El Dorado

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.

The goal of this trial is to determine the efficacy of advanced cognitive training for cancer survivors suffering from cancer- and cancer-treatment-related cognitive dysfunction. For millions of cancer survivors, cognitive dysfunction is a prevalent, severe, and persistent problem that has long been associated with poor work-related and health-related outcomes. Evidence suggests that a significant subset of breast cancer survivors (BCS) incur cognitive changes that may persist for years after treatment. Unfortunately, the scientific basis for managing these cognitive changes is extremely limited. Available evidence from pilot studies, including our work, suggests that advanced cognitive training, which is based on the principles of neuroplasticity (ability of brain neurons to re-organize and form new neural networks), may be a viable treatment option. However, previous trials to date have been limited by lack of attention-controlled designs, small samples of BCS, or limited outcome measures. Therefore, to overcome limitations of past studies and build on our pilot results, the purpose of this 2-group, double-blind, randomized controlled trial is to conduct a full-scale efficacy trial to compare advanced cognitive training to attention control in BCS.

Researchers are collecting and storing tissue and blood samples from patients with various types of cancer to create models that help study cancer and test new treatments. This observational study focuses on patients with confirmed or suspected cancer diagnoses, including solid tumors and hematologic malignancies, to improve laboratory research and drug development. The study involves obtaining tumor tissue and blood samples during medically necessary procedures related to the patient's cancer treatment. These samples will be preserved using xenograft models (transplantation into another species) or cell cultures for future analysis. Sample collection is timed carefully around treatment cycles to ensure tissue viability. Participants will undergo tissue and blood collection as part of their clinical care, with no additional procedures solely for the study. Researchers will review pathology and flow cytometry reports to confirm viable cancer cells in the samples. The main outcome is the successful procurement and storage of these biological materials for research over a follow-up period of up to five years.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are evaluating the effectiveness and safety of GL0034 in adults with type II diabetes who are overweight or obese and have related health conditions. This phase II, randomized, double-blind, placebo-controlled study aims to compare various doses of GL0034 against a placebo to understand its impact on blood sugar control, specifically measuring changes in HbA1c levels over 36 weeks. Participants will receive weekly subcutaneous injections of GL0034 at one of six dose levels or a placebo following an initial dose titration period that can last up to about 20 weeks. The study includes multiple treatment arms and a placebo arm, with dosing maintained once a week throughout the study. During the 36-week treatment period, participants will undergo blood tests to monitor HbA1c and other health indicators. They will also perform home blood glucose monitoring and use an electronic device to record their responses. Researchers will track safety and tolerability while assessing changes in blood sugar control from the start to the end of the study.

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled Phase 2 study to assess the efficacy and safety of iloperidone for treating adults aged 18 to 65 with uncontrolled hypertension. The study focuses on participants whose systolic blood pressure remains 130 mmHg or higher despite at least 8 weeks of treatment with one or more antihypertensive therapies. This trial aims to understand how iloperidone affects blood pressure control in this population. Participants will be randomly assigned to receive either iloperidone or a placebo. The treatments are administered as drugs, with participants and researchers blinded to the assignments. The study measures changes in systolic blood pressure from baseline to the fourth week of treatment to evaluate the effects of iloperidone compared to placebo. During the study, participants will undergo blood pressure monitoring and safety assessments. The primary outcome is the change in sitting systolic blood pressure after 4 weeks of treatment. The study excludes individuals with severe hypertension, unstable heart disease, or kidney problems to ensure participant safety. The trial duration includes at least 4 weeks of treatment, with ongoing monitoring for efficacy and safety.

Type 2 diabetes is a condition where the body does not respond well to insulin, leading to high blood sugar levels that can cause serious health problems. This research evaluates HP-211, a botanical extract derived from common herbs and vegetables, which has shown promise in laboratory and animal studies to enhance insulin's ability to help cells absorb glucose. The study aims to see if HP-211 can reduce blood sugar and insulin levels in people with type 2 diabetes, especially those who are insulin-resistant, over a 90-day treatment period. Participants will take 0, 1, 2, or 3 tablets of HP-211 twice daily, preferably at least 60 minutes before meals, for 90 days. The study compares different doses of HP-211 to a placebo, all taken orally in the morning and evening. Researchers will measure hemoglobin A1c (HbA1c), which reflects average blood glucose levels over time, to assess the treatment's effect. Additional measures of glucose control and safety will also be monitored throughout the study. During the trial, participants will undergo blood tests to measure HbA1c and other markers of glucose control. Safety assessments will include monitoring blood pressure, heart rhythm via ECG, and other health evaluations. The primary outcome is the change in HbA1c after 12 weeks of treatment. Participants must have type 2 diabetes diagnosed within the last 5 years and be on stable metformin therapy or diet and exercise. The total participation time includes screening and 90 days of treatment with regular study visits for assessments.

Researchers are evaluating the immune response, safety, and tolerability of the rF1V-1018 vaccine in healthy adults aged 18 to 55. This phase 2 randomized multicenter trial focuses on finding the best dose and regimen of the vaccine to prevent pneumonic plague caused by aerosol exposure to Yersinia pestis. The study includes participants who are healthy or have stable medical conditions without recent major changes or hospitalizations. The study tests six different dosing regimens of the rF1V-1018 vaccine in the first part. From these, up to two regimens will be selected for further evaluation in the second part of the study. Participants will receive injections according to their assigned regimen. The study monitors injection reactions shortly after vaccination and follows participants for adverse events, serious adverse events, and immune-mediated adverse events for up to six months after the final vaccine dose. Participants will visit the clinic periodically for blood samples to measure immune response and for safety check-ups throughout the trial. Safety assessments will continue regularly until the study ends. Researchers will measure antibody levels against the vaccine four weeks after the final dose and carefully track any reactions or side effects to evaluate the vaccine's tolerability and safety.

Researchers are evaluating a screening and multi-sub-study randomized phase II/III trial called Lung-MAP, designed for patients with previously treated non-small cell lung cancer. The trial aims to establish a genomic screening method to assign patients to biomarker-driven or non-matched sub-studies. Depending on the cancer biomarker type, participants may receive new targeted cancer therapies or combinations compared to standard care, with the goal of approving new treatments. An optional ancillary study explores patient and physician attitudes about returning genetic findings related to germline mutations. The study involves testing patient specimens to determine eligibility for various sub-studies under the Lung-MAP protocol. Patients undergo screening to analyze tumor tissue and blood samples for biomarkers including PD-L1 and c-MET. Those requiring a fresh biopsy also submit blood for circulating tumor DNA testing. Sub-study assignment depends on the molecular profile results. This screening process includes both patients progressing after prior therapy and those pre-screened before progression on current treatment. Participants provide informed consent and tumor tissue that meets quality standards for testing. Researchers collect clinical data including smoking history and performance status. Outcomes focus on screening success, such as adequate tissue submission and matching to biomarker-driven sub-studies, tracked for up to three years. The study also monitors patient and physician knowledge and preferences regarding genomic findings. Participation duration varies based on screening and sub-study assignment.

Researchers are investigating whether observation is as effective as continuing pembrolizumab treatment in patients with early-stage triple-negative breast cancer who achieved a complete response after preoperative chemotherapy combined with pembrolizumab. This phase III trial aims to evaluate recurrence-free survival and quality of life, as well as the value of reducing immunotherapy treatment after surgery in these patients. The study also examines differences in adverse events, overall survival, and financial impacts between treatment approaches. Participants are randomly assigned to one of two groups after completing neoadjuvant chemotherapy with pembrolizumab and surgery. One group receives pembrolizumab intravenously as adjuvant therapy, while the other group undergoes observation without further treatment. Both groups have tumor biopsies and blood samples collected on study and during follow-up. Additional assessments include questionnaires and quality-of-life evaluations. During the study, researchers monitor participants for up to 10 years to measure recurrence-free survival. They assess quality of life using validated tools, track adverse events, and evaluate financial toxicity and work productivity. The study includes tumor tissue analysis, blood sample collection, and patient-reported outcomes to understand the long-term effects and value of treatment de-escalation in breast cancer care.