoring continuing for approximately 19 months after implantation.

Researchers are evaluating the effectiveness, feasibility, and safety of a bicycle exercise followed by an intensive lifestyle intervention over three months in patients recently diagnosed with and not yet treated for type 2 diabetes. The study focuses on early lifestyle changes as a first-line treatment to control metabolic problems without medication. This approach seeks to show the benefits of exercise and diet changes, especially in patients with symptoms like increased urination and thirst, who often receive immediate drug treatment instead. Participants are randomly assigned to either standard care or an intervention group that performs a 30-minute bicycle exercise at 60% of their maximum heart rate, followed by a lifestyle program including 3 to 5 aerobic sessions and 2 resistance trainings per week, plus weekly motivational coaching calls. The study involves a symbolic removal of the emergency room bed to encourage exercise immediately after diagnosis. Follow-up visits occur at 2, 7, 30, 60, and 90 days, as well as at 6 months and one year. During the study, participants will monitor blood glucose at home, sending fasting glucose readings to the research team for ongoing metabolic monitoring. Clinical measurements like heart rate, blood pressure, blood gases, and HbA1c will be taken at multiple time points. Activity levels will be tracked by mobile phone and an activity tracker. The main outcome is metabolic control without medication after 3 months, with additional evaluations of physical activity, safety, and quality of life over time.

Researchers are evaluating the effects of canakinumab compared to placebo in patients experiencing postprandial hypoglycemia after bariatric surgery. This condition can significantly reduce quality of life and currently has no approved drug treatments. The trial aims to determine if canakinumab can improve mental and physical health-related quality of life and reduce hypoglycemic episodes. Participants will receive either a single subcutaneous injection of 150 mg canakinumab or a placebo injection of saline solution. The study includes a 10-day screening phase using a blinded continuous glucose monitoring system to confirm hypoglycemia, followed by a 28-day treatment period with three study visits for monitoring and data collection. After treatment, participants will have a follow-up visit two months later to assess longer-term effects. During the study, participants will wear glucose monitors, keep diaries, and report any adverse events. Researchers will measure changes in quality of life, frequency of hypoglycemic events, hypoglycemia symptoms, fear of hypoglycemia, glucose patterns, body weight, and safety outcomes. The total participation time is up to four months, including screening, treatment, and follow-up assessments.

Researchers are investigating the best approach to treat low-risk patients with isolated subsegmental pulmonary embolism SSPE, a type of blood clot in small lung arteries. The study aims to determine whether monitoring patients without anticoagulation is as safe and effective as giving anticoagulant medication. This is important because many patients currently receive anticoagulants that carry a risk of bleeding, but it is unclear if all patients with isolated SSPE need this treatment. Patients in the trial are randomly assigned to one of two groups. One group receives the anticoagulant drug rivaroxaban, starting with 15 mg twice daily for 21 days, then 20 mg once daily for a total of 90 days. The other group receives a placebo matching the same schedule. The trial compares clinical surveillance without anticoagulation to anticoagulation treatment to assess safety and effectiveness. Participants will be followed for 90 days after randomization to monitor for recurrent venous thromboembolism, significant bleeding events, and overall survival. Researchers will track these outcomes through clinical assessments and safety monitoring. This study is designed to evaluate if careful monitoring alone is a safe alternative to anticoagulation in selected patients with isolated SSPE, potentially reducing bleeding risks from treatment.

Atrial fibrillation is the most common heart rhythm problem worldwide and increases the risk of heart failure, stroke, and death. Researchers expect its prevalence to rise, especially in people over 65 years old, with about one in three developing atrial fibrillation. Electrocardioversion is a procedure that restores normal heart rhythm but often results in the arrhythmia returning within a short time. This trial aims to study whether inflammation plays a role in this recurrence and if treating it can reduce the return of atrial fibrillation after electrocardioversion. The trial compares two groups one receives a daily oral dose of 0.5 mg Colchicine for three months, taken in the morning without a loading dose, alongside their usual treatments. The other group receives a matched placebo. This is a randomized, triple-blind Phase 3 study evaluating the effect of low-dose Colchicine on preventing atrial fibrillation recurrence after electrocardioversion. Participants will be monitored for recurrence of atrial fibrillation over six months following electrocardioversion. Researchers will assess the number of arrhythmia recurrences at one, three, and six months, the time to any repeat electrocardioversion, use of antiarrhythmic drugs, and hospitalizations. Safety and overall wellbeing will also be followed during this period, with the main outcome focused on arrhythmia recurrence within six months.

Researchers are evaluating dapansutrile, an oral NLRP3 inhibitor, as a potential new treatment option for managing type 2 diabetes and its related complications. This study focuses on whether dapansutrile, which has shown promising preclinical and safety results, can reduce inflammation and address risks for cardiovascular disease associated with diabetes. The trial is a phase 2, randomized, double-blind, placebo-controlled study over 26 weeks. Participants will be randomly assigned to receive either 1000 mg of dapansutrile twice daily or a matching placebo for 26 weeks. All tablets are self-administered orally with or without food. The study compares the effects of dapansutrile against placebo on blood sugar control and inflammation over the treatment period. Throughout the trial, participants will undergo regular blood tests to measure HbA1c and fasting plasma glucose levels at baseline and multiple time points up to week 26. Researchers will also assess markers of inflammation and monitor safety. The primary outcome is the change in HbA1c from baseline to week 26. Participants are expected to complete all study procedures over approximately six months, with ongoing safety and efficacy evaluations.

Researchers are investigating whether adding a new medicine called tirzepatide, a glucose-dependent insulinotropic polypeptide GIPglucagon-like peptide-1 receptor agonist GLP-1RA, to usual insulin therapy can improve blood sugar control in adults with type 1 diabetes T1D. The study is designed as a prospective, randomized clinical trial to evaluate this combinations effect on glucose management, aiming to provide new options beyond standard insulin treatment. About 30% of adults with T1D currently meet recommended blood sugar targets, highlighting the need for improved therapies. The study will enroll adults aged 18 to 65 years with T1D diagnosed for at least 12 months who are already using automated insulin delivery AID systems. Participants will be randomly assigned to either continue their standard care or to add once-weekly injections of tirzepatide, starting at a low dose of 2.5 mg and increasing to 5 mg weekly for 12 weeks. The trial includes a 4-week dose titration phase followed by 12 weeks of treatment, comparing glucose control outcomes between groups. Participants will wear a continuous glucose monitor CGM and share their glucose and insulin data throughout the 16-week study. Researchers will assess time spent within target glucose ranges, changes in blood sugar levels, insulin doses, and body weight. Safety and adherence will be monitored during the trial. The study aims to gather important data on whether tirzepatide can help improve glucose control and quality of life for adults living with T1D.

Researchers are evaluating the impact of core muscle training on the occurrence of incisional hernia, chronic postsurgical pain CPSP, and sarcopenia after abdominal surgery. The study addresses the common practice of limiting core muscle activity post-surgery to prevent hernias, despite no evidence supporting this approach. The trial will explore whether physical restriction or specific core muscle exercises before and after surgery influence the incidence of incisional hernias and the development of CPSP and sarcopenia. Participants will be randomly assigned to one of two groups. The control group will receive standard physiotherapy, which includes early mobilization and exercises to prevent complications, while limiting core muscle activity and weight bearing based on pain. The intervention group will perform four specific core muscle exercises daily during hospitalization under physiotherapist supervision and continue at home for two months, alongside standard physiotherapy. Follow-up visits will occur at two, twelve, and twenty-four months post-surgery. During the study, participants will undergo clinical examinations and ultrasound scans to detect incisional hernias, assessments of chronic postsurgical pain and its treatment, and evaluations of muscle mass using CT scans. Researchers will also monitor exercise activity, hospital stay length, readmission and re-operation rates, and the incidence of sarcopenia. The study period includes regular follow-ups for up to two years to track these outcomes and evaluate the effects of postoperative rehabilitation.