Burke

Researchers are evaluating the long-term effects of aleniglipron, a drug taken orally, in adults with overweight or obesity who also have type 2 diabetes mellitus T2DM. This is a randomized, double-blind, placebo-controlled Phase 3 study designed to assess the drugs effectiveness, safety, and tolerability over an extended period. The study focuses on the management of weight and diabetes in this population. Participants will be randomly assigned to receive either aleniglipron or a placebo, all administered orally. The treatment period lasts for 76 weeks, during which participants will take multiple doses of the assigned medication. The study includes three different aleniglipron arms and one placebo arm, all aiming to evaluate weight change and diabetes control over time. Throughout the study, participants will undergo assessments to measure changes in body weight, waist circumference, HbA1c levels, blood pressure, and cholesterol levels. The primary outcome is the percent change in body weight from the start of the study to week 76. Secondary outcomes include the proportion of participants achieving various levels of weight loss and diabetes targets. The study also monitors safety and tolerability during the treatment period, which lasts approximately 76 weeks.

Researchers are evaluating the effects of obicetrapib 10 mg, alone and combined with ezetimibe 10 mg, alongside standard lipid-lowering treatment in adults with metabolic syndrome andor Type 2 Diabetes Mellitus. This Phase 3, randomized, placebo-controlled, double-blind study aims to assess how these treatments affect cholesterol levels and their safety and tolerability. Participants will be assigned to one of three groups a fixed-dose combination daily of obicetrapib 10 mg plus ezetimibe 10 mg, obicetrapib 10 mg alone daily, or a placebo with standard lipid-lowering therapy. After the initial treatment period, there is an open-label extension where all may receive the combination of obicetrapib and ezetimibe. The study treatments are taken daily. During the study, participants will have their cholesterol and lipid levels measured at the start and after 84 days to evaluate changes in LDL-C and other lipid markers. The research team will monitor safety, tolerability, and other blood markers related to cholesterol. The entire study period includes initial treatment and an extension phase, with ongoing evaluations to understand how the treatments influence lipid levels and patient health.

Researchers are evaluating the effects of Tradipitant on treating nausea and vomiting caused by GLP-1 receptor agonist use in adults who are overweight or have class I or II obesity. This phase 3, randomized, placebo-controlled study includes healthy volunteers without serious medical issues or diabetes. The goal is to better understand how Tradipitant impacts these symptoms compared to a placebo. Participants will be randomly assigned to receive either Tradipitant or a placebo, both given as oral capsules twice daily for about two weeks. The study has two treatment arms one receiving Tradipitant and the other receiving a placebo. The study uses quadruple masking to ensure unbiased results. During the study, participants will record nausea and vomiting symptoms daily in a symptom diary. Researchers will measure the proportion of participants experiencing vomiting episodes and assess nausea severity over one week. The study will monitor safety and side effects throughout, with the total participation duration around two weeks of treatment.

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.

Researchers are studying premenopausal women with early-stage breast cancer that is estrogen receptor-positive and HER2-negative, focusing on tumors with specific gene recurrence scores. The trial aims to find out if adding chemotherapy to ovarian function suppression plus endocrine therapy improves invasive breast cancer-free survival compared to ovarian function suppression plus endocrine therapy alone. This Phase III trial addresses the need for better treatments in younger women, given their higher risk and past conflicting study results on ovarian suppression and chemotherapy. Participants are randomly assigned to one of two groups one receiving ovarian function suppression combined with an aromatase inhibitor for five years, and the other receiving adjuvant chemotherapy followed by the same ovarian function suppression and aromatase inhibitor regimen. Choices for the aromatase inhibitor and gonadotropin releasing hormone agonist are made by the investigator, with options including drugs such as goserelin, leuprolide, or triptorelin. Endocrine treatment beyond five years is at the investigators discretion, and bilateral oophorectomy may be used instead of ovarian suppression if preferred. During the study, participants are monitored over 11 years from randomization, with measurements including invasive breast cancer-free survival as the primary outcome. Secondary outcomes include disease-free survival, overall survival, recurrence intervals, menopausal symptoms, and pain during aromatase inhibitor therapy. Safety and treatment effects are assessed through regular evaluations, and participants continue to be followed long term to understand the impact of treatments on their breast cancer outcomes.

This research aims to compare the effects of two inhalers, budesonidealbuterol metered-dose inhaler BDA MDI and albuterol sulfate metered-dose inhaler AS MDI, both used as needed, in adolescents aged 12 to 17 years with asthma. The study focuses on their impact on the annual rate of severe asthma attacks in participants who have a documented diagnosis of asthma and at least one severe exacerbation in the past year. This is a randomized, double-blind, multicenter Phase IIIb trial. Participants are randomly assigned in equal numbers to receive either BDA MDI 160180 micrograms 2 puffs of 8090 micrograms or AS MDI 180 micrograms 2 puffs of 90 micrograms as needed, alongside their usual maintenance asthma therapy. The study includes a 7 to 28-day screening period, a 52-week treatment period, and a safety follow-up lasting 7 to 14 days after treatment ends. Additionally, a pharmacokinetic sub-study involves a single dose of open-label BDA MDI administered at a separate visit after safety follow-up. During the study, participants will be monitored through regular assessments including lung function tests such as peak expiratory flow, evaluation of asthma exacerbations, and safety checks for adverse events. The main outcome measured is the annualized rate of severe asthma exacerbations over the 52-week treatment. Safety follow-up and pharmacokinetic evaluations will further assess drug concentrations and participant well-being. Overall participation lasts from screening through safety monitoring after treatment completion.

This clinical trial is investigating iloperidone as a potential treatment for people with uncontrolled hypertension, a condition where blood pressure remains high despite treatment. The study is designed as a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial to evaluate both the effectiveness and safety of iloperidone for this condition. Participants will be randomly assigned to receive either iloperidone or a placebo. The study involves careful monitoring over a treatment period of 4 weeks to assess changes in systolic blood pressure. Both the experimental drug and placebo are given under controlled conditions, and neither the participants nor the researchers know who receives which. During the study, participants systolic blood pressure will be measured from baseline through week 4 to evaluate treatment response. Safety and any side effects will be monitored closely. The total study duration includes initial screening followed by the 4-week treatment period. Participants will have regular visits for blood pressure measurements and health assessments throughout the trial.

Researchers are studying colorectal cancer CRC in participants aged 45 to 70 who have 1 to 2 non-advanced adenomas, which are small colon polyps without high-risk features. The trial compares two surveillance colonoscopy schedules one group receives colonoscopy at 5 and 10 years after polyp detection, while the other group has colonoscopy only at 10 years. This study aims to provide randomized data to guide optimal timing for follow-up colonoscopies to help reduce CRC incidence and improve clinical practices. Participants are randomly assigned to one of two groups the first group undergoes surveillance colonoscopy at both 5 and 10 years following their qualifying colonoscopy, and the second group undergoes colonoscopy at 10 years only. All colonoscopies, including any unscheduled ones, follow current quality guidelines and institutional preparation standards. The qualifying colonoscopy must have been complete and performed within 4 years before randomization, with all polyps fully removed. During the study, participants will undergo colonoscopies according to their assigned schedules. Researchers will monitor the incidence of colorectal cancer over 10 years as the primary outcome. Participants must be able to understand English or Spanish to complete required procedures. The study may last up to several decades, with ongoing monitoring to assess long-term cancer incidence and the effectiveness of different surveillance intervals.

Researchers are studying type 2 diabetes, a condition where the body cannot properly use insulin to control blood sugar, leading to complications like heart disease, kidney failure, and nerve damage. This research evaluates a botanical extract called HP-211, which has shown promise in lab and animal studies for helping insulin work better to lower blood sugar and insulin levels. The goal is to see if HP-211 can reduce blood glucose and insulin responses in people with type 2 diabetes, especially those with insulin resistance. Participants will be randomly assigned to receive different doses of HP-2110.98 grams, 1.96 grams, or 2.94 grams twice dailyor a placebo, taken as tablets in the morning and evening for 90 days, preferably at least 60 minutes before meals. The study includes a dose-ranging phase to test safety and proof of concept by comparing these doses. Researchers will monitor changes in blood sugar control and insulin levels during the treatment period. Throughout the trial, participants will have blood tests to measure hemoglobin A1c HbA1c, which reflects average blood sugar over time, as well as fasting blood glucose and self-monitored blood glucose profiles. Safety assessments will track adverse events, body weight, and quality of life related to diabetes treatment. The study lasts 12 weeks of treatment plus 4 weeks of withdrawal monitoring, with ongoing evaluations to assess the effects and safety of HP-211 on blood sugar control.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.