Burke

Researchers are investigating the effects of obicetrapib 10 mg, both combined with ezetimibe 10 mg as a fixed-dose combination and as monotherapy, in people with metabolic syndrome and/or Type 2 Diabetes Mellitus who are already receiving standard lipid-lowering therapy. This Phase 3, placebo-controlled, double-blind, randomized study aims to evaluate how well these treatments lower LDL cholesterol and assess their safety and tolerability. Participants will be assigned to one of three groups: obicetrapib 10 mg plus ezetimibe 10 mg fixed-dose combination, obicetrapib 10 mg alone, or placebo, all added to their existing guideline-recommended lipid-lowering therapy. The treatments are taken daily, and the study measures the percent change in LDL cholesterol from the start to Day 84. During the study, participants will undergo regular monitoring including lipid measurements and safety assessments. Researchers will carefully track changes in LDL cholesterol and other health markers over the 84-day treatment period. The study focuses on how these treatments perform in real-world patients with metabolic syndrome or Type 2 Diabetes while continuing standard care.

Researchers are investigating the effects of Tradipitant on nausea and vomiting caused by GLP-1 receptor agonist use in adults who are either overweight with at least one weight-related condition or have class I or class II obesity. This Phase 3 study compares Tradipitant to a placebo to evaluate its ability to reduce these symptoms. Participants will be randomly assigned to receive either oral Tradipitant capsules or oral placebo capsules. The study is double-blind, meaning neither participants nor researchers know which treatment is given. The treatment period involves monitoring symptoms closely to assess the impact of Tradipitant compared to placebo. During the study, participants will keep a daily symptom diary to track vomiting episodes and nausea. Researchers will focus on the proportion of participants experiencing at least one vomiting episode per week. The study includes safety monitoring and will last at least one week, with careful assessments to understand the treatment's effects.

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 evaluating how to best recommend chemotherapy for patients with colon cancer after surgery by using the presence or absence of circulating tumor DNA (ctDNA) in the blood. This approach aims to identify microscopic residual tumor cells and may provide better risk prediction for cancer recurrence compared to traditional methods. The trial focuses on patients with Stage IIB, IIC, or III colon cancer who have undergone complete tumor removal. Participants will have their tumor tissue and blood tested centrally using the Signatera assay to determine ctDNA status. Patients without detectable ctDNA may avoid chemotherapy, while those with detectable ctDNA are considered at higher risk and will be randomly assigned to receive different chemotherapy regimens, including mFOLFOX6, CAPOX, or mFOLFIRINOX, given intravenously or orally over periods ranging from 3 to 6 months. The study includes initial screening, treatment, and possible second randomization for patients whose ctDNA status changes during monitoring. During the study, participants will undergo various assessments including blood tests, imaging scans, and performance evaluations to monitor their health and response to therapy. Researchers will track the time to ctDNA positivity and disease-free survival for up to 3 and 5 years, respectively. Safety and treatment effects will be closely observed throughout the study duration, ensuring thorough follow-up and monitoring for all participants.

Researchers are evaluating if adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival (IBCFS) compared to OFS plus ET alone. This Phase III trial focuses on premenopausal women with early-stage breast cancer that is estrogen receptor (ER)-positive, HER2-negative, and has a 21-gene recurrence score between 16-25 for node-negative patients or 0-25 for patients with 1-3 positive nodes. The study addresses the need for better treatment options for younger women diagnosed with this type of breast cancer, as younger age is linked to worse outcomes despite standard therapies. Participants receive one of two treatments: either OFS combined with an aromatase inhibitor (AI) for five years or adjuvant chemotherapy followed by the same OFS plus AI regimen. The specific AI and GnRH agonist used, along with their dosing schedules, are chosen by the investigator, commonly including goserelin, leuprolide, or triptorelin administered monthly or every three months. Bilateral oophorectomy may be used instead of ovarian suppression if preferred. Endocrine therapy beyond five years is at the investigator's discretion. During the trial, participants will be closely monitored for invasive breast cancer-free survival over an 11-year period from randomization. Assessments include clinical evaluations, hormone receptor testing, tumor staging, and genetic recurrence scoring prior to enrollment. Safety and effectiveness data will be collected throughout the study, with particular attention to treatment side effects and long-term outcomes. The trial involves detailed eligibility screening and ongoing follow-up to ensure accurate measurement of the study's primary outcome.

Researchers are evaluating the effects of two inhalers, budesonide/albuterol metered-dose inhaler (BDA MDI) and albuterol sulfate metered-dose inhaler (AS MDI), both taken as needed, on reducing severe asthma attacks in adolescents aged 12 to under 18 years who have a clinical diagnosis of asthma and have experienced at least one severe asthma exacerbation in the past year. This is a Phase IIIb randomized, double-blind, multicenter study lasting 52 weeks with a safety follow-up period after treatment. Participants will be randomly assigned to receive either BDA MDI 160/180 micrograms (two puffs of 80/90 micrograms) or AS MDI 180 micrograms (two puffs of 90 micrograms) as needed, alongside their usual asthma maintenance therapy, for 52 weeks. The study includes a 7 to 28-day screening period before treatment and a safety follow-up visit 7 to 14 days after the end of treatment. Additionally, a pharmacokinetic sub-study involves a single dose of open-label BDA MDI administered after the safety follow-up. During the study, participants will be monitored for the annual rate of severe asthma exacerbations from randomization to week 52. Assessments include evaluating inhaler technique, peak expiratory flow measurements, and adherence to contraception methods for participants of childbearing potential. Safety will be monitored throughout the treatment and follow-up periods. The total study duration includes screening, 52 weeks of treatment, and safety follow-up.

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.

Researchers are evaluating the incidence of colorectal cancer in people aged 45 to 70 who have 1 to 2 non-advanced adenomas, which are small precancerous polyps without high-risk features. The study compares outcomes between those who have surveillance colonoscopies every 5 years versus every 10 years. This is important because current guidelines recommend follow-up colonoscopy but lack clear evidence on the best timing for patients with non-advanced adenomas. Participants will undergo colonoscopies at either 5 and 10 years or just at 10 years after their initial qualifying colonoscopy. All colonoscopies, including any unscheduled ones, will follow standard quality procedures and preparation instructions. The initial colonoscopy must have fully visualized the cecum and completely removed all polyps. Sessile serrated polyps without advanced features are also included as non-advanced adenomas. During the trial, researchers will monitor participants through colonoscopy exams and collect data on the incidence of colorectal cancer over a 10-year period. The main measurement is the rate of colorectal cancer occurrence. The study also includes assessments to ensure adherence to colonoscopy quality standards and will follow participants long term to observe safety and effectiveness of the surveillance intervals.

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 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.