Oostende

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 the use of epigenome-guided treatment selection compared to the usual standard-of-care SOC treatment for adults with active Crohns Disease CD. This study aims to assess the effectiveness, safety, and cost-effectiveness of using an epigenetic biomarker assay and machine-learning software called EpiPredict to help choose between two biologic therapies, Vedolizumab VDZ and Ustekinumab UST, for treating active CD. The trial includes participants who have active disease and are either new to biologic therapy or have had limited prior biologic exposure. Participants will be randomly assigned to one of two groups one group will receive biologic treatment guided by the EpiPredict software based on epigenetic blood tests, which indicates the likelihood of response to VDZ or UST, while the other group will receive biologic therapy following usual SOC without epigenetic guidance. Both groups will receive their biologic therapy according to approved product labels, with dose adjustments allowed as needed by the treating doctor. Treatment and assessments will be carried out over 26 weeks, with different assessment schedules depending on the biologic received. After this treatment period, participants will have long-term follow-up every six months up to 24 months. During the study, participants will provide blood samples for epigenetic testing and undergo clinical and endoscopic evaluations to monitor their disease activity and response to treatment. Data will also be collected from routine medical records and online questionnaires during follow-up visits. The primary measurement is the comparison of clinical remission and endoscopic response rates at Week 26 between the two treatment selection methods. Researchers will also evaluate cost-effectiveness and explore how well the epigenetic assay predicts treatment success. Participants are required to comply with study procedures and provide informed consent to participate fully.

Researchers are evaluating oral icotrokinra as a treatment for adults and adolescents with moderately to severely active ulcerative colitis, a chronic inflammatory disease of the large intestine causing ulcers in the colon lining. The study aims to assess how well icotrokinra works, along with its safety and tolerability in this population. This is a Phase 3, randomized, double-blind, placebo-controlled trial with a parallel group design including both adults and adolescents. Adult participants will be randomly assigned to receive either icotrokinra or placebo daily by mouth during a 12-week induction phase. At Week 12, those showing clinical response will enter a maintenance phase where they will continue icotrokinra or placebo daily for 40 weeks. Adults who do not respond will also enter the maintenance phase and receive icotrokinra. Adolescents will receive open-label icotrokinra during induction and then continue on icotrokinra during maintenance regardless of response. After completing the 40-week maintenance phase, eligible participants may join a long-term extension study. Participants will be monitored regularly through clinical assessments at specified time points including Week 12 for induction and Week 40 for maintenance. Outcomes measured include rates of clinical remission, symptom improvement, endoscopic and histologic healing, and quality of life scores. Safety will be evaluated by tracking adverse and serious adverse events throughout the study. The total study duration may extend up to approximately 6 years, ending in 2032, allowing long-term evaluation of icotrokinra in ulcerative colitis management.

Researchers are evaluating eloralintide, a drug given once weekly, in adults who have persistent obesity or are overweight, including those with or without type 2 diabetes. The study focuses on people who are already on stable incretin therapy, aiming to compare the effects and safety of eloralintide to a placebo over about 80 weeks. This phase 3 trial is sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive one of four different doses of eloralintide or a placebo, all administered by subcutaneous injection. The treatment period involves weekly dosing, continuing through the study duration. The study uses a double-blind design, meaning neither participants nor researchers know who receives the drug or placebo. The main goal is to measure changes in body weight from the start to week 64, along with other health indicators. Throughout the study, participants will undergo various assessments including measurements of waist circumference, blood pressure, fasting glucose, insulin levels, and inflammatory markers. They will also complete questionnaires about their quality of life and eating behaviors. Researchers will monitor medication use and drug levels in the body to understand how eloralintide behaves. The total participation time is about 80 weeks, with safety and efficacy evaluations at regular intervals.

Researchers are evaluating icotrokinra for its effectiveness and safety in people with moderately to severely active Crohns disease, a condition causing severe inflammation in the intestines. This clinical trial is a Phase 2b3 study aiming to understand how well icotrokinra works compared to placebo to improve symptoms and intestinal healing. Participants will be randomly assigned to receive one of several treatments two different doses of icotrokinra or a matching placebo, taken orally every day during an induction period of up to 12 weeks. Based on their response at Week 12, participants may continue with maintenance dosing or placebo up to Week 40. Those completing the maintenance phase may join a long-term extension study for further evaluation. During the trial, participants will be monitored with clinical assessments, endoscopy, and patient-reported outcomes to measure response, remission, and safety. The main outcomes include clinical response and remission at Weeks 12 and 40, along with endoscopic healing. Safety will be tracked through adverse event reporting up to four weeks after the last dose. The study is expected to continue until 2032, with multiple visits for treatment and evaluations throughout.

Researchers are evaluating a new treatment approach for colon cancer, focusing on a specific type called mismatch repair proficientmicrosatellite stable MMRpMSS colon cancer. This Phase 2 study compares a combination of dostarlimab with CAPEOX chemotherapy to CAPEOX chemotherapy alone. The study aims to find early signs of how well this combination works before surgery and to understand how blood and tumor markers might predict treatment response. Participants will be randomly assigned to receive either dostarlimab plus CAPEOX chemotherapy or CAPEOX chemotherapy alone. Both treatments are given before surgery, a process known as neoadjuvant therapy. The study includes two groups one receiving the combination treatment and the other receiving only chemotherapy. Treatment duration and follow-up are planned to assess response and safety. During the study, participants will undergo various assessments including tumor tissue collection via colonoscopy, evaluations of tumor response, and monitoring for adverse events. Researchers will measure major pathological response rates and track any side effects up to approximately 105 weeks. The study also looks at the percentage of participants who can undergo tumor removal surgery, and detailed pathological response rates. Safety and effectiveness are monitored throughout the treatment and follow-up periods.

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.

Parkinsons disease PD is a neurological disorder that affects the brain and worsens over time, with symptoms such as tremors, stiffness, and slow movement. This research aims to assess how effective FoslevodopaFoscarbidopa is in treating adults with advanced Parkinsons Disease in Belgium under routine clinical practice. Approximately 120 adult participants prescribed this treatment will be studied across multiple sites. Participants will receive FoslevodopaFoscarbidopa through subcutaneous infusion as directed by their doctors according to local guidelines. This observational study does not involve additional interventions beyond routine care. Participants will continue their usual treatment while being followed for up to 18 months. During the study, participants will attend regular hospital or clinic visits as part of their standard care. Researchers will monitor changes in symptoms, focusing on OFF time periods when medication effects wear off measured by a specific Parkinsons rating scale over approximately six months. The study involves no extra procedures or burdens beyond routine practice and aims to collect data on the treatments impact over time.

Researchers are evaluating the safety and effectiveness of induction therapy using Afimkibart also called RO7790121 in people with moderately to severely active ulcerative colitis UC. This Phase III study is designed as a multicenter, double-blind, placebo-controlled trial to compare Afimkibart with a placebo. The study aims to understand how well Afimkibart works to induce remission in UC and its safety profile. Participants will be randomly assigned to one of two groups. One group will receive Afimkibart through an intravenous IV infusion followed by a subcutaneous SC injection, while the other group will receive matching placebo infusions and injections. The treatment period lasts 12 weeks, during which researchers will assess the effects of the therapies. Throughout the study, participants will undergo various assessments including evaluations of clinical remission, endoscopic improvement, histologic changes, and symptom severity at specified time points such as baseline, Week 2, and Week 12. Safety will be monitored by tracking adverse events for up to 30 weeks after starting treatment. The total participation duration spans the treatment and follow-up periods to gather comprehensive data on outcomes and safety.

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.