Bruce

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are studying the effectiveness and safety of KAI-9531, a drug given as a once-weekly subcutaneous injection, in adults living with obesity who do not have diabetes. The study aims to show that KAI-9531 leads to greater weight loss compared to semaglutide, another injection given weekly, and a placebo. This is a Phase 3 randomized, partially-blinded trial that compares these treatments in people with a body mass index (BMI) of 35 kg/m² or higher who have tried and failed to lose weight through diet and exercise within the last six months. Participants will be assigned to receive either KAI-9531, semaglutide, or a placebo, all administered by subcutaneous injection once a week. The study will monitor changes in body weight over a period of 76 weeks to assess which treatment is more effective. The trial design includes active and placebo-controlled groups to carefully evaluate the impact of KAI-9531 on weight management. During the study, participants will undergo assessments to measure their body weight and other health parameters at baseline and throughout the 76-week period. The main outcome being measured is the percent change in body weight from the start of the study to week 76. Safety and tolerability of the treatments will also be monitored. Participants will be followed closely to ensure adherence and to track any side effects or changes in health status throughout the study duration.

Researchers are studying the effects of a drug called KAI-9531, given as a subcutaneous injection once a week, in adults living with obesity or overweight who also have type 2 diabetes. The main goal is to see if KAI-9531 is better than a placebo at reducing body weight and lowering hemoglobin A1c (HbA1c), a measure of blood sugar control, over a 76-week period. This Phase 3, randomized, double-blind, placebo-controlled trial focuses on those who have tried and struggled to lose weight through diet and exercise. Participants receive either KAI-9531 or a placebo through weekly injections under the skin. The study compares doses 3 and 4 of KAI-9531 against placebo to evaluate changes in body weight and HbA1c from the start of the study to week 76. The treatment is monitored closely throughout the trial to assess effectiveness and safety. During the study, participants will have their body weight and HbA1c measured at baseline and again at week 76 to observe changes. Researchers will also monitor safety and any side effects. The overall participation includes regular follow-ups and assessments to track progress and health status over the study duration.

Researchers are evaluating the safety and outcomes of different surgical margin sizes for adults with stage II primary invasive cutaneous melanoma. The trial compares the effects of removing 1 cm versus 2 cm of healthy skin around the melanoma site to see if smaller margins provide similar disease control. This study aims to understand if narrower excision margins can reduce surgery side effects and improve quality of life without increasing the risk of melanoma returning. Participants will be randomly assigned to undergo wide local excision surgery with either a 1 cm or 2 cm margin around the original melanoma scar. Both approaches involve removing an extra margin of skin to eliminate any remaining melanoma cells after the initial biopsy. Surgery is scheduled to be completed within 120 days after diagnosis and within 28 days after randomization. This phase III, multi-center trial will assess if the smaller margin is as effective as the larger one. During the study, patients will be followed for up to 60 months to monitor disease-free survival, which means the length of time without melanoma recurrence. Researchers will also evaluate quality of life, side effects from surgery, and the economic impact on health services. Participants will have regular clinical assessments, and outcomes will be recorded to determine the long-term safety and benefits of the two surgical approaches.

Researchers are evaluating a Chlamydia messenger RNA (mRNA) vaccine candidate in adults aged 18 to 29 years. This Phase 1/2 study aims to assess the safety, immune response, and effectiveness of three dose levels (low, medium, and high) of the vaccine. The study includes three initial Sentinel Cohorts to carefully monitor safety before progressing to a Main Cohort, ensuring participant well-being throughout the process. The study involves intramuscular injections of either the Chlamydia mRNA vaccine or a placebo solution. Participants in the Sentinel Cohorts receive different dose levels in a stepwise manner to identify safe dosing. After the initial safety assessment, the Main Cohort participants receive study interventions accordingly. Each participant undergoes follow-up for up to 12 months after their last dose, with the total participation lasting about 18 months. During the study, researchers closely monitor for immediate and delayed adverse events, including injection site and systemic reactions, up to 7 days after each injection. They also track unsolicited and medically attended adverse events up to 6 months and serious or special interest events up to 12 months after the final dose. Additional safety monitoring includes biological test results in a specific safety subset. This extensive follow-up helps ensure a thorough evaluation of the vaccine's safety and immune response over time.