Daytona Beach

Researchers are exploring new treatments for heart failure with preserved ejection fraction (HFpEF), a condition where the heart becomes stiff and does not relax properly. This clinical trial focuses on a study drug called MK-2828, designed to treat HFpEF. The main goal is to determine how MK-2828 affects the way two other drugs, rosuvastatin and furosemide, behave in the body. Participants will receive multiple doses of MK-2828 alongside either rosuvastatin or furosemide, both given by mouth. The study is divided into two parts: the first part evaluates the interaction between MK-2828 and rosuvastatin, while the second part assesses MK-2828 with furosemide. All treatments involve oral administration of the drugs. During the study, participants will be monitored for how their bodies process rosuvastatin and furosemide by measuring drug concentration over time. Researchers will collect data up to approximately two weeks to analyze the area under the concentration-time curve (AUC0-inf) for both drugs. Safety assessments and health evaluations will also take place to ensure participant wellbeing throughout the study period.

Researchers are evaluating the safety and effectiveness of the FloStent, a medical device designed to treat men experiencing symptoms of Benign Prostatic Hyperplasia (BPH). This clinical study compares the FloStent to a sham procedure, which involves flexible cystoscopy without deploying the device. The purpose is to assess how well the FloStent improves urinary symptoms in men with BPH. Participants will undergo a flexible cystoscopy. Those assigned to the treatment group will have the FloStent deployed during the procedure, while those in the control group will have the cystoscopy without device deployment. The study is designed as a prospective, multicenter, double-blind, randomized trial ensuring unbiased results. During the 12-month study period, researchers will monitor changes in participants' International Prostate Symptom Score (IPSS) to measure symptom improvement. Participants must complete all study visits and protocols as part of their involvement. Safety and effectiveness outcomes will be carefully tracked throughout the trial.

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 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 focuses on men with prostate cancer who have previously participated in an enzalutamide clinical study sponsored by Astellas or Medivation. It aims to gather long-term safety information from participants who continue to benefit from enzalutamide treatment. This is a Phase 2 open-label extension study designed to monitor ongoing treatment effects after the initial study has completed its primary analysis or evaluation period. Participants will continue their previous treatment regimens, which may include enzalutamide taken orally once daily. Some may also receive abiraterone acetate with prednisone or leuprolide acetate depending on their prior study enrollment. Dose adjustments are allowed with medical monitor approval. The first visit of this study should occur within seven days of the last visit of the prior study unless treatment is temporarily paused. Participants are asked to return to their study site every 24 weeks for safety reviews, including adverse event monitoring and medication checks. At visits every 12 weeks, participants return unused study drugs and receive new supplies if needed. Safety data, including all adverse events and serious adverse events, are collected from consent until study completion, which may last up to 96 months. The study follows local standard care guidelines and includes a post-marketing phase in South Korea.

Researchers are evaluating the efficacy and safety of a drug called azenosertib (ZN-c3) in women with platinum-resistant, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. This Phase 2 study focuses on patients whose tumors test positive for Cyclin E1 protein, determined by a specific assay developed by the sponsor. The study aims to understand how well azenosertib works in this group and its safety profile. The study involves administering azenosertib orally to participants. It is divided into two parts: Part 1 included all patients regardless of biomarker status and has completed enrollment; Part 2 requires tumors to be Cyclin E1 positive. Participants receive azenosertib and are monitored throughout the study according to the protocol. Participants will be involved in various assessments including tumor measurements following RECIST version 1.1 criteria up to about 12 months after the last participant enrolls. Researchers will track the objective response rate to evaluate tumor response. Safety and efficacy evaluations, along with monitoring of side effects and overall health, will take place during the study period to gather comprehensive data on the treatment.

Researchers are studying how different doses of brenipatide, given as injections under the skin, work and how safe they are in healthy adults who are overweight or have obesity. The study focuses on people with a body mass index (BMI) between 27.0 and 45.0 kg/m² who do not have related health problems like type 2 diabetes or unstable heart disease. This is a Phase 1b trial that compares brenipatide with a placebo, aiming to understand the drug's effects on body weight and safety. Participants will receive multiple doses of brenipatide or placebo through subcutaneous injections during the study. The trial is randomized and blinded, meaning neither the participants nor the researchers know who is receiving the active drug or placebo. The treatment period and dosing details are structured to evaluate how different dose levels affect the body over time. During about 42 weeks of participation, individuals will be closely monitored for changes in body weight, with primary measurements taken at Week 1 and Week 29. Researchers will assess safety, tolerability, and how the drug behaves in the body. Participants will undergo evaluations to ensure they remain healthy and to track any side effects or changes related to the study drug.

Researchers are evaluating the safety and effectiveness of brenipatide compared to placebo for people with opioid use disorder. This study focuses on participants who are also using buprenorphine, with or without naloxone, as part of their treatment. The trial includes two parts, each with separate groups of participants, to better understand how brenipatide works alongside current therapies in early recovery from opioid use disorder. The study has two parts: Part A involves a double-blind treatment phase followed by an open-label extension, while Part B offers an open-label treatment only. Brenipatide and placebo are given as subcutaneous injections, and buprenorphine is administered either sublingually or buccally. Participants will be enrolled in only one part of the study, with treatment durations potentially lasting up to 144 weeks in Part A and 116 weeks in Part B, depending on enrollment timing and study progress. Participants will regularly attend study visits where they will be assessed through urine drug screens and self-reports to measure abstinence from opioid use. They will also maintain study diaries and complete questionnaires to track adherence and effects. The main outcomes measured include the percentage of weeks participants remain abstinent from opioids between weeks 13 and 24, verified by negative drug tests and no self-reported opioid use. Safety and long-term effectiveness will be monitored throughout the study duration.

Researchers are investigating the long-term safety of buntanetap in people with Parkinson's Disease (PD) over a 36-month period. This open-label study includes two groups: one with participants previously involved in buntanetap trials and another with those receiving deep brain stimulation (DBS) treatment. The study focuses on evaluating safety outcomes, including adverse and serious adverse events during treatment. Qualified participants will receive a daily oral dose of 30 mg buntanetap after a screening period lasting up to 42 days. Cohort 1 includes invited participants from prior buntanetap studies, who will stop their standard PD medications 12 hours before baseline and annual visits to ensure an OFF medication state. Cohort 2 includes participants treated with DBS for at least 12 months; they will stop PD medications 12 hours prior to all clinic visits and adjust their DBS settings to baseline the night before these visits. Throughout the study, participants will be assessed by trained clinicians using cognitive and motor evaluations such as MMSE, MoCA, C-SSRS, and MDS-UPDRS. Each participant is assessed by the same clinician during the study. Researchers will monitor treatment safety, adverse events, and emergent side effects for 36 months. Participants must have a support person for study visits, and certain medication and health stability requirements apply. The total participation can last up to three years, including regular clinical visits and assessments.

Researchers are evaluating the drug disitamab vedotin, alone or combined with pembrolizumab, to treat urothelial cancer that expresses HER2. This cancer is locally advanced, cannot be removed by surgery, or has spread to other parts of the body. The study aims to see how well the drug works and how safe it is for participants by monitoring side effects and treatment responses. Participants will receive disitamab vedotin through an intravenous (IV) infusion every two weeks. Pembrolizumab, when given, is administered by IV on the first day of each six-week cycle. The study includes several groups, called cohorts, each with different treatment histories and eligibility criteria. Treatment and evaluation may continue for about two years. During the study, participants will have regular tests including scans to measure tumor response, lab tests, heart function checks, and monitoring for adverse events. Researchers will also track drug levels in the blood and any changes in heart function. The study will assess confirmed tumor responses and safety outcomes over approximately two years, with close monitoring to understand how participants respond to the treatments and any side effects experienced.