Mechelen

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

Researchers are evaluating the safety and tolerability of AMG 691 in both healthy adults and adults with mild-to-moderate asthma. This Phase 1 study aims to assess how participants respond to single and multiple doses of AMG 691 compared to a placebo. The study includes adults aged 18 to 70 years and focuses on understanding the drug's effects in these populations. Participants receive either AMG 691 or a placebo through subcutaneous injections. The study includes single ascending dose and multiple ascending dose periods to carefully monitor reactions to different dosing levels. Healthy participants receive single or multiple doses, while participants with asthma receive multiple doses. Female participants must be of non-childbearing potential or use effective contraception if of childbearing potential. During the study, participants undergo medical evaluations, lung function tests, blood tests, and monitoring for any treatment-emergent adverse events over approximately 11 months. Researchers track lung function measures such as forced expiratory volume and biomarkers like blood eosinophils and exhaled nitric oxide. Safety and tolerability are closely monitored through regular assessments and questionnaires to evaluate asthma control and overall health.

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are conducting a Phase 3 study to compare two front-line treatments for adults with nonsquamous non-small cell lung cancer (NSCLC) that is stage IV or advanced stage IIIB/C. The study focuses on patients whose tumors have a KRAS p.G12C mutation and are negative for PD-L1 expression. The main goal is to evaluate how each treatment affects progression-free survival and overall survival over about 2.5 years. Participants will be randomly assigned to receive either sotorasib combined with platinum doublet chemotherapy or pembrolizumab combined with platinum doublet chemotherapy. Sotorasib is given orally, while pembrolizumab is given intravenously. Both groups will receive the combination therapies as their initial treatment for advanced NSCLC. During the study, participants will be monitored regularly to assess treatment effects and safety. Researchers will track how long patients live without the cancer worsening and overall survival over approximately 2.5 years. The study includes evaluations to determine eligibility and ongoing assessments to monitor health and treatment response throughout the trial period.

Researchers are evaluating the safety and effectiveness of the Supera Vascular Mimetic Implant, a special stent designed to treat narrowed or blocked areas in the common femoral artery, compared to traditional surgical removal of artery plaque (endarterectomy). This study focuses on patients with Peripheral Arterial Disease classified as Rutherford category 2, 3, or 4. The goal is to see if the implant is at least as effective as surgery and possibly safer for patients. Participants are randomly assigned to one of two groups: one receiving the Supera stent through a minimally invasive procedure involving balloon dilation and stent placement, and the other undergoing standard surgical endarterectomy. The procedure involves crossing the lesion with a guidewire, angiographic assessment, and optional post-dilation for the stent group. The surgery group receives treatment according to standard care. Follow-up visits are scheduled at 1, 6, 12, 24, and 36 months after the procedure. Throughout the study, patients will undergo assessments including physical exams, walking ability questionnaires, blood tests, ankle and toe blood pressure measurements, and ultrasound imaging to check blood flow. Researchers will monitor for outcomes such as artery openness (patency), need for additional treatments, wound healing, and any adverse events up to 36 months. Primary outcomes focus on artery openness at 12 months and safety within 30 days post-procedure.

Researchers are evaluating the effectiveness and safety of brenipatide compared to a placebo in adults with Alcohol Use Disorder (AUD) and hazardous alcohol use. This Phase 3, multicenter, randomized, double-blind study aims to understand if brenipatide can help participants reduce or stop drinking. The study lasts approximately 56 weeks and focuses on changes in drinking patterns using the Timeline Followback Method (TLFB). Participants will receive either brenipatide (LY3537031) or a placebo, both administered by subcutaneous injection. Participants who cannot self-inject will have assistance from a trained support person. They are expected to store and use the blinded study drug as directed, maintain electronic and paper diaries, and complete questionnaires throughout the study. During the study, participants will have scheduled visits to monitor their progress, including assessments of drinking behavior and safety evaluations. Researchers will measure changes in alcohol use patterns up to 56 weeks. Participants must be motivated to reduce or stop drinking and be available for all study visits and procedures. Safety and adherence will be closely monitored throughout the trial.

Researchers are evaluating the safety and effectiveness of brenipatide compared to a placebo for adults with moderate-to-severe Alcohol Use Disorder (AUD). This phase 3 study aims to better understand if brenipatide can help reduce drinking in this population. Participants will be followed for about 56 weeks to gather comprehensive information. Participants will receive either brenipatide (LY3537031) or a placebo, both given by subcutaneous injection. The study involves a randomized, double-blind design, meaning neither the participants nor the researchers know who receives which treatment during the trial. This method helps provide reliable results about the effects and safety of brenipatide. During the study, participants will attend scheduled visits, self-inject the study drug, and complete electronic and paper diaries as well as questionnaires. Researchers will monitor changes in drinking patterns using the Timeline Followback Method for up to 56 weeks. Safety monitoring and regular assessments will be performed throughout the study to track participants' health and adherence.

Researchers are investigating the safety and effectiveness of eloralintide compared to a placebo in adults with persistent obesity or overweight. This includes people with or without type 2 diabetes who are already on stable weekly incretin therapy. The study is a phase 3, randomized, double-blind trial focusing on this specific group to better understand treatment outcomes. Participants will receive either eloralintide or a placebo, both given by subcutaneous injection once a week. The study compares these two treatments over the course of the trial. Participants must continue their stable incretin therapy throughout the study period. The study lasts about 80 weeks in total. Researchers will monitor changes in body weight from the start of treatment to week 64 as the main outcome. Participants will have regular assessments to track their health, safety, and treatment effects during this time.

Researchers are evaluating the effectiveness of adding LY3537982 (olomorasib) to standard anti-cancer drugs compared to standard treatment alone in participants with untreated advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C gene mutation. This pivotal Phase 3 trial includes participants with locally advanced or metastatic NSCLC and considers their programmed death-ligand 1 (PD-L1) expression levels. The study includes multiple parts: Dose Optimization, Part A, and Part B are randomized, while Safety Lead-In for Part B and Part C are non-randomized. Treatments being assessed include LY3537982 taken orally, pembrolizumab administered intravenously, and standard chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed given intravenously. Participants receive these treatments according to their assigned groups based on their PD-L1 expression and tumor histology. Participants will be monitored with regular assessments including measuring disease progression, safety evaluations, and treatment emergent adverse events for up to approximately one year, with overall study participation potentially lasting up to three years depending on individual response and health status. Outcome measures focus on progression-free survival and safety, capturing any adverse events from the start of treatment until disease progression or death.