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Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are investigating the safety and effectiveness of efruxifermin in people with non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis (stage 2 or 3). This Phase 3 study is randomized, double-blind, and placebo-controlled, enrolling a total of 1650 participants in two groups to evaluate treatment outcomes. Participants will receive either efruxifermin or a placebo by subcutaneous injection. The study involves two cohorts, with Cohort 1 including patients who have biopsy-confirmed NASH or MASH and specific liver fibrosis and activity scores. The treatment period and detailed dosing schedules are not provided but the study compares the effects of the active drug against placebo. During the study, participants will be monitored for improvement in liver disease status, including resolution of NASH/MASH and at least a one-stage improvement in liver fibrosis after 52 weeks for Cohort 1. Long-term outcomes such as event-free survival will be observed over 240 weeks. Safety and efficacy assessments will be conducted throughout the study period, including evaluations of liver histology and metabolic health.

This research aims to assess the effectiveness, safety, and patient-reported outcomes of a port delivery system (PDS) with ranibizumab 100 mg/mL refilled every 36 weeks in people with neovascular age-related macular degeneration (nAMD). The study is a Phase IIIb, multicenter, single-arm trial involving participants who have been diagnosed with nAMD within the past 24 months and previously treated with anti-vascular endothelial growth factor (VEGF) injections. The goal is to understand how well this refill regimen works and how safe it is for patients living with this eye condition. Participants will receive ranibizumab through a PDS implant that is refilled every 36 weeks. The treatment includes the implant delivering ranibizumab continuously, plus supplemental ranibizumab injections of 0.5 mg into the eye as needed. The study follows a schedule where the implant is exchanged or refilled at 36-week intervals to maintain treatment. The device is designed to provide a steady release of medication directly to the eye over time. During the study, participants will have their vision tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters, focusing on changes in their best corrected visual acuity (BCVA) at baseline and weeks 68 and 72. Researchers will monitor safety, effectiveness, and patient experiences throughout the trial. The total observation period includes assessments at these time points to evaluate how vision changes with the PDS treatment and to track any side effects or safety concerns.

Researchers are investigating the effectiveness, feasibility, and safety of combining bicycle exercise with an intensive lifestyle intervention for three months in adults recently diagnosed with untreated type 2 diabetes. This study aims to promote lifestyle changes early after diagnosis to control blood sugar levels without the use of medication. The trial focuses on patients who often show symptoms like excessive urination and thirst at diagnosis, providing a unique chance to demonstrate the benefits of exercise and diet changes. Participants will be randomly assigned to either standard care or an intensified lifestyle intervention that begins with a 30-minute bicycle exercise at 60% of their maximum heart rate, followed by a physical activity program. This program includes 3 to 5 aerobic sessions lasting 15-40 minutes each and 2 resistance training sessions weekly. Motivational coaching by phone and nutritional counseling are also part of the lifestyle intervention. Patients will be monitored and receive follow-up visits at multiple intervals over a year. Throughout the study, patients will have their blood glucose levels, heart rate, blood pressure, and other clinical parameters regularly assessed. They will be trained to measure blood glucose at home and send results for monitoring. Physical activity will be tracked using mobile phones and activity trackers. Outcome measures include achieving metabolic control at three months without anti-diabetic medication, defined by specific HbA1c targets based on initial levels. Safety and adherence will be closely observed during follow-up visits at 2, 7, 30, 60, 90 days, 6 months, and 1 year.

Researchers are evaluating canakinumab, an IL-1 receptor antagonist, for treating postprandial hypoglycemia in patients who have undergone bariatric surgery. This condition causes low blood sugar after meals and currently has no approved drug treatments. The trial aims to see if canakinumab improves mental and physical health-related quality of life and reduces hypoglycemic episodes compared to placebo in this group. Participants will be randomly assigned to receive either a single subcutaneous injection of 150 mg canakinumab or a placebo injection. The treatment period lasts 28 days. Before treatment, there is a 10-day screening phase using a blinded continuous glucose monitoring system to confirm hypoglycemia. During treatment, participants will have two additional study visits for sensor changes, diary documentation, and adverse event monitoring. After treatment, a follow-up visit occurs two months later. Throughout the study, participants will be assessed for changes in health-related quality of life both mentally and physically at baseline, day 29, and day 90. Hypoglycemic events are tracked from baseline to day 29. Monitoring includes continuous glucose monitoring and recording adverse events. The total study duration for each person is up to four months, including screening, treatment, and follow-up visits.

This research investigates the best approach for treating low-risk patients with isolated subsegmental pulmonary embolism (SSPE), a condition where small blood clots block tiny arteries in the lungs. The study aims to clarify whether SSPE truly requires anticoagulant treatment or if careful monitoring without medication is a safe option. Currently, many patients receive anticoagulants, which can increase bleeding risk, but some evidence suggests that avoiding these drugs might be safe in selected patients without other complications. Participants are randomly assigned to receive either the anticoagulant drug rivaroxaban or a placebo, allowing comparison between clinical surveillance without anticoagulation and standard anticoagulation treatment. This phase 4, multicenter trial evaluates outcomes over a 90-day period following randomization. During the study, researchers monitor participants for recurrent venous thromboembolism and assess safety outcomes related to bleeding. Participants provide informed consent and are followed closely to observe any clots returning or adverse events. The total follow-up is at least 90 days to determine the efficacy and safety of withholding anticoagulation in this specific patient group.

Atrial fibrillation is the most common heart rhythm disorder globally, increasing 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 can restore normal heart rhythm in atrial fibrillation patients, but around 60% experience a short-term return of the condition, showing current treatments are not fully effective. Inflammation is thought to play a key role in starting and maintaining atrial fibrillation, so this study aims to explore if targeting inflammation can reduce its recurrence after electrocardioversion. This clinical trial tests whether taking low-dose Colchicine, an anti-inflammatory drug, once daily for 90 days can lower the chance of atrial fibrillation returning following electrocardioversion. Participants receive either Colchicine 0.5 mg orally or a matching placebo, both given in the same manner. The study is a Phase 3 trial called COLECTRO-AF, comparing these two groups to evaluate the effect of Colchicine treatment on post-procedure outcomes. Participants will be monitored for up to six months after electrocardioversion to see if atrial fibrillation comes back. The main outcome measured is the number of recurrences within this period. Patients undergo ECGs and other assessments to confirm heart rhythm status and monitor safety. The study requires informed consent and careful follow-up to track treatment effects and any side effects. The overall goal is to find better ways to prevent atrial fibrillation from returning after treatment.

Researchers are evaluating the potential of dapansutrile, an oral NLRP3 inhibitor, as a new treatment option for managing type 2 diabetes and its related complications. This phase 2 trial focuses on dapansutrile's ability to act as an anti-inflammatory agent that may help address both micro- and macro-vascular risks associated with diabetes. The study is based on dapansutrile's promising clinical and preclinical safety data and its unique role in treating chronic low-grade inflammatory conditions like type 2 diabetes. Participants in the study are randomly assigned to receive either dapansutrile or a placebo in a double-blind setup. The treatment period lasts for approximately 3 to 4 months, during which patients take the investigational product orally. This trial is conducted across multiple centers to assess the safety and effectiveness of dapansutrile compared to placebo. During the study, participants undergo assessments at baseline and week 26, including measuring changes in blood HbA1c levels to evaluate diabetes control. Other evaluations include monitoring inflammatory markers such as high-sensitivity C-reactive protein and overall health status to ensure safety throughout the trial. The study also tracks participant adherence and looks for any cardiovascular, renal, or hepatic concerns to ensure safe participation and completion of study procedures.

Researchers are evaluating the addition of tirzepatide, a combined GIP/GLP-1 receptor agonist, to automated insulin delivery (AID) therapy in adults with type 1 diabetes (T1D). The study aims to test if this new treatment can improve blood glucose control, as only about 30% of adults with T1D currently meet recommended glucose targets. This prospective, randomized, open-label Phase 3 study hopes to provide important data on the efficacy and safety of tirzepatide as an add-on to insulin therapy in this population. Participants aged 18 to 65 with T1D diagnosed for at least 12 months, currently using AID therapy, and meeting certain glycemic and BMI criteria will be enrolled. They will be randomly assigned to receive either tirzepatide starting at 2.5 mg weekly for four weeks followed by 5 mg weekly for 12 weeks, or continue their standard care without tirzepatide. The study treatment period includes a titration phase and a total of 16 weeks of intervention. During the study, participants will wear a continuous glucose monitor (Dexcom G7) and share device data to track glucose levels. Researchers will assess the percentage of time glucose stays within the target range (3.9 to 10.0 mmol/L) after 12 weeks of treatment. Secondary measures include time spent above or below specific glucose thresholds and changes in body mass index (BMI). Safety and adherence will be monitored throughout the study.

Researchers are evaluating whether core muscle exercises immediately after abdominal surgery affect the chance of developing incisional hernias, a common complication. The study also looks at how these exercises impact chronic postsurgical pain (CPSP) and muscle loss (sarcopenia). Although current practice limits physical activity after surgery to prevent hernias, there is no clear evidence supporting this approach, and reduced activity may lead to other problems like pain and muscle weakness. Participants are divided into two groups: one receiving standard care with physical restrictions, and the other performing four specific core muscle exercises targeting the abdominal muscles daily from the first day after surgery until two months post-surgery. The study includes patients undergoing elective or emergency abdominal surgery through laparoscopic or open methods, with midline or transverse incisions. During follow-up visits at two, twelve, and twenty-four months after surgery, doctors will perform clinical exams and ultrasounds to check for incisional hernias. They will also assess chronic postsurgical pain and its treatment and evaluate muscle mass using CT scans. The main outcome measured is the incidence of incisional hernia 24 months after surgery.