Ashkelon

Researchers are studying a medicine called enlicitide to reduce low-density lipoprotein cholesterol (LDL-C) in adults with high cholesterol (hyperlipidemia). This trial aims to find out if taking enlicitide together with rosuvastatin, a standard cholesterol-lowering drug, works better than a placebo in lowering LDL-C levels. The study is a Phase 3 trial that is randomized, double-blind, and placebo-controlled to ensure accurate and unbiased results. Participants will receive oral tablets of enlicitide or placebo along with oral capsules of rosuvastatin or placebo. The study compares the effect of enlicitide plus rosuvastatin against placebo to evaluate their impact on LDL-C. The treatment period lasts 8 weeks, during which participants take their assigned medications as directed. During the study, researchers will measure the average percent change in LDL-C from the start of the trial to week 8. Participants will be monitored for safety and any side effects throughout the study. The total participation time includes screening, treatment, and follow-up assessments to evaluate the medicines' effects and safety in adults aged 18 to 64 with hyperlipidemia.

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 evaluating faricimab in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) affecting at least one eye. The study, called FaReal, aims to assess the effectiveness, safety, clinical insights, and treatment patterns of faricimab in real-world routine clinical practice over a two-year follow-up period. It also seeks to describe and evaluate health economic aspects related to prior anti-VEGF treatments and current faricimab therapy. Faricimab will be given following local clinical practice and labeling guidelines. Patients must have started faricimab treatment at or within three months before signing consent and have received at least one dose in the study eye. The study does not specify fixed dosing schedules but observes real-world use over time. Participants will have data collected on visual acuity and central subfield thickness at baseline and throughout the study. The main outcome measure is the change in visual acuity from the start date to 12 months. Data on treatment safety, clinical practice insights, and health economic factors will also be gathered. The total follow-up period for patients is two years, allowing for long-term monitoring of treatment effects and safety.

Researchers are investigating the long-term safety and tolerability of open-label iptacopan in adults with primary IgA nephropathy who have previously completed specific clinical trials (CLNP023X2203 or CLNP023A2301). This extension study is designed to allow participants continued access to iptacopan until certain conditions are met, such as reaching three years from the last patient first visit, loss of treatment benefit, negative benefit-risk profile, initiation of dialysis or kidney transplant, or commercial availability of the drug. The study will also assess the drug's effects on disease progression every six months. Participants who completed the prior trials and meet inclusion criteria may receive oral iptacopan capsules at a dose of 200 mg twice daily. The study is open-label and non-randomized and will continue treatment under this regimen until one of the study-defined stopping points is reached. Supportive care with ACE inhibitors or ARBs is maintained as per clinical guidelines, and vaccination against certain infections is required before enrollment. During the study, participants will be monitored for safety, including serious adverse events, adverse events of special interest, vital sign abnormalities, ECG changes, and laboratory test abnormalities from the first day of treatment until seven days after the last dose. Efficacy assessments occur every six months to evaluate clinical effects on disease progression. The study aims to collect long-term safety and tolerability data while providing ongoing treatment access until the drug becomes commercially available or other stopping criteria apply.

Researchers are conducting a Phase 3 multicenter, randomized, double-blind, placebo-controlled trial to assess the safety and effectiveness of navenibart in preventing attacks in adults and adolescents with type 1 or type 2 hereditary angioedema (HAE). This study compares navenibart to a placebo to determine its ability to reduce the frequency of HAE attacks. Participants will receive either navenibart or a placebo as subcutaneous injections. The study treatment period lasts for 6 months, during which the number of investigator-confirmed HAE attacks will be tracked and analyzed to evaluate the treatment's impact. During the trial, participants will be closely monitored for HAE attack frequency and safety. Researchers will collect data on the number of attacks from Day 1 through Day 181 to measure treatment efficacy. Safety assessments will also be conducted throughout the study to ensure participant well-being.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are evaluating the effectiveness, antitumor activity, safety, and tolerability of selinexor combined with low-dose dexamethasone in participants with penta-refractory multiple myeloma, as well as selinexor with bortezomib and low-dose dexamethasone in participants with triple-class refractory multiple myeloma. This phase 2b, open-label, multi-arm clinical trial aims to study these treatments in patients who have shown resistance to multiple prior therapies. The trial focuses on these specific groups of refractory multiple myeloma patients to assess treatment response and safety. Participants will receive oral selinexor and dexamethasone tablets. Those in the triple-class refractory group will additionally receive subcutaneous injections of bortezomib. The study includes different arms depending on prior treatment history and refractory status. Treatment schedules and doses vary according to protocol versions and participant subgroup. This trial is designed to explore the combination therapies in a multi-arm setting to find effective options for difficult-to-treat multiple myeloma. During the study, participants will be monitored for response from the date of randomization until death, approximately over 60 months. Researchers will assess overall response rate as the primary outcome. Participants will undergo evaluations including performance status assessments and pregnancy testing as applicable. Safety monitoring includes tracking adverse effects and tolerability of the drug combinations. Contraception use and long-term follow-up are part of the study procedures to ensure participant safety and data collection over time.

Psoriatic arthritis (PsA) is a long-lasting inflammatory condition that affects the joints and skin in people with psoriasis (PsO). This research aims to evaluate how well the drug zasocitinib (TAK-279) works in adults with active PsA who have not previously used biologic disease-modifying antirheumatic drugs. The study is a Phase 3 clinical trial designed to compare zasocitinib against an active comparator and placebo in this patient group. Participants will receive treatment with either zasocitinib tablets, an active comparator capsule, or a matching placebo. The study includes multiple groups to assess the effects of these treatments. Participants will be followed and treated for up to 60 weeks during the study period. During the study, participants will undergo assessments to measure the percentage achieving improvement according to the American College of Rheumatology 20 (ACR20) response at 16 weeks. Researchers will monitor symptoms, joint and skin involvement, and overall safety throughout the trial. Participants will have regular visits for evaluations and will be observed for treatment effects and any side effects over the full course of the study.

Researchers are evaluating the safety and effectiveness of telisotuzumab vedotin compared to docetaxel in adults with previously treated non-squamous non-small cell lung cancer (NSCLC) that overexpresses c-Met. This phase 3 study focuses on participants with advanced or metastatic NSCLC who have specific genetic markers and have progressed after prior therapies. The study aims to assess changes in disease activity and adverse events over time. Participants will be randomly assigned to receive either intravenous telisotuzumab vedotin every two weeks or intravenous docetaxel every three weeks. Treatment continues until predefined discontinuation criteria are met. Those who benefit from the study treatment may have the option to continue receiving it through an extension or rollover study. Approximately 698 adults will be enrolled worldwide at about 330 sites. During the study, participants will attend regular hospital or clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure progression-free survival and overall survival for up to approximately 39 months. The study includes careful safety monitoring and evaluates the impact of treatment on disease progression and patient well-being.

This research evaluates the effects of empasiprubart compared to intravenous immunoglobulin (IVIg) in adults diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a condition affecting the nerves. The study is a Phase 3 trial aiming to assess the safety and effectiveness of these treatments. Participants must meet specific CIDP diagnostic guidelines and have shown response to IVIg in the past five years. The study is divided into two parts. In Part A, lasting 24 weeks (6 months), participants receive either empasiprubart with a placebo mimicking IVIg, or IVIg with a placebo mimicking empasiprubart. Following this, Part B lasts 96 weeks (24 months), during which all participants receive empasiprubart. Both treatments are given by intravenous infusion. Placebos are used to maintain blinding in the study. Participants will be monitored for changes in their disease symptoms, particularly focusing on improvements measured by a reduction of at least 1 point in the adjusted inflammatory neuropathy cause and treatment (aINCAT) score by week 24. Throughout the study, safety and disease activity will be regularly assessed. The total study duration for participants is up to 120 weeks, including both treatment parts.