Englewood

Researchers are investigating whether buntanetap/Posiphen can help treat early Alzheimer's disease in adults aged 55 to 85 years. This Phase 3 study aims to find out if buntanetap/Posiphen improves thinking abilities and daily functioning compared to a placebo. It also evaluates the safety of buntanetap/Posiphen by monitoring any medical issues that participants may experience during the trial. Participants will take either a 30 mg capsule of buntanetap/Posiphen or a placebo capsule by mouth once daily for 18 months. The study includes regular clinic visits at screening, enrollment, and months 1, 3, 6, 9, 12, 15, and 18. During some visits, participants will have brain MRI scans. The study uses a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo. Throughout the study, participants will complete tests and questionnaires to measure cognitive function and daily living activities, including the ADAS-Cog13 and ADCS-iADL scales. Phone calls before and after visits help track progress and adherence. Safety is closely monitored with ongoing assessments from screening through the 18-month treatment period.

Researchers are studying adults with confirmed Primary Biliary Cholangitis (PBC) and cirrhosis, a scarring of the liver caused by damage to bile ducts. PBC is a slowly progressing disease that causes bile acid buildup and further liver damage, which can lead to cirrhosis. This study aims to evaluate if elafibranor, a daily medication, can prevent worsening clinical outcomes such as the need for liver transplant or death, compared to a placebo. It also looks at the safety of long-term elafibranor use and its effect on symptoms like itching and tiredness. Participants will take either an 80 mg tablet of elafibranor or a matching placebo once daily for up to 3.5 years in a double-blind setup, meaning neither the participants nor researchers know who receives which treatment. This long-term treatment period is designed to monitor the drug's impact over time. The study includes two groups: one receiving elafibranor and the other receiving placebo, with treatment lasting up to approximately 42 months. During the study, participants will be regularly assessed from the start until 4 weeks after treatment ends, with a maximum involvement of 3.5 years. Researchers will measure event-free survival, tracking if participants avoid clinical events indicating disease worsening. Safety monitoring will include tracking side effects and overall health, while symptom impact will be evaluated. Participants will provide informed consent and follow the study protocol throughout this extended observation period.

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.

This research aims to test whether a cognitive training program can improve processing speed abilities in people who have recently experienced an acute traumatic spinal cord injury (SCI). SCI affects about 18,000 individuals annually in the US, and while physical limitations and therapies have been studied extensively, cognitive difficulties such as attention, memory, and processing speed are less understood. These cognitive issues can impact employment, social activities, daily tasks, and mental health, making recovery and rehabilitation more challenging. This study focuses on early intervention to potentially improve overall health and well-being after SCI. Participants will engage in game-like computerized activities designed as a cognitive training program or a placebo version of similar game-like activities. The study compares these two behavioral interventions to evaluate changes in cognitive processing speed shortly after injury. This pilot study is multisite and targets individuals approximately within six months post-injury. During the study, participants' cognitive abilities will be assessed using tests like the Useful Field of View (UFOV), Letter & Pattern Comparison (LPC), and Symbol Digit Modalities Test (SDMT) at baseline, immediately after treatment (week 13), and at a long-term follow-up (week 25). Researchers will monitor changes in processing speed and cognitive function over time to understand the impact of the training. The total participation involves these assessments and intervention periods to track cognitive improvements and safety.

Researchers are evaluating the clinical benefit, performance, and safety of a totally implantable cochlear implant (TICI) system in adults with sensorineural hearing loss. This condition involves damage to the inner ear or auditory nerve, leading to hearing impairment. The investigational device includes a microphone placed under the skin to capture speech and environmental sounds, allowing hearing without visible external parts. The study is pivotal and prospective, focusing on adults aged 18 years and older with bilateral sensorineural hearing loss. Participants will receive the totally implantable cochlear implant system, known as the TI1132 implant, which is designed to improve hearing function. The study is multi-center and pre-market, involving implantation surgery followed by activation of the device. The research will monitor speech recognition performance in quiet environments from before implantation through six months after activation, and will also track any adverse events or device issues up to 12 months post-activation. During the study, participants will undergo hearing tests, including word recognition assessments, and complete questionnaires to evaluate the device's impact on daily life and hearing ability. Safety and device performance will be closely monitored through scheduled follow-ups. The total duration of participant involvement includes preimplantation screening, implantation, activation, and up to one year of post-activation observation to assess both clinical outcomes and any potential complications.

Researchers are evaluating the clinical benefits of a new treatment combination for adults with metastatic uveal melanoma who have not received immune checkpoint inhibitor therapy before. This study compares the combination of RP2, a genetically modified herpes simplex virus designed to kill tumors and stimulate the immune system, with nivolumab, an anti-PD-1 antibody, against the combination of nivolumab and ipilimumab, a CTLA-4-blocking antibody. This is a randomized, open-label study conducted in phases 2 and 3 to assess the effectiveness and safety of these treatments. Participants will receive either the RP2 and nivolumab combination or the nivolumab and ipilimumab combination. RP2 is administered directly into tumors that can be injected, while nivolumab and ipilimumab are given as biological therapies to help the immune system attack the cancer. The study includes monitoring treatment effects over time and may involve multiple injections and infusions as per the study protocol. Treatments are designed to be given to patients who have measurable tumors suitable for injection. During the study, participants will be closely followed to measure overall survival and progression-free survival for up to three years after their last dose. Researchers will conduct various assessments including tumor measurements, safety monitoring, and laboratory tests to evaluate how well the treatments work and their safety. The study requires participants to provide tumor biopsy samples and meet specific health criteria to ensure their safety and the reliability of the results.

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection, in adults with type 1 diabetes. The study aims to see how well weekly insulin icodec controls blood sugar levels compared to daily insulin glargine when both are combined with insulin aspart. This phase 3 study will last about 26 weeks, or roughly 8.5 months. Participants will receive either insulin icodec or insulin glargine, both given as subcutaneous injections. All participants will also use insulin aspart as a subcutaneous injection. The study compares these two insulin regimens to assess their effects on blood sugar control over the 26-week period. During the study, researchers will monitor changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 26. Participants will follow the study protocol including self-measured plasma glucose profiles. Safety and efficacy will be evaluated throughout the treatment period to understand the impact of the insulin regimens on blood sugar control and participant health.

Researchers are evaluating efruxifermin (EFX) in adults aged 18 to 80 who have compensated cirrhosis caused by nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the safety and effectiveness of EFX in improving liver health and delaying disease progression in this population. The study focuses on subjects with advanced liver fibrosis (stage 4) but without liver decompensation. Participants are randomly assigned to receive either efruxifermin or a placebo, both administered by subcutaneous injection. The study includes two cohorts: Cohort 1 requires biopsy confirmation of liver fibrosis and specific metabolic features, while Cohort 2 allows biopsy or non-invasive diagnosis. Treatment and observation continue over an extended period to evaluate changes in liver fibrosis and clinical events. During the study, researchers will monitor the time until significant clinical events such as disease progression or liver decompensation occur, with a follow-up of up to five years. For Cohort 1, the proportion of participants showing improvement in fibrosis without worsening steatohepatitis will be assessed at 96 weeks. Participants will undergo regular evaluations including clinical assessments and laboratory tests to track liver function and safety throughout the 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.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.